|Year : 2022 | Volume
| Issue : 1 | Page : 32-40
Determination of clinical efficiency of pediatric rotary file systems for root canal preparation in primary molars - A comparative study
K L Girish Babu1, G Kavyashree1, Geeta Maruti Doddamani2
1 Department of Dentistry, Hassan Institute of Medical Sciences, Hassan, Karnataka, India
2 Dr. Syamala Reddy Dental College Hospital and Research Centre, Bengaluru, Karnataka, India
|Date of Submission||02-Oct-2021|
|Date of Decision||31-Oct-2021|
|Date of Acceptance||17-Nov-2021|
|Date of Web Publication||29-Apr-2022|
Dr. K L Girish Babu
Department of Dentistry, Hassan Institute of Medical Sciences, Hassan - 573 201, Karnataka
Source of Support: None, Conflict of Interest: None
Introduction: To meet the demand of pediatric endodontists, exclusive pediatric rotary file systems have been recently introduced by the manufactures. However, no study has been conducted to compare the clinical efficiency between pediatric rotary file systems.
Aim: To determine the clinical efficiency (instrumentation time, obturation time, quality of obturation and postoperative pain) of two pediatric rotary file systems following the root canal preparation of primary molars.
Materials and Methods: A total of 75 primary molars requiring pulpectomy were selected from children aged 4 to 7 years. These teeth were divided into three groups of 25 teeth each. In the first, second, and third groups, the cleaning and shaping of the root canals were carried out with Pedo-Flex pediatric rotary files (Group PF), Kedo-S pediatric rotary files (Group KS), and, manual nickel-titanium K-files (Group MF), respectively. Obturation was carried out with zinc oxide eugenol cement with an engine-driven Lentulo spiral. The instrumentation and obturation times were recorded. The quality of the root filling was radiographically assessed immediately after obturation. The postoperative pain was evaluated at time intervals of 6, 12, 24, 48, 72 h, and 1 week.
Results and Discussion: The instrumentation and obturation times were significantly less with the use of pediatric rotary file systems compared to the manual file system. The quality of obturation was superior in the root canals instrumented with pediatric rotary file systems compared to manual files. There was decreased postoperative pain with the use of pediatric rotary file systems as compared to manual files. In all three groups, postoperative pain decreased over time. The optimally filled root canals showed a significant correlation with the absence of postoperative pain.
Conclusions: The use of pediatric rotary file systems for root canal instrumentation of primary molars resulted in the superior quality of obturation in decreased instrumentation and obturating times with the least postoperative pain. The overfilled root canals were not associated with significant postoperative pain.
Keywords: Obturation, postoperative pain, pulpectomy, rotary files
|How to cite this article:|
Babu K L, Kavyashree G, Doddamani GM. Determination of clinical efficiency of pediatric rotary file systems for root canal preparation in primary molars - A comparative study. Saudi J Oral Sci 2022;9:32-40
|How to cite this URL:|
Babu K L, Kavyashree G, Doddamani GM. Determination of clinical efficiency of pediatric rotary file systems for root canal preparation in primary molars - A comparative study. Saudi J Oral Sci [serial online] 2022 [cited 2022 Sep 28];9:32-40. Available from: https://www.saudijos.org/text.asp?2022/9/1/32/344402
| Introduction|| |
A pulpectomy is carried out when inflammation of the pulpal tissue extends up to the radicular pulp or nonvital pulp tissue or exposure of pulp tissue due to traumatic injuries. The procedure consists of complete removal of the inflamed and infected pulp tissue along with debris from the root canal followed by instrumentation of the root canals and finally obturating with an antimicrobial, resorbable paste to ensure a three-dimensional seal so that recurrence of bacterial infection is prevented., The endodontic treatment of deciduous teeth is more challenging due to the anatomical variations of their root canal systems and their proximity to the developing permanent tooth, added with the difficulty of management of children behavior.,
Routinely instrumentation of the primary root canal has been carried out using the manual file system. The use of this file system is time-consuming and may lead to iatrogenic errors., The development of nickel–titanium (Ni-Ti) instruments brought a change in the traditional design and taper of the files which led to the introduction of rotary endodontics. Barr et al. were the first to use the rotary instruments in pediatric endodontics and stated that the use of rotary files results in superior and uniform obturation in primary teeth., Since then many rotary endodontic systems have been recommended for instrumentation of root canals of primary teeth.,,,, However, Ni-Ti file systems are primarily manufactured for use in permanent teeth. The use of these files in primary teeth may lead to lateral perforations, as primary teeth have shorter, thinner curved roots compared to permanent teeth and a ribbon-shaped morphology.,
To meet the demand of pediatric endodontists, exclusive pediatric rotary file systems have been recently introduced by the manufactures. Independent studies have been reported superior clinical efficiency of the pediatric rotary file systems compared to manual files.,,,,,, However, no study has been conducted to compare the clinical efficiency of pediatric rotary file systems. Therefore, the purpose of this study was to determine the clinical efficiency of two pediatric rotary file systems with that of a manual file system for root canal preparation of primary molars. The objectives were to evaluate and compare the instrumentation time, obturation time, quality of obturation and, postoperative pain following the root canal preparation of primary molars with two pediatric rotary file systems and a manual file system.
