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Comparison of two different file systems on postoperative pain after root canal instrumentation: A randomized controlled trial

Comparison of two different file systems on postoperative pain after root canal instrumentation:... Acta Marisiensis - Seria Medica 2023;69(1):37-44 DOI: 10.2478/amma-2023-0006 RESEARCH ARTICLE Comparison of two different file systems on postoperative pain after root canal instrumentation: A randomized controlled trial 1* 2 1 3 4 Saad Shahnawaz , Nabiya Shahroz , Muhammad Ahmed Zafar , Shahroz Sajjad , Mehwish Pasha , Arfa Sabir Hussain 1. Operative and Endodontic Department Islamic International Dental Hospital, Islamabad, Pakistan 2. Operative and Endodontic Department Shifa international hospital, Islamabad, Pakistan 3. Operative and Endodontic Department Armed Forces Institute of Dentistry, Islamabad, Pakistan 4. Dental materials Department, Shifa international hospital, Islamabad, Pakistan Introduction: In this study post instrumentation pain is evaluated between rotary hyflex CM files and conventional k-files at different time intervals. Methodology: fifty patients were equally assigned into two groups and instrumented using hyflex cm or conventional files. VAS for pain was noted before the start of a root canal and after the procedure at 12, 24, and 48 hours. Results: There was no significant difference at 12, 24, and 48 hours with P values being 0.127, 0.867, and 0.846 respectively. Conclusion: There is no significant difference in causing post-instrumentation pain between hyflex CM and conventional files at different time intervals. However, when accessing preop pain of the conventional file group, it had more pain mean score compared to hyflex group. According to this study, Conventional files may be able to slightly decrease the chances of post-instrumentation pain more than hyflex CM instrumentation. Keywords: hyflex CM, post instrumentation, conventional files, VAS Received 13 December 2022 / Accepted 6 February 2023 Introduction debris, irrigant or filling material [6, 7]. One of the integral The success of endodontic treatment depends upon proper part of endodontic treatment is prevention and manage- root canal instrumentation, debridement, disinfection, and ment of this post endodontic pain. According to studies three-dimensional apical seal to coronal seal [1]. However reported, frequency of post endodontic pain may range certain canal morphologies, preparation techniques, and from 16% to 50% in endodontic cases [8]. armamentarium may pose a challenge in achieving these Pain may occur after root canal preparation due to re- goals. Due to the vast complexity of endodontic factors, maining endodontic microbiota within the canal system there has been a huge advancement in the instrumentation and the extrusion of dentinal debris beyond the apex [9]. system. The introduction of the Nickel-titanium rotary Root canal treatment can be done in single or multiple systems has brought a paradigm shift in endodontics due visits. It has been shown that patients prefer single-visit to its ability to respect the canal curvature and morphol- treatment due to decreased number of operative visits, less ogy [2, 3]. time-consuming, and more economical [1, 10, 11]. The initially introduced rotary file systems brought the Post-instrumentation pain presents as a common find - challenge of file breakage, ledge formation, and perfora - ing, the dentist should not get worried and not immedi- tions. Further advancement in these systems lead to the ately initiate retreatment or extraction [12]. Also patients development of a ‘controlled memory file’ (Hyflex CM should be made aware of post-instrumentation pain and coltene) [4]. This file was made by CM wire which had the analgesic medication prescribed accordingly. This not only property to attain the shape of the curved canal even when encourages an anxious patient for treatment but provides out of the canal [5]. This six-file system had the advantage the dentist with the patient’s compliance, cooperation, of having high fatigue resistance and drastically reducing confidence and increases the dentist’s rapport [13]. The the chances of ledge formation, transportation, and perfo- shift from hand instrumentation to rotary systems has led rations, especially in curved canals. to better cleaning and shaping of canal anatomy in less Post-operative pain is the most frequent complication time duration, which has made rotary instrumentation a that is encountered during root canal treatment which can desired preference among patients and dentists [14-16]. be due to insufficient root canal preparation, debris or in - This study therefore aims to clinically compare single visit tracanal medicaments, presence of preoperative pain, peri- post instrumentation pain between rotary file system Hy - apical pathosis, canal apical patency and apical extrusion of flex CM and conventional hand K-file system and their possible impact on pain. * Correspondence to: Saad Shahnawaz E-mail: saadahmed552@hotmail.com 38 Acta Marisiensis - Seria Medica 2023;69(1) Materials and Method Group 1 was assigned preparation with the rotary file This randomized control trial research was conducted in system Hyflex CM (Coltene, Switzerland) while group 2 the accordance with the Declaration of Helsinki and by was prepared using conventional stainless-steel files (Mani, the regulations of the ethics committee of the Operative Japan). Each group consists of 25 participants. and Endodontic Department of Islamic International For group 1, the glide path was made using a conven- Dental hospital (Ref # 2021/007/007). The duration of tional hand file up to size 20 k-file. Followed by sequential study took approximately 12 months and was conducted canal preparation was initiated using Hyflex CM files as by a single operator. A total of 50 sample size patients were per the color coding red 0.08 taper (08/25), yellow 0.04 taken and divided into two groups giving 25 participants taper (04/20), red 0.04 taper (04/25), yellow 0.06 taper in each group. The sample size was decided using the Ope- (06/20) and lastly 0.30 tip diameter blue color-coded file nEpi sample size calculator keeping a confidence level of with 0.04 taper (04/30). 