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Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth

NCT06152354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-30

No results posted yet for this study

Summary

The teeth were randomly allocated in two equal groups :

Control group (A):- included 20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35.

Experimental Group (B):- included 20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturer's instructions

Methods of Evaluation

Stage I :- During and after canal preparation:- The following parameters were evaluated for all cases in both groups:- A- The instrumentation and canal filling time were recorded for both groups using stopwatch. B- Radiographic assessment for filling were done immediately postoperative to record :-

1. Distance between the apex to filling level of the mesial and distal roots .
2. Obturation form

Stage II : Follow up :

The follow up were carried out by clinical and radiographic evaluation for all cases in both groups:-

The clinical evaluation were carried out at (0 base line = after 7 days ) then after 1 , 3 , 6 and 12 months .

Radiographic evaluation were performed immediately postoperative as (0 baseline ) after cementation of stainless steel crowns for assessment of filling quality. Radiographs will be used for comparison for consequent radiographs . Follow ups were performed after 6 and 12 months.

Conditions

  • Pulpitis

Interventions

DEVICE

rotary system

crown down technique using Kedo-SG file rotary system using endodontic motor

DEVICE

Manual files

instrumentation were done by step back technique using K- file (Mani ) from size 15 to size 35 in quarter pull turn motion apically

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-02
Primary Completion
2023-10-02
Completion
2023-10-18

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 NCT06152354 on ClinicalTrials.gov