Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation
NCT ID: NCT05619796
Last Updated: 2023-12-07
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-09-04
2023-07-30
Brief Summary
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Little studies have been done to clinically evaluate the Kedo-S Square \& Fanta AF™ Baby rotary systems in relation to the quality of obturation, instrumentation time and postoperative pain in root canal preparation of primary molars using CBCT.
Detailed Description
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The use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. Numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. As a result, there was a great need for the development of a unique pediatric rotary file system.
The Kedo-S Square rotary system is a single file system specifically designed for paediatric use. It consists of two files, one for anterior primary teeth (A1) and one for posterior primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology.
A good root canal treatment in primary teeth is dependent on the quality of biomechanical preparation, the type of obturating material used with as few voids as possible, and the achievement of a good hermetic seal. Also, treatment time is an important aspect as reduced chairside time increases children's cooperation for dental treatment, reduces anxiety, and making the treatment protocol optimal. Another factor affecting the success of primary teeth pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into peri-radicular tissues accordingly, causing inflammation and releasing inflammatory mediators.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain.
Study Groups
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group 1: Kedo-S Square rotary files
Primary root canals(n=20) were instrumented using rotary P1 Kedo-S Square files (Reeganz Dental Care Pvt. Ltd. India) at 300 rpm and 2.2N cm torque. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation.
pulpectomy procedure
single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.
Post-operative Cone Beam Computed Tomography
post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).
The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .
Post-operative pain assessment
The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.
group II: Fanta AFTM-Baby rotary system
Primary root canals(n=20) were instrumented using Fanta AFTM-Baby rotary system (Shanghai Fanta Dental Materials, SUNGO Certification Company Limited, London, England) at 350 rpm and 2 N cm torque. Four files were used sequentially in the following order; open file #17/0.08, #20/0.04 yellow, #25/0.04 red and #30/0.04 blue. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation.
pulpectomy procedure
single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.
Post-operative Cone Beam Computed Tomography
post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).
The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .
Post-operative pain assessment
The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.
group III: manual K-files
Primary root canals(n=20) were instrumented using No.15 till 35 size manual K-files (Mani, Inc, Japan) using the quarter-turn-pull technique.
pulpectomy procedure
single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.
Post-operative Cone Beam Computed Tomography
post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).
The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .
Post-operative pain assessment
The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.
Interventions
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pulpectomy procedure
single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.
Post-operative Cone Beam Computed Tomography
post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).
The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .
Post-operative pain assessment
The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* non-vital posterior teeth with sufficient coronal structure
* intact 2/3rd root structure
* no mobility or external pathological root resorption
Exclusion Criteria
* children with systemic illness
* non-restorable primary molars
* primary molars with sever mobility, or pathological root resorption
4 Years
7 Years
ALL
Yes
Sponsors
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Tanta University
OTHER
Responsible Party
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Shaimaa Shaban Mohamed El-desouky
Lecturer of Pediatric dentistry
Locations
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Tanta University
Tanta, Gharbia Governorate, Egypt
Countries
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References
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Barr ES, Kleier DJ, Barr NV. Use of nickel-titanium rotary files for root canal preparation in primary teeth. Pediatr Dent. 2000 Jan-Feb;22(1):77-8.
Jeevanandan G, Govindaraju L. Clinical comparison of Kedo-S paediatric rotary files vs manual instrumentation for root canal preparation in primary molars: a double blinded randomised clinical trial. Eur Arch Paediatr Dent. 2018 Aug;19(4):273-278. doi: 10.1007/s40368-018-0356-6. Epub 2018 Jul 12.
Mohamed RH, Abdelrahman AM, Sharaf AA. Evaluation of rotary file system (Kedo-S-Square) in root canal preparation of primary anterior teeth using cone beam computed tomography (CBCT)-in vitro study. BMC Oral Health. 2022 Jan 18;22(1):13. doi: 10.1186/s12903-021-02021-0.
Abd El Fatah YAM, Khattab NMA, Gomaa YF, Elheeny AAH. Cone-beam computed tomography analysis of primary root canals transportation and dentin loss after instrumentation with two-pediatric rotary files. BMC Oral Health. 2022 May 31;22(1):214. doi: 10.1186/s12903-022-02245-8.
Elheeny AAH, Abdelmotelb MA. Postoperative pain after primary molar pulpectomy using rotary or reciprocating single files: A superior, parallel, randomized clinical trial. Int J Paediatr Dent. 2022 Nov;32(6):819-827. doi: 10.1111/ipd.12959. Epub 2022 May 5.
Other Identifiers
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#R-PED-9-22-2
Identifier Type: -
Identifier Source: org_study_id