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This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
Pulpectomy is the treatment of choice for severely infected primary molars. The aim of the study is to evaluate the instrumentation time and obturation quality using Kedo SG blue, Kedo SH, and reciprocating hand K files in primary mandibular molars. To evaluate the instrumentation time and obturation quality using Kedo-SG blue, Kedo-SH, and reciprocating hand K-files in primary mandibular molars.
A double-blinded randomized controlled trial was conducted on 45 mandibular molars and were randomly assigned to three experimental groups (n = 15). Group I was instrumented using Kedo-SG blue pediatric rotary files, Group II with Kedo-SH pediatric hand files, and Group III with reciprocating hand K-files. Standardized digital radiographs were taken before and after root canal instrumentation. Root canal preparation time was also recorded. Statistical analysis of the obtained data was done using SPSS software version 17.0. An intergroup comparison of the instrumentation time and the quality of obturation were done using ANOVA and Chi-square test with the level of significance set at 5%. P < 0.05 was considered statistically significant.
No significant differences were noted with regard to the quality of obturation between the three groups (P < 0.14). However, a statistically significant difference was noted in the instrumentation time between the three groups (P = 0.000). Kedo-SG blue rotary file had significantly lesser instrumentation time when compared to that of Kedo-SH hand files and reciprocating hand K-files.
On comparative evaluation Kedo-SG blue pediatric rotary file showed a marked reduction in instrumentation time, followed by Kedo-SH pediatric hand files and reciprocating hand K-files. Kedo-SG blue pediatric rotary file showed a marked reduction in instrumentation time, followed by Kedo-SH pediatric hand files and reciprocating hand K-files.
The main goal of pulpectomy is to eliminate the infection and prevent its further spread, at the same time retain the primary tooth until its exfoliation.
Although hand filing is the standard method of instrumentation of the primary root canals, it has certain limitations such as increased canal preparation time, uneven preparation of root canal space, and other iatrogenic errors.
Various Ni-Ti instruments which were proposed for use in permanent teeth were incorporated for use in primary teeth. ProTaper, M2, and K3 files were used for canal instrumentation with modified sequence to facilitate its use in primary teeth.
Ganesh Jeevanandan in 2017 introduced the exclusive pediatric rotary file which served the purpose, reducing the instrumentation time, resulting in an acceptable quality of obturation, favoring its use in pediatric endodontics.
Another rotary file that has been used for comparison in the present study is the reciprocating hand K-file. The unique feature of this file is that it minimizes the torsional and flexural stresses, increases the canal centering ability, and reduces the taper lock of the instrument within the canal, moving it more apt for application in primary tooth. There are no studies in the literature evaluating the application of reciprocating hand K-file in primary teeth. Hence, for use in primary teeth, these three instruments were selected for evaluation in the current study.
Hence, the aim of the present study was to comparatively evaluate the instrumentation time and the quality of obturation using Kedo-SG, Kedo-SH, and reciprocating hand K-files in primary molars.
A double-blinded randomized controlled trial was carried out in the Department of Paediatric and Preventive Dentistry, Saveetha Dental College, following the approval from the Institutional Review Board (SRB/MDS/PEDO/18-19/0009) from September 2018 to January 2019 in accordance with the ethical standards laid down in the 1964 declaration of Helsinki and its later amendments. Informed consent was obtained from the parents of the children who participated in the study. CONSORT guidelines (Altman et al. 2001) for planning and reporting clinical trials in pediatric endodontics were followed during the different stages of the study Flowchart describing the randomization of the participants and the parameters evaluated during the clinical trial.
Sample size estimation and study participant's selection
The sample size was calculated from a previous study with 95% power, alpha error at 5%, using G Power analysis, and arrived to a total sample of 45.
