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

NCT05619796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-07

No results posted yet for this study

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

Interventions

PROCEDURE

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.

RADIATION

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 .

OTHER

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.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-04
Primary Completion
2023-03-04
Completion
2023-07-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05619796 on ClinicalTrials.gov