| Methods|| |
Ethical clearance was obtained from our institutional review board to conduct this study. The study protocol followed the guidelines provided by the World Medical Association's Declaration of Helsinki on Ethical Principles for Medical Research. The CONSORT guidelines for planning and reporting clinical trials in pediatric endodontics were followed throughout the different stages of the study [Figure 1]. The sample size was calculated considering the previously published studies,,,,,, with 95% power using G Power analysis. The estimated sample size was 22; this was rounded off to 25.
The study sample included normal, healthy, and cooperative children aged 4 to 7 years. Seventy-five primary molars indicated for pulpectomy were selected from these children. The study objectives and procedure protocol were explained to the parents or caretakers of the participating children. Informed, written consent was taken from the parents who agreed to be part of the study. Identification numbers were given to each participating child to maintain confidentiality and their records were maintained by the principal investigator alone. Intraoral examinations were performed and standardized intraoral periapical radiographs were taken for the teeth with the possible indication for pulpectomy. Primary molars with necrotic pulp, sinus tract, irreversible pulpitis symptoms, radiolucent areas in furcation or periapical region, and had at-least two-thirds of each root remaining were included., Primary molars with structures inadequate for restoration, perforated pulpal floor, swelling (intraoral or extraoral), and excessive mobility were excluded., In addition, children requiring special health care needs, had limited or lacking cooperative abilities, or required sedation/general anesthesia for behavior management was not included.,
Computer-generated randomization was used to allocate the selected teeth into three groups, consisting of 25 teeth each, according to the type of instrumentation to be used for root canal preparation. In the first, second, and third groups, the cleaning and shaping of the root canals were carried out with Pedo-Flex pediatric rotary files (Waldent Innovation Pvt Ltd)-Group PF, Kedo-S pediatric rotary files (Reeganz Dental Care Pvt. Ltd., India)-Group KS and, manual NiTi K-files (Dentsply, Switzerland)-Group MF, respectively. Under stringent aseptic conditions, the pulpectomy was performed by a single pediatric dentist having adequate knowledge of rotary and hand instrumentation techniques.
Following the administration of local anesthesia (2% lignocaine, Lignox, Bangalore, India), for the tooth indicated, dental caries and overhanging enamel were removed with a #330 high-speed bur under a water spray. The coronal pulp was accessed using a #8 round bur, and the entire roof of the pulp chamber was removed. Necrotic tissue was removed from the pulp chamber with a sterile sharp spoon excavator (2 mm, EXC31W, #41 Round, 31W Endo Excavators, Hu-Friedy Mfg. Co., LLC). The straight-line access was obtained and pulp tissue was extirpated from the root canal using H-files (Mani, Inc., Tochigi, Japan) The patency of the root canal was assessed using a #10 K-file (Mani, Inc., Tochigi, Japan). The working length was determined by superimposing an endodontic instrument over the preoperative radiograph and keeping it 1–2 mm short of the radiographic apex.,
The root canals in Group PF were instrumented with the Pedo-Flex pediatric rotary file system according to the manufacturer's instructions. The root canals in Group KS were instrumented with the Kedo-S pediatric rotary file system. The D1 and E1 rotary files were used in mesial and distal root canals, respectively, with a lateral brushing motion. In both the groups (PF and KS), the root canals were first instrumented up to the coronal one-third using a coronal-enlarging file (Endoflare-Micromega, Geneva, Switzerland). Then, the root canals were enlarged to working length according to the sequence recommended by the manufacturer. The rotary file systems used for Groups PF and KS were operated with an endodontic motor (X-Smart, Dentsply Maillefer, OK, USA) at 300 rpm and 2.2-Ncm torque. To prevent unexpected lateral perforation, especially in severely curved root canals, the root canals were not entered more than twice with each rotary file. The root canals in Group MF were instrumented with manual NiTi K files. A minimum-size file provided resistance for intracanal placement until the working length was determined as an initial file. The root canals were enlarged up to three times the size of the initial file. Then, the root canals were cleaned and shaped using a pullback motion. In all three groups, each file was used on up to five teeth to maintain uniformity during root canal preparation., If a point of resistance was encountered, no attempt was made to go beyond it; this was ensured to lower the risk of instrument fracture. All of the root canals were prepared with intermittent irrigation using a standard 5-ml volume of normal saline.