Healthy children between the age group of 4 and 8 years with complaint of night pain, having pulpally involved primary mandibular molars with minimum of two-thirds of remaining root length, and adequate coronal tooth to support the placement of rubber dam and to receive stainless steel crowns were included in the study. Children with systemic diseases, lacking cooperative ability, were excluded from the study. Furthermore, teeth with sinus opening, pathological root resorption, and inadequate coronal tooth structure to receive stainless steel crown were excluded from the study.
Before the study, an operator randomly allocated the sequence of the children to either a test or control group using computer-generated random numbers. Slips of paper with either Kedo-SG blue, Kedo-SH, and reciprocating files printed on them were placed in opaque envelopes and sealed. This was carried out by a person who was not associated with the study. These envelopes had been numbered sequentially on their outside with the patient identity number. Following the screening, as a child was accepted into the study, he or she was given their patient identity number. This ensured that the patient and the dentist carrying out the assessment were blind as to which group the child had been allocated.
Clinical procedure
Before the start of the clinical study, a full-mouth dental examination and appropriate standardized periapical radiographs were taken of mandibular posterior teeth with possible indication for pulpectomy.
To obtain accurate radiographs, the Rinn XCP instrument (Dentsply Rinn, Elgin) and radiographic parallelism and standard exposure technique were used to permit good visualization of the tooth structure as well as reproducibility.
A full-mouth dental examination with appropriate standardized intraoral periapical radiographs of the teeth indicated for pulpectomy was taken before the start of the clinical procedure. The working length was determined using the preoperative radiograph. To obtain accurate radiographs, the Rinn XCP instrument (Dentsply Rinn, Elgin) and radiographic parallelism and standard exposure technique were used to permit good visualization of the tooth structure as well as reproducibility. The primary tooth pulpectomy was carried out by the same operator in all cases after local anesthesia was administered using lignocaine (LOX *2% adrenaline, Neon Laboratories Limited, India). The tooth indicated for pulpectomy was isolated using rubber dam (GDC Marketing, India) for better visibility and to improve the efficiency of the operator. No. 6 round bur was used in a high-speed hand piece (NSK PANA AIR PA-SU B2) to remove the superficial caries, and complete deroofing of the pulp chamber was done using No. 330 pear shaper bur (Mani, Inc., Tochigi, Japan). No. 10 size K-file (Dentsply Maillefer, OK, USA) was used to determine the patency of the canals. The canal preparation was done as follows:
Group 1: Fifteen teeth were instrumented using Kedo-SG blue pediatric rotary files (Reeganz Dental Care Pvt. Ltd. India) as per the manufacturer's recommendation. D1 rotary files were used for canal preparation of the mesiobuccal and mesiolingual canals and E1 rotary files were used for distal canal preparation. The rotary files were used with an X-smart endodontic motor (Dentsply India Pvt. Ltd., Delhi, India) at 300 rpm and 2.2 N cm torque Group 2: Fifteen teeth were instrumented using Kedo-SH pediatric hand files (Reeganz Dental Care Pvt. Ltd. India) as per the manufacturer's recommendation. P1 pediatric hand K-file was used for initial patency of molar canals, P2 pediatric H file was used to extirpate the pulp, D1 to shape the narrower canals, and E1 to shape the wider canals Group 3: Fifteen teeth were instrumented from No. 15 size till No. 30 size K-files (Mani, Inc., Tochigi, Japan), which was coupled with NSK Endodontic Contra-Angle Reciprocating hand piece (TEP-ER10, Japan).
17% EDTA gel (RC help, Prime dental products, Pvt. Ltd. India) was used as a lubricating paste to coat the files before instrumentation into the canals. The irrigation solution was standardized to 1 ml of 1% sodium hypochlorite (SEPTODONT, HEALTHCARE, Pvt, Ltd) and 15 ml of saline in all the three groups. The canals were dried using sterile paper points. The root canals were obturated using Metapex (Meta Biomed Co. Ltd. Chungbuk, Korea) by gently pushing the material with cotton pellets. All the clinical procedures were done by a single operator to avoid operatory bias.