95%, with sample size (n) being 50. Copious irrigation between each file was done using The study was conducted between two different systems 5.25% NaOCl (Sodium Hypochlorite) with an irrigation that are the conventional hand K-file vs the Rotary file sys - needle (27gauge pulpdent double-sided vent) as deep with- tem Hyflex CM. The patients’ inclusion criteria were as in the canal as possible but within a range of less than 2mm follows: from the working length. Final irrigation with 5ml 5.25% – Permanent mature teeth having single roots. NaOCl, 5 ml 17% EDTA, and 5ml 2% Chlorhexidine – The age limit of the patient should ideally be between was done. 5ml distilled water was used following each ir- 20-60 years of age. rigation to avoid interaction of irrigants with each other – Initially, before treatment, the patient should fall in forming insoluble precipitates like para-chloroaniline [19]. the Visual Analogue Scale (VAS) “5” or more pre- The tooth was sealed by a temporary restorative material operatively. cavit (3M) till the next visit. – The tooth should be tender to percussion. For group 2, sequential stainless steel hand K-files up – Patients should have been diagnosed with Apical Pe- to size 30 were used, respecting the working length of the riodontitis and pulpal diagnosis should be irreversible canal, with the same irrigation protocol and temporary res- pulpitis or necrotic pulp. toration placed as mentioned above. – Patient with a necrotic tooth. Preoperative Pain and Pain after 12, 24, and 48 hours The exclusion criteria were as follows: were assessed by VAS for both groups. The patient was – Unrestorable grossly carious teeth, Perforated teeth contacted by the clinical assistant via telephone after 12, with poor prognosis, or broken-down roots. 24, and 48 hours to provide relevant information regard- – Patient self-medicating or taking prescribed antibio- ing pain rating. In the case of VAS being recorded above 9, tics or analgesics. analgesics were prescribed. – Teeth with any sort of complexity like dilaceration, or After 48 hours of data collection, patients were called internal or external root resorption. back for obturation with Gutta Percha cones of the respec- – Teeth with previously endodontic treatment. tive system and AH plus sealer (Dentsply, Sirona, USA) – Teeth with multiple roots. using the cold lateral condensation technique. Treatment – Teeth associated with draining abscess or sinus tract. was concluded by sealing the coronal access cavity with – Patients who had uncontrolled systemic diseases. dental adhesive and composite resin (3M Filtek Universal Patients were referred to the Operative and Endodontic composite, USA) [5]. Department. The pulpal and the apical diagnosis were con - firmed by the operator with the help of periapical digital Statistical analysis radiographic evaluation, periodontal evaluation, percus- Data analysis was done using Statistical Package sion, and use of the pulp tester. The treatment protocol for Social Sciences (IBM®  SPSS®  Statistics devel- was explained to the patient and an informed written oped by Norman H. Nie, Dale H. Bent, C. Hadlai consent form was signed for ethical consideration. VAS Hull, version 25, Chicago, USA). Descriptive statis- was presented as a numerical rating scale to the patient tics were expressed as mean and standard deviation. numbered from 0-10. The patient was explained pain Frequencies and mean VAS were calculated for each group intensity from “0” to be none and gradually increasing and tested for significance with Mann Whitney U test. The towards severe pain at a score of “10”. While score of effect of age and gender on VAS between the two groups is “5” being as moderate pain [17, 18]. also calculated using Mann Whitney U test. VAS was noted before the treatment. Patients were ran- domly assigned into two groups. Local anesthesia (Medic- Results aine, Korea) was administered and consisted of 2% lido- Patients enrolled in the clinical trial are shown in the fol- caine with epinephrine 1:100,000, and a rubber dam was lowing flow diagram in Figure 1. applied. Access opening and single visit canal preparation Demographic data are shown in Table 1, Table 2, and were done. Figure 2. Among the total participants of study 64% were CONSORT Flow Diagram Acta Marisiensis - Seria Medica 2023;69(1) 39 Assessed for eligibility (n=51) Enrollment Excluded (n=0)  Not meeting inclusion criteria (n=1)  Declined to participate (n=0)  Other reasons (n=0) Randomized (n=50) Allocation Allocated to intervention (n=25) Allocated to intervention (n=25)  Received allocated intervention (n=25)  Received allocated intervention (n=25)  Did not receive allocated intervention (give  Did not receive allocated intervention (give reasons) (n=0) reasons) (n=0) Follow-Up Lost to follow-up (give reasons) (n=0) Lost to follow-up (give reasons) (n=0) Discontinued intervention (give reasons) (n=0) Discontinued intervention (give reasons) (n=0) Analysis Analysed (n=25) Analysed (n=25)  Excluded from analysis (give reasons) (n=0)  Excluded from analysis (give reasons) (n=0) Fig. 1. Consort flow diagram Table1. Gender distribution in both groups gender Total male female Control hand K-files 12 13 25 group Hyflex CM 6 19 25 Total 18 32 50 Table 2. Jaw frequency in both groups maxilla mandible Total group Control hand K-files 14 11 25 Hyflex CM 14 11 25 Total 28 22 50 Fig. 2. Gender frequency in both groups 40 Acta Marisiensis - Seria Medica 2023;69(1) female and 36% were male. Also a total of 56% maxillary Among all the mean statistical values between the con- teeth were included in study and remaining 44% mandib- trol group and Hyflex CM group, genders group and jaws ular teeth. No significant difference was observed in caus - group, the similarity of decreasing pain is visible when ing post instrumentation pain between conventional K-file viewed on bar graph through 12,24 and 48 hour time pe- and Hyflex CM file system at 12, 24, and 48 hours (P riod. This can be seen in figure 3, 4 and 5 respectively. value 0.127,0.867,0.846 respectively) Table 3. Although a significant difference was observed in preop pain VAS in Discussion the conventional file group compared to Hyflex CM group In our study no significant difference was observed in post- (P=0.004). (Table 3) instrumentation pain among genders and jaws. Although When gender groups were analyzed no significant dif - the bar graph shows slightly more pain prevalence among ference was observed between the two groups at 12, 24, female patients but this could be due to more number of and 48 hours (P value 0.705, 0.172, 0.344 respectively) as female participants (64%) compared to males (34%) as shown in Table 4. shown in Figure D in this study. Other studies have shown On jaw analyses also no significant difference was ob - pain to be more prevalent among females compared to served between the two groups at 12, 24, and 48 hours (P males [20-22].These results could be due to higher num - value 0.579. 