To lubricate the root canal during root canal preparation, 17% Ethylenediaminetetraacetic acid gel (RC Help, Prime Dental Products, Pvt. Ltd.) was used. Following complete root canal preparation, final irrigation was carried out with saline, and the root canals were dried with absorbent paper points. In all three groups, the root canals of the primary molars were obturated with zinc oxide eugenol cement (Zinc Oxide BP, Eugenol BP, Associated Dental Products Ltd.) using a Lentulo spiral mounted on a slow-speed handpiece. The selected Lentulo spiral was one size smaller than the last-used file size and was cut to half its length with a pair of sharp scissors to facilitate handling. A homogenous mixture of zinc oxide eugenol was mixed in a powder: liquid ratio of 1:1. The prepared paste was carried into the root canal using a slow-speed handpiece rotating in a clockwise direction, which was then gently withdrawn from the root canal while still rotating. A rubber stopper was used to keep the Lentulo spiral 1 mm short of the working length. This process was repeated five to seven times for each root canal until the canal orifice was filled with the paste., The pulp chamber was cleaned with a moist cotton pellet and then restored with type II glass ionomer cement (GC, India)., The final restoration with stainless steel crowns (3M ESPE, St. Paul, MN, USA) was carried out in a second appointment within 1 week of obturation. All the participants were instructed to report any symptoms following the procedure, such as pain or swelling.
The instrumentation and obturation times were calculated by a trained dental nurse using a stopwatch. Instrumentation time is the amount of time required to negotiate and shape all the root canals of a tooth to the desired size after root canal access opening and working length determination. Obturation time is the amount of time required to obturate all the root canals of a tooth after instrumentation., Immediate postoperative intraoral radiographs were taken with a dental X-ray unit operating at 60 kvp, 6 mA, 0.3 seconds, and 15 mm. These radiographs were evaluated for quality of obturation by two pediatric dentists who were blinded to the type of instrumentation used. A kappa test was performed for these examiners, producing scores of 0.88 and 0.95 for the inter-examiner and the intra-examiner, respectively. The examiners graded each radiograph as underfilled, optimally filled, or overfilled., Whenever there was disagreement between examiners, a lower ranking was chosen.
A questionnaire was given to the children's parents to record the intensity of postoperative pain. Postoperative pain was recorded at six, 12, 24, 48, 72 h, and at 1 week following the pulpectomy. A nursing officer, blinded to the study groups, trained all the parents about recording the postoperative pain intensity scale. Postoperative pain was recorded according to the four-point pain intensity scale. This scale categorizes the pain as below: (1) Zero–no pain; (2) one–slight pain; (3) two–moderate pain; and (4) three–severe pain. To ensure standardization, the same parent was asked to record the pain intensity at all time intervals as told by the child. To ensure the chances of the parents being failed to record the pain at a given frame, findings were also recorded by the investigator through telephonic conversation with the parents. One week following the pulpectomy procedure, the children returned to the department with their completed questionnaire forms.
The participants, their parents, outcome assessors, and data analysts were blinded to the type of instrumentation used; however, the operator could not be blinded due to the recognizable characteristics of the rotary and manual files.
Statistical Package for Social Sciences (SPSS) for Windows Version 22.0 Released 2013. Armonk, NY, USA: IBM Corp. was used to perform statistical analyses. Descriptive analysis of all the explanatory and outcome parameters was done using frequency and proportions for categorical variables, whereas in mean and standard deviation for continuous variables. Inferential statistics: Chi-square test was used to compare the obturation quality scores and postoperative pain scores at different time intervals between 3 groups and to correlate them. The level of statistical significance was set at P ≤ 0.05.
