Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation

NCT05619796 | Completed

• 1 other identifier: #R-PED-9-22-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Manual files used for the pulpectomy of primary teeth have some disadvantages such as time wastage and the occurrence of iatrogenic errors compared to rotary systems. 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.

Conditions

Manual; Rotation; Obturation; Post Operative Pain

Keywords

Cone-beam computed tomography; kedo-S square; Fanta AF™ Baby

Outcome Measures

Primary Outcomes (1)

• Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth

  by evaluation of the obturation quality using immediate post-operative CBCT which is assessed by two trained pediatric dentists, blinded to instrumentation technique . The quality of obturation was assessed by evaluating the length of the Metapex filling according to Coll and Sadrian criteria : * Under filling (Score 1): Canal filled with metapex more than 2 mm short of the apex. * Optimal filling (Score 2): Canal filling ending at the radiographic apex or up to 2 mm short of apex. * Overfilling (Score 3): Any canal showing filling outside the root apex.

  2 days

Secondary Outcomes (1)

• postoperative pain after primary teeth pulpectomy using Manual and Pediatric Rotary File Systems

  2 days

Study Arms (3)

group 1: Kedo-S Square rotary files

EXPERIMENTAL

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.

Procedure: pulpectomy procedure; Radiation: Post-operative Cone Beam Computed Tomography; Other: Post-operative pain assessment

group II: Fanta AFTM-Baby rotary system

EXPERIMENTAL

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.

Procedure: pulpectomy procedure; Radiation: Post-operative Cone Beam Computed Tomography; Other: Post-operative pain assessment

group III: manual K-files

ACTIVE COMPARATOR

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.

Procedure: pulpectomy procedure; Radiation: Post-operative Cone Beam Computed Tomography; Other: Post-operative pain assessment

Interventions

pulpectomy procedure 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.

group 1: Kedo-S Square rotary files; group II: Fanta AFTM-Baby rotary system; group III: manual K-files

Post-operative Cone Beam Computed Tomography RADIATION

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 .

Also known as: Obturation Quality Assessment

group 1: Kedo-S Square rotary files; group II: Fanta AFTM-Baby rotary system; group III: manual K-files

Post-operative pain assessment OTHER

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 1: Kedo-S Square rotary files; group II: Fanta AFTM-Baby rotary system; group III: manual K-files

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy cooperative children
• non-vital posterior teeth with sufficient coronal structure
• intact 2/3rd root structure
• no mobility or external pathological root resorption

You may not qualify if:

• Uncooperative children
• children with systemic illness
• non-restorable primary molars
• primary molars with sever mobility, or pathological root resorption

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 6624033, Egypt

Location

Related Publications (5)

• 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.

  PMID: 10730297 BACKGROUND

• 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.

  PMID: 30003514 BACKGROUND

• 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.

  PMID: 35042489 BACKGROUND

• 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.

  PMID: 35641977 BACKGROUND

• 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.

  PMID: 35152509 BACKGROUND

MeSH Terms

Conditions

Bites and Stings; Pain, Postoperative

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric dentistry

Model Details: A randomized, controlled prospective clinical study

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: September 4, 2022
• Primary Completion: March 4, 2023
• Study Completion: July 30, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

EG (1)