0.266, 0.696 respectively) as shown in Table ber of sample size taken by these studies which our study 5. lacked. While some studies show no relevant difference Table 3. Correlation between the two groups preo op pain VAS 12 hour VAS 24 hour VAS 48 hour VAS Mann-Whitney U 164.500 235.000 304.000 303.000 Wilcoxon W 489.500 560.000 629.000 628.000 Z -2.915 -1.525 -.168 -.194 Asymp. Sig. (2-tailed) .004 .127 .867 .846 Table 4. Correlation between the two genders preo op pain VAS 12 hour VAS 24 hour VAS 48 hour VAS Mann-Whitney U 207.000 269.500 221.500 243.500 Wilcoxon W 735.000 797.500 392.500 414.500 Z -1.662 -.379 -1.365 -.947 Asymp. Sig. (2-tailed) .096 .705 .172 .344 Table 5. Correlation between jaws preo op pain VAS 12 hour VAS 24 hour VAS 48 hour VAS Mann-Whitney U 306.500 280.000 252.000 289.000 Wilcoxon W 559.500 533.000 505.000 542.000 Z -.030 -.555 -1.112 -.391 Asymp. Sig. (2-tailed) .976 .579 .266 .696 Fig. 3. Bar graph for mean statistics of manual group and Hyflex CM group Acta Marisiensis - Seria Medica 2023;69(1) 41 Fig. 4. Bar graph for mean statistics of gender group Fig. 5. Bar graph for mean statistics of jaws group among male and females in experiencing pain and suggest A strong correlation was found between pre- and post- large prospective studies with registry data including con- operative pain. Patients experiencing higher pre-operative founders to be done in the future [23, 24]. pain were more likely to experience long-term postopera- One of the major hurdles that a clinical study of this tive pain. Numerous causes for postoperative pain were nature faces is that pain is very subjective when coming to identified such as periapical pathosis, missed canals, inad - its evaluation and calculating pain is rather vague. In this equate cleaning, and shaping, inability to maintain apical regard designing of the questionnaire needs to be investi- patency during instrumentation, apical extrusion of debris, gated very carefully. It should be relatively straightforward irrigant, and intracanal medicament extrusion, overbite and easy for the patient to interpret [25]. Hence the reason restoration, and even the type of tooth [28]. The most for choosing VAS in this study was its reliability for pain common errors that are generally reported are missed ca- assessment [26]. nals, perforation, improper cleaning and shaping of com- Pain is multifactorial and numerous sensations contrib- plicated root canal anatomy, and ledge formation. ute towards postoperative pain making it extremely chal- Mild discomfort is a common complaint after endodon- lenging to associate all the possible causes of pain. The tic procedures but literature reports postoperative pain and highest level of post-endodontic pain reporting was ob- flare-up ranging from 3% - 58% [7]. Microbial, chemical, served 48-72 hours postoperatively [27]. and mechanical injuries are the leading cause of acute peri- 42 Acta Marisiensis - Seria Medica 2023;69(1) apical inflammation. Mechanical reasons can be attributed spirals of the Hyflex system are well known to unwind dur - to over-instrumentation, while chemical injuries include ing root canal preparation and were deformed around 80% extrusion of medicines, filling materials, or irrigants [7]. as reported in the study [30]. Regardless of how much care was taken to keep ev- Another study on Hyflex CM files showed a significant erything standardized, it is not possible to eliminate all decrease in cutting efficiency and flexibility after six steril - factors of pain and label it solely based on a single factor. ization cycles [39] [40]. In multiple rooted teeth, tissue debris along with bacte- Each Hyflex CM file can be used once in each canal as ria can persist due to the complex canal anatomy hence it unwinds and needs heat treatment to return to normal- good illumination and magnification with help of loupes cy. In our study since only single canal teeth were chosen or dental microscope are advised. Post-appointment soft hence each set of Hyflex CM files was used once per sam - tissue trauma causes a high level of discomfort at times ple up to six different times with each time being sterilized. due to local anesthesia administration or rubber dam No file separation occurred throughout the testing of placement. our study. All Hyflex CM NiTi rotary files continued to The patients in our study did not report any compli - prepare the canal without exceeding the torque control cations like swelling or paraesthesia and utmost care was limiter value, and all files returned to their original shape given to provide an atraumatic treatment protocol [27]. after each sterilization cycle. This is similar to research by No intracanal medication was used in our study al- Thompson et al. [41], which showed no significant differ - though it can reduce postoperative pain. Chlorhexidine ence in Hyflex CM NiTi files’ ability to maintain original alone and Chlorhexidine and CaOH reduce post-opera- canal curvature through 3 uses in resin blocks. It is, there- tive pain compared to no intracanal dressings between ap- fore, necessary for the clinician to be aware of different pointments [28]. variables present during clinical use when determining the A possible cause of flare-up is apical extrusion of den - ability of an instrument that can be reused for subsequent tinal mud. instrumentation after sterilization, as statistical significance It has been reported that the chances