| Results|| |
The mean age of the participating children was 5.87 ± 0.158 years. A total of 33 maxillary teeth and 42 mandibular teeth were treated by pulpectomy. The mean instrumentation time for Groups PF, KS, and MF was 12.16 ± 1.89 min, 13.96 ± 2.51 min, and 23.00 ± 3.08 min, respectively [Graph 1]. The mean difference of instrumentation time of Groups PF and KS was significant compared to Group MF. The mean obturation time for Group PF, KS, and MF was 7.18 ± 1.6 min, 7.83 ± 1.9 min, and 9.63 ± 15.61 min, respectively [Graph 1]. The mean difference between Groups PF and KS was not statistically significant. However, there was a significant difference when Groups PF and KS were compared with Group MF. In Group PF, 3 (12%) teeth were underfilled, 19 (76%) teeth were optimally filled, and 3 (12%) teeth were overfilled. In Group KS, 2 (8%) teeth were underfilled, 20 (76%) teeth were optimally filled, and 3 (12%) teeth were overfilled. In Group MF, 6 (24%) teeth were underfilled, 14 (56%) teeth were optimally filled, and 5 (20%) teeth were overfilled [Graph 2]. The quality of obturation was significantly superior in Groups PF and KS compared to Group MF. However, it did not significantly differ between Groups PF and KS.
The children experienced a significantly higher intensity of postoperative pain in group MF than in groups PF and KS at six, 12, 24, and 48 h. In all three groups, the highest postoperative pain scores were recorded at 6 h and it decreased over time. At 72 h of the interval of time, there was no significant difference in the postoperative pain between the three groups [Graph 3]. There was no statistically significant difference in postoperative pain scores between Groups PF and KS. No children reported severe pain, resulting in the use of analgesic, at any intervals of time.
The absence of postoperative pain was significantly correlated with the optimally filled root canals [Table 1]. In Group KS, a higher percentage of optimally filled root canals were not associated with postoperative pain, followed by Groups PF and MF. In Group MF, 20% of teeth had slight and moderate pain, in overfilled root canals. On comparison of postoperative pain scores between three groups for quality of obturation of score 3, the pain was not significant between the Groups PF and KS, but it was significant between the Groups PF and MF and the Groups KS and MF [Table 2].
|Table 1: Correlation of quality of obturation and postoperative pain scores between three groups|
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|Table 2: Multiple comparison of postoperative pain scores between three groups for quality of obturation of score 3|
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| Discussion|| |
To reduce the child's anxiety and to obtain maximum cooperation during pulpectomy, the decreased root canal instrumentation time is essential. The decreased root canal instrumentation time, apart from reducing patient and dentist fatigue, also allows for faster, safer, and improved quality treatment., A significant reduction in root canal instrumentation time was observed in both the pediatric rotary file systems compared to the manual file system. This finding is consistent with previous studies.,,,,,,, However, a relatively increased time was observed in our study compared to prior reports., As the participated children were of a younger age group, root canal instrumentation was carried out relatively slower to ensure maximum cooperation. In addition, the operator's knowledge level, skill, and experience with rotary endodontics would have influenced the root canal instrumentation time. The obturation time was reduced in the root canals instrumented with pediatric rotary file systems compared to those prepared with manual files. The rotary files prepare a relatively wide, conical root canal that enables the easy flow of obturating material. Further, the removal of cervical obstructions in the root canals with the use of Endoflare could have decreased the obturation time. The manual files prepare the root canal more irregularly, thus taking more time for obturation.,,,
The quality of obturation determines the success of pulpectomized teeth. We observed a greater number of optimally filled teeth that were instrumented with pediatric rotary file systems than manual files. The rotary file has an elastic memory and a radial land that keeps the file in the center of the root canal via wall support and inactive tips, resulting in a conical root canal shape than those produced by manual files.,, Additionally, rotary files debride the uneven walls of primary root canals more effectively. Further, pre-flaring of the coronal third of the root canal with Endoflare removes any cervical interference from the root canal entrances and allows endodontic instruments to freely access the apical portion of the root canal. All these factors along with the greater taper of the rotary files compared to manual files could have contributed to the dense, uniform, and superior quality of obturation.,, This observation is consistent with other studies.,,,,,,, Although the obturation materials and techniques varied between the cited studies and our study, the quality of obturation did not vary significantly.