The instrumentation time was measured using a digital stopwatch and was recorded in seconds by a trained dental assistant. Instrumentation was done until there was no bleeding from the canals in vital teeth. A postobturation radiograph was taken to assess the quality of obturation. It was obtained for each tooth using the same radiographic settings as for preoperative. The assessment of obturation quality was based on Coll and Sadrian criteria as underfilled if all the canals were filled more than 2 mm short of the apex, optimally filled if one or more of the canals having Metapex ending at the radiographic apex or up to 2 mm short of the apex, and overfilled if any canal showing Metapex outside the root Immediate postoperative IOPA radiographs depicting different levels of quality of obturation. (a) Underfilling; (b) Optimal filling; (c) Overfilling.
Statistical analysis
The statistical analysis was done using SPSS software version 17.0 (SPSS Inc., Chicago, IL, USA). The mean values of different study groups were compared using ANOVA and Chi-square test. One-way ANOVA test was used to compare the instrumentation time between the three groups. Chi-square test was used to compare the quality of obturation between the three groups. The significance level was set at 5% for the present study.
A total of 45 children with a mean age of 6.14 years participated in the present study. Chi-square test between the groups with respect to age and sex shows an equal distribution of participants among the three groups
The current study compared the instrumentation time and quality of obturation of the pediatric manual, rotary, and reciprocating file system in the canal preparation of primary mandibular molars. There has been a phenomenal paradigm move in managing the infected primary teeth in children from extractions to pulpectomy. Pulpectomy has become an extensive pediatric endodontic procedure to preserve the arch length and guide the eruption of the underlying successional permanent tooth.
Primary root canal instrumentation with Ni-Ti rotary files has decreased the instrumentation time and has also resulted in a more uniform, funnel-shaped obturation. However, in previous studies, Ni-Ti files designed for permanent teeth have been used for pulpectomy in primary teeth.
In a survey conducted by Govindaraju et al. among the Indian dentists in 2017, it was observed that 66% of practitioners found that an exclusive pediatric rotary file would make pulpectomy procedure in primary teeth much easier and simpler in a clinical practice.
Kedo-S (Reeganz Dental Care Pvt. Ltd. India), an exclusively designed pediatric rotary file, was introduced to overcome the limitations caused on using permanent rotary files. Clinical trials comparing Kedo-S rotary file with hand files have shown remarkable reduction in instrumentation time and improvement in the quality of obturation.
The present study compared the quality of obturation and instrumentation time using Kedo-SG blue rotary files, Kedo-SH pediatric hand files, and reciprocating hand K-files. With respect to the quality of obturation in the present study, optimal filling was observed to be highest using Kedo-SG blue rotary files (73.3%), followed by Kedo-SH pediatric hand files (66.6%) and reciprocating hand K-files (20%). There was no statistically significant difference noticed among the three groups. The present study was similar to a study conducted by Priyadarshini et al., who reported 80% optimal filling with Kedo-SG rotary files.
A statistically significant reduction was noticed in the instrumentation time on using Kedo SG rotary files (83.00 ± 13.18 s) for canal preparation in primary mandibular molars when compared to Kedo SH pediatric hand files (135.13 ± 11.40 s) and reciprocating hand K files (190.60 ± 10.27 s). Earlier studies conducted comparing adult rotary files in primary tooth and pediatric rotary files with hand files showed reduced instrumentation time which is in accordance with the results of the present study.
Clinically, reduced instrumentation time has high influence on the behavior and cooperation of the child in the dental chair. It also lessens the fatigue caused by the operator, resulting in faster delivery of treatment.
Kedo-SG blue pediatric rotary file showed a marked reduction in instrumentation time, followed by Kedo-SH pediatric hand files. Hence, exclusive pediatric rotary and hand files should be incorporated into pediatric dental practice for an effective, faster, and safer dental treatment in children.
Financial support and sponsorship
Self-funded.
Conflicts of interest
The authors of this manuscript declare that they have no conflicts of interest, real or perceived, financial or non-financial in this article.