of apical extrusion may or may not directly correlate to clinical significance. increase with the increase in the diameter of the apical fo- Extrusion of irrigants can also be a leading cause of ramen [29] [30]. Which depends upon the selection of the post-instrumentation pain. A study was conducted that final apical size of the instrument  [31], instrumentation analyzed that side vented needles extruded less irrigant techniques, designs of instruments, the rotation speed of compared to the regular needles. Pressure applied during the file, and movements of the hand of the operator during irrigation can be standardized by the use of a device that preparation [32]. provides a constant flow rate as the operator handling ir - Other factors that could affect the extrusion of debris rigation procedure can even differ [42]. Different methods include root dentin hardness [33], quantity and momen- of irrigation delivery can be used which include manual tum of flow of the irrigation in the root canal [34, 35], and positive pressure irrigation, Endovac negative pressure ir- the position of the tooth whether in the upper or lower rigation, ultrasonic activation (Endoactivator), photon- jaw, which may be affected by the gravity. induced photo-acoustic streaming (PIPS), and Rinsendo. Studies demonstrate rotary NiTi systems with continu- Among these all, Endovac and Endoactivator did the ous rotation method, compared to reciproc file system, to least amount of irrigant extrusion [43-45]. Different NaO - be associated with less apical extrusion. The reason is due Cl concentrations have been reported to affect the bio - to the pitch design of the file, forward kinematics which logical properties. The higher the concentration of NaOCl forces debris in a coronal direction instead of apical extru- (1.3% and 5.25%) the most long-lasting, adverse reactions sion [36]. were noted in comparison to the ones with lower concen- Numerous studies have been published comparing dif- tration. Periapical extrusion was noted with higher concen- ferent file systems for apical debris extrusion. In a research tration causing more clinical manifestations [46]. reciprocating file system like Wave One Gold and continu - In the current study, the effect of two different types ous rotating ProTaper universal rotary instruments pro- of instrumentation techniques on post-operative pain was duced significantly more debris compared to Hyflex CM evaluated at 3 different time intervals. From scoring to rotary instruments [37]. treatment protocol everything was kept as standardized as In another in vitro study ProTaper Universal and Hyflex possible with a single clinician preparing for both groups. systems extruded more debris apically compared to ProTa- This study shows no significant pain difference using hand per Next and Twisted File Adaptive system [38]. K-file system or rotary Hyflex CM file system. Therefore it Elmsallati et al. compared rotary instruments with dif- can be safe to say that Hyflex CM file system can be used ferent short, medium, and large pitch designs for apical without the fear of eliciting any post instrumentation pain extrusion of the debris. It was concluded that short pitch to the patient. This system will not only help clear more design extruded less debris compared to medium and large. debris, adequately clean canal anatomy by maintaining The reason noted with Hyflex files for increased debris ex - original canal curvature but also save chair-side time with trusion was the unwinding feature of the instrument. The decrease in patient’s visits to the dentist [47-52]. Acta Marisiensis - Seria Medica 2023;69(1) 43 after root canal treatment: a systematic review. Journal of endodontics. Conclusion 2011;37(4):429-38. In conclusion, the incidence of postoperative pain in 2 12. Shibu TM. Post operative pain in endodontics: A systemic review. Journal different types of instrumentation systems assessed in of Dentistry and Oral Hygiene. 2015;7(8):130-7. 13. Alsulaimani RS, Al-Manei K, Baras B, Alaqeely R, El Metwally A, Ashri this study had no significant difference at 12, 24, and 48 N. Students’ perception of multiple dental visits for root canal treatment: hours (0.127, 0.867, and 0.846 respectively). No signifi - Questionnaire-based study. Saudi Endodontic Journal. 2016;6(1):21. 14. Govindaraju L, Jeevanandan G, Subramanian E. Comparison of quality cant difference was found between the different genders of obturation and instrumentation time using hand files and two rotary file or between the maxillary or mandibular jaw. However, a systems in primary molars: A single-blinded randomized controlled trial. significant difference was observed in initial preoperative European journal of dentistry. 2017;11(03):376-9. 15. Ochoa-Romero T, Mendez-Gonzalez V, Flores-Reyes H, Pozos-Guillen pain VAS in conventional files compared to Hyflex CM A. Comparison between rotary and manual techniques on duration of group (P=0.004). instrumentation and obturation times in primary teeth. Journal of Clinical Pediatric Dentistry. 2011;35(4):359-64. Therefore, the null hypothesis was accepted according to 16. Sonntag D, Guntermann A, Kim S, Stachniss V. Root canal shaping with the conditions established for this study, there was no sta- manual stainless steel files and rotary Ni-Ti files performed by students. tistically significant difference among the different instru - International endodontic journal. 2003;36(4):246-55. 17. Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, mentation systems in causing post-instrumentation pain. Moreno MR, et al. Validation of digital visual analog scale pain scoring with a traditional paper-based visual analog scale in adults. Journal of the Authors’ contribution American Academy of Orthopaedic Surgeons Global research & reviews. 2018;2(3). SaS (Conceptualization; Data curation; Resources; Project 18. Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge administration; Formal analysis; Supervision; Writing – JH, et al. Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a original draft & Writing – review & editing ) systematic literature review. Journal of pain and symptom management. NS (Formal analysis; Data curation; Investigation; Meth- 2011;41(6):1073-93. odology; Resources ) 19. Cicek E, Kocak MM, Kocak S, Sağlam BC, Türker SA. Postoperative pain intensity after using different instrumentation techniques: a randomized MA (Data curation; Methodology) clinical study. Journal of Applied Oral Science. 2017;25:20-6. ShS (Data curation; Methodology) 20. Al-Negrish ARS, Habahbeh R. Flare up rate related to root canal treatment of asymptomatic pulpally necrotic central incisor teeth in patients MP (Supervision; Writing– original draft; Validation; Vis- attending a military hospital. Journal of dentistry. 2006;34(9):635-40. ualization) 21. Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. 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Comparison of Journal of endodontics. 2014;40(6):867-70. cleaning efficacy and instrumentation time between rotary and manual instrumentation techniques in primary teeth: an in vitro study. International 42. Altundasar E, Nagas E, Uyanik O, Serper A. Debris and irrigant extrusion Journal of Clinical Pediatric Dentistry. 2016;9(2):124. potential of 2 rotary systems and irrigation needles. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology. 51. Saber S, Nagy M, Schäfer E. Comparative evaluation of the shaping 2011;112(4):e31-e5. ability of ProTaper Next, iRaC e and Hyflex CM rotary NiTi files in severely curved root canals. International endodontic journal. 2015;48(2):131-6. 43. Yost RA, Bergeron BE, Kirkpatrick TC, Roberts MD, Roberts HW, Himel VT, et al. Evaluation of 4 different irrigating systems for apical extrusion of 52. Bürklein S, Börjes L, Schäfer E. Comparison of preparation of curved root sodium hypochlorite. Journal of endodontics. 2015;41(9):1530-4. canals with H yflex CM and R evo-S rotary nickel–titanium instruments. International endodontic journal. 2014;47(5):470-6. 44. Desai P, Himel V. Comparative safety of various intracanal irrigation http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Acta Marisiensis - Seria Medica de Gruyter

Comparison of two different file systems on postoperative pain after root canal instrumentation: A randomized controlled trial

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Acta Marisiensis - Seria Medica 2023;69(1):37-44 DOI: 10.2478/amma-2023-0006 RESEARCH ARTICLE Comparison of two different file systems on postoperative pain after root canal instrumentation: A randomized controlled trial 1* 2 1 3 4 Saad Shahnawaz , Nabiya Shahroz , Muhammad Ahmed Zafar , Shahroz Sajjad , Mehwish Pasha , Arfa Sabir Hussain 1. Operative and Endodontic Department Islamic International Dental Hospital, Islamabad, Pakistan 2. Operative and Endodontic Department Shifa international hospital, Islamabad, Pakistan 3. Operative and Endodontic Department Armed Forces Institute of Dentistry, Islamabad, Pakistan 4. Dental materials Department, Shifa international hospital, Islamabad, Pakistan Introduction: In this study post instrumentation pain is evaluated between rotary hyflex CM files and conventional k-files at different time intervals. Methodology: fifty patients were equally assigned into two groups and instrumented using hyflex cm or conventional files. VAS for pain was noted before the start of a root canal and after the procedure at 12, 24, and 48 hours. Results: There was no significant difference at 12, 24, and 48 hours with P values being 0.127, 0.867, and 0.846 respectively. Conclusion: There is no significant difference in causing post-instrumentation pain between hyflex CM and conventional files at different time intervals. However, when accessing preop pain of the conventional file group, it had more pain mean score compared to hyflex group. According to this study, Conventional files may be able to slightly decrease the chances of post-instrumentation pain more than hyflex CM instrumentation. Keywords: hyflex CM, post instrumentation, conventional files, VAS Received 13 December 2022 / Accepted 6 February 2023 Introduction debris, irrigant or filling material [6, 7]. One of the integral The success of endodontic treatment depends upon proper part of endodontic treatment is prevention and manage- root canal instrumentation, debridement, disinfection, and ment of this post endodontic pain. According to studies three-dimensional apical seal to coronal seal [1]. However reported, frequency of post endodontic pain may range certain canal morphologies, preparation techniques, and from 16% to 50% in endodontic cases [8]. armamentarium may pose a challenge in achieving these Pain may occur after root canal preparation due to re- goals. Due to the vast complexity of endodontic factors, maining endodontic microbiota within the canal system there has been a huge advancement in the instrumentation and the extrusion of dentinal debris beyond the apex [9]. system. The introduction of the Nickel-titanium rotary Root canal treatment can be done in single or multiple systems has brought a paradigm shift in endodontics due visits. It has been shown that patients prefer single-visit to its ability to respect the canal curvature and morphol- treatment due to decreased number of operative visits, less ogy [2, 3]. time-consuming, and more economical [1, 10, 11]. The initially introduced rotary file systems brought the Post-instrumentation pain presents as a common find - challenge of file breakage, ledge formation, and perfora - ing, the dentist should not get worried and not immedi- tions. Further advancement in these systems lead to the ately initiate retreatment or extraction [12]. Also patients development of a ‘controlled memory file’ (Hyflex CM should be made aware of post-instrumentation pain and coltene) [4]. This file was made by CM wire which had the analgesic medication prescribed accordingly. This not only property to attain the shape of the curved canal even when encourages an anxious patient for treatment but provides out of the canal [5]. This six-file system had the advantage the dentist with the patient’s compliance, cooperation, of having high fatigue resistance and drastically reducing confidence and increases the dentist’s rapport [13]. The the chances of ledge formation, transportation, and perfo- shift from hand instrumentation to rotary systems has led rations, especially in curved canals. to better cleaning