The use of pediatric rotary file systems produced the least number of overfilled root canals. This may be because the rotary file systems produce minimal apical enlargement that prevents the over preparation and extrusion of the obturating material. The overfilling of root canals is unavoidable in some situations, as the dentinal wall of the root canal extending toward the succedaneous tooth is thin and weak and thus may give way during instrumentation. The reduction of control of tactile sensation of the operator during the use of rotary files, pre-existing peri-radicular pathology, physiological root resorption, and lack of apical constriction are the other contributing factors for overfilling.,,,, Additionally, the incorrect position of the rubber stopper fitted onto the Lentulo spiral could result in the overfilled root canals. Due to all these reasons, care should be taken while using rotary files. The use of lesser tapered manual files results in narrow irregular root canals, which prevent the adequate flow of obturating material., This may be the reason for the observation of a higher number of the underfilled root canal with the use of manual NiTi files in our study. This finding is consistent with the prior studies.,,,,,,,,,
There was no statistically significant difference in obturation quality between the primary molars instrumented with either of the pediatric rotary file systems. This result is consistent with prior studies that reported superior obturation quality with the use of a rotary file system in primary teeth, irrespective of the type of rotary file systems used.,,, In contrast; an Indian study reported an equal performance of rotary and manual files in terms of obturation quality.
The other factor that influences the success of pulpectomized teeth is postoperative pain. The probable reason for postoperative pain is the extrusion of foreign particles such as apical debris and obturating material into peri-radicular tissues irritating the periapical area resulting in inflammation and release of inflammatory mediators causing postoperative pain. The participated children treated with pediatric rotary file systems experienced significantly lesser postoperative pain compared to manual files. The rotary files work in rotational movements resulting in less apical debris compared to manual files causing less postoperative pain., The use of rotary file systems results in less apical debris because they are used in the crown-down technique, in which they enlarge the coronal third of the root canal directing the debris more coronally., The taper of the pediatric rotary file system limits the apical preparation of the root canal and provides a wider cervical preparation., This would have prevented over instrumentation thus limiting the debris extrusion in the apical third of the root canal. The use of manual files in piston-like motion causes an increased amount of apical debris resulting in increased postoperative pain.,, The reduced instrumentation time with the rotary file systems may be another reason for decreased postoperative pain., The variation observed in the intensity and duration of postoperative pain may be due to variation in the type of root canal instrumentation that influences the amount of extruded debris and neuropeptides released from C-fibres of the periodontal ligament. The time required for the effects of the anesthesia to completely dissipate is approximately 6 h after the treatment. This may be the reason for recording the greatest postoperative pain level following six hours in our study. A steady decrease in the postoperative pain was seen after 6 h and 12 h in children treated with rotary and manual file systems, respectively. This observation is consistent with the results of previous studies.,,, None of the participated children reported severe pain, resulting in the use of analgesic, at any intervals of time.
The correlation between the quality of obturation and postoperative pain showed a lesser postoperative pain in optimally filled canals prepared with pediatric rotary file systems than the manual file system. The overfilled root canals were not associated with significant postoperative pain. This may be due to (1) Lesser amount of apical debris with the use of rotary files (2) Lesser number of overfilled canals in teeth instrumented with rotary files and (3) The periapical tissues serve as a natural barrier against extrusion of debris resulting in decreased postoperative pain.
The results of the study indicate the use of rotary file systems than manual files during root canal instrumentation for the superior quality of obturation in decreased instrumentation and obturating time with least postoperative pain. It also recommends the use of either of the pediatric rotary file systems as they are operator's friendly due to their short file length, short working length, and variable tapers with variable tip diameters. Further, the operator can carry out the procedures more quickly and efficiently; thus reducing the anxiety of children and enhancing their behavior positively. However, the operator should improve their knowledge and skills about rotary endodontics as it is still new to the field of pediatric dentistry.
The assessment of quality of obturation using a two 2-dimensional radiographic image and a relatively small sample size are some of the potential limitations of this study. Future studies should use the 3-dimensional image (cone beam computed tomography) that will give a volumetric assessment of each root canal, and include variables that influence the postoperative pain like the tooth type, gender, preoperative pulpal diagnosis, and preoperative pain in a large sample size with a long-term follow-up to shed more light on the success of pulpectomized teeth.
| Conclusions|| |
The instrumentation and obturation time was significantly less with the use of pediatric rotary file systems compared to the manual file system. There was no significant difference in the instrumentation and obturation time in primary molars instrumented with either pediatric rotary file system. The quality of obturation in primary molars instrumented with pediatric rotary file systems was found to be superior to that of primary molars instrumented with a manual file system. There was no significant difference in the quality of obturation between primary molars instrumented with either pediatric rotary file system
Postoperative pain was found to be significantly less with instrumentation of pediatric rotary files as compared to manual files. There was no significant difference in the postoperative pain experienced between the two rotary file systems. The correlation between the quality of obturation and postoperative pain showed a lesser postoperative pain in optimally filled canals prepared with pediatric rotary file systems than the manual file system. The overfilled root canals were not associated with significant postoperative pain.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]