NCT06152354

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

Completed NA Last updated 30 November 2023

What this trial tests

NA trial testing rotary system in Pulpitis in 40 participants. Completed in 18 October 2023.

Timeline

2 October 2022

Primary endpoint
2 October 2023

18 October 2023

Quick facts

Lead sponsor	Suez Canal University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	2 October 2022
Primary completion	2 October 2023
Estimated completion	18 October 2023
Sites	1 location across Egypt

Drugs / interventions tested

• rotary system
• Manual files

Conditions studied

• Pulpitis — all drugs for Pulpitis →

Sponsor

Suez Canal University

Who can join

Adults 4 to 6, any sex, with Pulpitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.