and shaping of canal anatomy in less Post-operative pain is the most frequent complication time duration, which has made rotary instrumentation a that is encountered during root canal treatment which can desired preference among patients and dentists [14-16]. be due to insufficient root canal preparation, debris or in - This study therefore aims to clinically compare single visit tracanal medicaments, presence of preoperative pain, peri- post instrumentation pain between rotary file system Hy - apical pathosis, canal apical patency and apical extrusion of flex CM and conventional hand K-file system and their possible impact on pain. * Correspondence to: Saad Shahnawaz E-mail: saadahmed552@hotmail.com 38 Acta Marisiensis - Seria Medica 2023;69(1) Materials and Method Group 1 was assigned preparation with the rotary file This randomized control trial research was conducted in system Hyflex CM (Coltene, Switzerland) while group 2 the accordance with the Declaration of Helsinki and by was prepared using conventional stainless-steel files (Mani, the regulations of the ethics committee of the Operative Japan). Each group consists of 25 participants. and Endodontic Department of Islamic International For group 1, the glide path was made using a conven- Dental hospital (Ref # 2021/007/007). The duration of tional hand file up to size 20 k-file. Followed by sequential study took approximately 12 months and was conducted canal preparation was initiated using Hyflex CM files as by a single operator. A total of 50 sample size patients were per the color coding red 0.08 taper (08/25), yellow 0.04 taken and divided into two groups giving 25 participants taper (04/20), red 0.04 taper (04/25), yellow 0.06 taper in each group. The sample size was decided using the Ope- (06/20) and lastly 0.30 tip diameter blue color-coded file nEpi sample size calculator keeping a confidence level of with 0.04 taper (04/30). 95%, with sample size (n) being 50. Copious irrigation between each file was done using The study was conducted between two different systems 5.25% NaOCl (Sodium Hypochlorite) with an irrigation that are the conventional hand K-file vs the Rotary file sys - needle (27gauge pulpdent double-sided vent) as deep with- tem Hyflex CM. The patients’ inclusion criteria were as in the canal as possible but within a range of less than 2mm follows: from the working length. Final irrigation with 5ml 5.25% – Permanent mature teeth having single roots. NaOCl, 5 ml 17% EDTA, and 5ml 2% Chlorhexidine – The age limit of the patient should ideally be between was done. 5ml distilled water was used following each ir- 20-60 years of age. rigation to avoid interaction of irrigants with each other – Initially, before treatment, the patient should fall in forming insoluble precipitates like para-chloroaniline [19]. the Visual Analogue Scale (VAS) “5” or more pre- The tooth was sealed by a temporary restorative material operatively. cavit (3M) till the next visit. – The tooth should be tender to percussion. For group 2, sequential stainless steel hand K-files up – Patients should have been diagnosed with Apical Pe- to size 30 were used, respecting the working length of the riodontitis and pulpal diagnosis should be irreversible canal, with the same irrigation protocol and temporary res- pulpitis or necrotic pulp. toration placed as mentioned above. – Patient with a necrotic tooth. Preoperative Pain and Pain after 12, 24, and 48 hours The exclusion criteria were as follows: were assessed by VAS for both groups. The patient was – Unrestorable grossly carious teeth, Perforated teeth contacted by the clinical assistant via telephone after 12, with poor prognosis, or broken-down roots. 24, and 48 hours to provide relevant information regard- – Patient self-medicating or taking prescribed antibio- ing pain rating. In the case of VAS being recorded above 9, tics or analgesics. analgesics were prescribed. – Teeth with any sort of complexity like dilaceration, or After 48 hours of data collection, patients were called internal or external root resorption. back for obturation with Gutta Percha cones of the respec- – Teeth with previously endodontic treatment. tive system and AH plus sealer (Dentsply, Sirona, USA) – Teeth with multiple roots. using the cold lateral condensation technique. Treatment – Teeth associated with draining abscess or sinus tract. was concluded by sealing the coronal access cavity with – Patients who had uncontrolled systemic diseases. dental adhesive and composite resin (3M Filtek Universal Patients were referred to the Operative and Endodontic composite, USA) [5]. Department. The pulpal and the apical diagnosis were con - firmed by the operator with the help of periapical digital Statistical analysis radiographic evaluation, periodontal evaluation, percus- Data analysis was done using Statistical Package sion, and use of the pulp tester. The treatment protocol for Social Sciences (IBM®  SPSS®  Statistics devel- was explained to the patient and an informed written oped by Norman H. Nie, Dale H. Bent, C. Hadlai consent form was signed for ethical consideration. VAS Hull, version 25, Chicago, USA). Descriptive statis- was presented as a numerical rating scale to the patient tics were expressed as mean and standard deviation. numbered from 0-10. The patient was explained pain Frequencies and mean VAS were calculated for each group intensity from “0” to be none and gradually increasing and tested for significance with Mann Whitney U test. The towards severe pain at a score of “10”. While score of effect of age and gender on VAS between the two groups is “5” being as moderate pain [17, 18]. also calculated using Mann Whitney U test. VAS was noted before the treatment. Patients were ran- domly assigned into two groups. Local anesthesia (Medic- Results aine, Korea) was administered and consisted of 2% lido- Patients enrolled in the clinical trial are shown in the fol- caine with epinephrine 1:100,000, and a rubber dam was lowing flow diagram in Figure 1. applied. Access opening and single visit canal preparation Demographic data are shown in Table 1, Table 2, and were done. Figure 2. Among the total participants of study 64% were CONSORT Flow Diagram Acta Marisiensis - Seria Medica 2023;69(1) 39 Assessed for eligibility (n=51) Enrollment Excluded (n=0)  Not meeting inclusion criteria (n=1)  Declined to participate (n=0)  Other reasons (n=0) Randomized (n=50) Allocation Allocated to intervention (n=25) Allocated to intervention (n=25)  Received allocated intervention (n=25)  Received allocated intervention (n=25)  Did not receive allocated intervention (give  Did not receive allocated intervention (give reasons) (n=0) reasons) (n=0) Follow-Up Lost to follow-up (give reasons) (n=0) Lost to follow-up (give reasons) (n=0) Discontinued intervention (give reasons) (n=0) Discontinued intervention (give reasons) (n=0) Analysis Analysed (n=25) Analysed (n=25)  Excluded from analysis (give reasons) (n=0)  Excluded from analysis (give reasons) (n=0) Fig. 1. Consort flow diagram Table1. Gender distribution in both groups gender Total male female Control hand K-files 12 13 25 group Hyflex CM 6 19 25 Total 18 32 50 Table 2. Jaw frequency in both groups maxilla mandible Total group Control hand K-files 14 11 25 Hyflex CM 14 11 25 Total 28 22 50 Fig. 2. Gender frequency in both groups 40 Acta Marisiensis - Seria Medica 2023;69(1) female and 36% were male. Also a total of 56% maxillary Among all the mean statistical values between the con- teeth were included in study and remaining 44% mandib- trol group and Hyflex CM group, genders group and jaws ular teeth. No significant difference was observed in caus - group, the similarity of decreasing pain is visible when ing post instrumentation pain between conventional K-file viewed on bar graph through 12,24 and 48 hour time pe- and Hyflex CM file system at 12, 24, and 48 hours (P riod. This can be seen in figure 3, 4 and 5 respectively. value 0.127,0.867,0.846 respectively) Table 3. Although a significant difference was observed in preop pain VAS in Discussion the conventional file group compared to Hyflex CM group In our study no significant difference was observed in post- (P=0.004). (Table 3) instrumentation pain among genders and jaws. Although When gender groups were analyzed no significant dif - the bar graph shows slightly more pain prevalence among ference was observed between the two groups at 12, 24, female patients but this could be due to more number of and 48 hours (P value 0.705, 0.172, 0.344 respectively) as female participants (64%) compared to males (34%) as shown in Table 4. shown in Figure D in this study. Other studies have shown On jaw analyses also no significant difference was ob - pain to be more prevalent among females compared to served between the two groups at 12, 24, and 48 hours (P males [20-22].These results could be due to higher num - value 0.579. 0.266, 0.696 respectively) as shown in Table ber of sample size taken by these studies which our study 5. lacked. While some studies show no relevant difference Table 3. Correlation between the two groups preo op pain VAS 12 hour VAS 24 hour VAS 48 hour VAS Mann-Whitney U 164.500 235.000 304.000 303.000 Wilcoxon W 489.500 560.000 629.000 628.000 Z -2.915 -1.525 -.168 -.194 Asymp. Sig. (2-tailed) .004 .127 .867 .846 Table 4. Correlation between the two genders preo op pain VAS 12 hour VAS 24 hour VAS 48 hour VAS Mann-Whitney U 207.000 269.500 221.500 243.500 Wilcoxon W 735.000 797.500 392.500 414.500 Z -1.662 -.379 -1.365 -.947 Asymp. Sig. (2-tailed) .096 .705 .172 .344 Table 5. Correlation between jaws preo op pain VAS 12 hour VAS 24 hour VAS 48 hour VAS Mann-Whitney U 306.500 280.000 252.000 289.000 Wilcoxon W 559.500 533.000 505.000 542.000 Z -.030 -.555 -1.112 -.391 Asymp. Sig. (2-tailed) .976 .579 .266 .696 Fig. 3. Bar graph for mean statistics of manual group and Hyflex CM group Acta Marisiensis - Seria Medica 2023;69(1) 41 Fig. 4. Bar graph for mean statistics of gender group Fig. 5. Bar graph for mean statistics of jaws group among male and females in experiencing pain and suggest A strong correlation was found between pre- and post- large prospective studies with registry data including con- operative pain. Patients experiencing higher pre-operative founders to be done in the future [23, 24]. pain were more likely to experience long-term postopera- One of the major hurdles that a clinical study of this tive pain. Numerous causes for postoperative pain were nature faces is that pain is very subjective when coming to identified such as periapical pathosis, missed canals, inad - its evaluation and calculating pain is rather vague. In this equate cleaning, and shaping, inability to maintain apical regard designing of the questionnaire needs to be investi- patency during instrumentation, apical extrusion of debris, gated very carefully. It should be relatively straightforward irrigant, and intracanal medicament extrusion, overbite and easy for the patient to interpret [25]. Hence the reason restoration, and even the type of tooth [28]. The most for choosing VAS in this study was its reliability for pain common errors that are generally reported are missed ca- assessment [26]. nals, perforation, improper cleaning and shaping of com- Pain is multifactorial and numerous sensations contrib- plicated root canal anatomy, and ledge formation. ute towards postoperative pain making it extremely chal- Mild discomfort is a common complaint after endodon- lenging to associate all the possible causes of pain. The tic procedures but literature reports postoperative pain and highest level of post-endodontic pain reporting was ob- flare-up ranging from 3% - 58% [7]. Microbial, chemical, served 48-72 hours postoperatively [27]. and mechanical injuries are the leading cause of acute peri- 42 Acta Marisiensis - Seria Medica 2023;69(1) apical inflammation. Mechanical reasons can be attributed spirals of the Hyflex system are well known to unwind dur - to over-instrumentation, while chemical injuries include ing root canal preparation and were deformed around 80% extrusion of medicines, filling materials, or irrigants [7]. as reported in the study [30]. Regardless of how much care was taken to keep ev- Another study on Hyflex CM files showed a significant erything standardized, it is not possible to eliminate all decrease in cutting efficiency and flexibility after six steril - factors of pain and label it solely based on a single factor. ization cycles [39] [40]. In multiple rooted teeth, tissue debris along with bacte- Each Hyflex CM file can be used once in each canal as ria can persist due to the complex canal anatomy hence it unwinds and needs heat treatment to return to normal- good illumination and magnification with help of loupes cy. In our study since only single canal teeth were chosen or dental microscope are advised. Post-appointment soft hence each set of Hyflex CM files was used once per sam - tissue trauma causes a high level of discomfort at times ple up to six different times with each time being sterilized. due to local anesthesia administration or rubber dam No file separation occurred throughout the testing of placement. our study. All Hyflex CM NiTi rotary files continued to The patients in our study did not report any compli - prepare the canal without exceeding the torque control cations like swelling or paraesthesia and utmost care was limiter value, and all files returned to their original shape given to provide an atraumatic treatment protocol [27]. after each sterilization cycle. This is similar to research by No intracanal medication was used in our study al- Thompson et al. [41], which showed no significant differ - though it can reduce postoperative pain. Chlorhexidine ence in Hyflex CM NiTi files’ ability to maintain original alone and Chlorhexidine and CaOH reduce post-opera- canal curvature through 3 uses in resin blocks. It is, there- tive pain compared to no intracanal dressings between ap- fore, necessary for the clinician to be aware of different pointments [28]. variables present during clinical use when determining the A possible cause of flare-up is apical extrusion of den - ability of an instrument that can be reused for subsequent tinal mud. instrumentation after sterilization, as statistical significance It has been reported that the chances of apical extrusion may or may not directly correlate to clinical significance. increase with the increase in the diameter of the apical fo- Extrusion of irrigants can also be a leading cause of ramen [29] [30]. Which depends upon the selection of the post-instrumentation pain. A study was conducted that final apical size of the instrument  [31], instrumentation analyzed that side vented needles extruded less irrigant techniques, designs of instruments, the rotation speed of compared to the regular needles. Pressure applied during the file, and movements of the hand of the operator during irrigation can be standardized by the use of a device that preparation [32]. provides a constant flow rate as the operator handling ir - Other factors that could affect the extrusion of debris rigation procedure can even differ [42]. Different methods include root dentin hardness [33], quantity and momen- of irrigation delivery can be used which include manual tum of flow of the irrigation in the root canal [34, 35], and positive pressure irrigation, Endovac negative pressure ir- the position of the tooth whether in the upper or lower rigation, ultrasonic activation (Endoactivator), photon- jaw, which may be affected by the gravity. induced photo-acoustic streaming (PIPS), and Rinsendo. Studies demonstrate rotary NiTi systems with continu- Among these all, Endovac and Endoactivator did the ous rotation method, compared to reciproc file system, to least amount of irrigant extrusion [43-45]. Different NaO - be associated with less apical extrusion. The reason is due Cl concentrations have been reported to affect the bio - to the pitch design of the file, forward kinematics which logical properties. The higher the concentration of NaOCl forces debris in a coronal direction instead of apical extru- (1.3% and 5.25%) the most long-lasting, adverse reactions sion [36]. were noted in comparison to the ones with lower concen- Numerous studies have been published comparing dif- tration. Periapical extrusion was noted with higher concen- ferent file systems for apical debris extrusion. In a research tration causing more clinical manifestations [46]. reciprocating file system like Wave One Gold and continu - In the current study, the effect of two different types ous rotating ProTaper universal rotary instruments pro- of instrumentation techniques on post-operative pain was duced significantly more debris compared to Hyflex CM evaluated at 3 different time intervals. From scoring to rotary instruments [37]. treatment protocol everything was kept as standardized as In another in vitro study ProTaper Universal and Hyflex possible with a single clinician preparing for both groups. systems extruded more debris apically compared to ProTa- This study shows no significant pain difference using hand per Next and Twisted File Adaptive system [38]. K-file system or rotary Hyflex CM file system. Therefore it Elmsallati et al. compared rotary instruments with dif- can be safe to say that Hyflex CM file system can be used ferent short, medium, and large pitch designs for apical without the fear of eliciting any post instrumentation pain extrusion of the debris. It was concluded that short pitch to the patient. This system will not only help clear more design extruded less debris compared to medium and large. debris, adequately clean canal anatomy by maintaining The reason noted with Hyflex files for increased debris ex - original canal curvature but also save chair-side time with trusion was the unwinding feature of the instrument. The decrease in patient’s visits to the dentist [47-52]. Acta Marisiensis - Seria Medica 2023;69(1) 43 after root canal treatment: a systematic review. Journal of endodontics. Conclusion 2011;37(4):429-38. In conclusion, the incidence of postoperative pain in 2 12. Shibu TM. Post operative pain in endodontics: A systemic review. Journal different types of instrumentation systems assessed in of Dentistry and Oral Hygiene. 2015;7(8):130-7. 13. Alsulaimani RS, Al-Manei K, Baras B, Alaqeely R, El Metwally A, Ashri this study had no significant difference at 12, 24, and 48 N. 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Journal

Acta Marisiensis - Seria Medica – de Gruyter

Published: Mar 1, 2023

Keywords: hyflex CM; post instrumentation; conventional files; VAS

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