Single Rotary File System Versus Conventional Manual K-file in Pulpectomy of Primary Molars.

Not Applicable

Not yet recruiting

• Conditions: Endodontically Treated Teeth
• Interventions: Procedure: Conventional Manual K files; Procedure: single file rotary

• Registration Number: NCT06151665
• Lead Sponsor: Ain Shams University

Brief Summary

The sample size will be divided between two groups, Group A pulpectomy will be done using single rotary file in primary molars and group B pulpectomy will be done using manual K file system. follow up of the patients and clinical and radiographical success rates of cases will be seen.

Detailed Description

Each patient will have access in the primary molar and pulpectomy procedure will be done according to inclusion and exclusion criteria , the patients will be divided according to two groups Group A using single File rotary and group B manual K file system. Time will be recorded in each procedure and each patient will receive stainless steel crown. Follow up for the patients will be done clinical and radiographical success will be seen, postoperative pain will be measured and all data will be collected and statistically analyzed.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-21
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30
• Study Start: 2023-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Absence of external or internal root resorption
2. presence of two thirds of the root
3. Primary molars with deep caries and irreversible pulpitis that require pulpectomy in a single visit. Molars can be vital with a history of spontaneous pain or non-vital as indicated by absence of bleeding from the pulp.

Exclusion Criteria

• Children with physical, intellectual disability or medical conditions that may complicate treatment.
• Teeth with poor prognosis due to the presence of a sinus, excessive mobility or advanced bone resorption.
• Teeth with radiolucent areas in furcation regions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Manual Files	Conventional Manual K files	Conventional Manual Stainless steel K files will be used in primary molars to preform pulpectomy then restored with zinc oxide eugenol and stainless steel crown.
Single Rotary file	single file rotary	single rotary file will be used in primary molars to preform pulpectomy then restored with zinc oxide eugenol and stainless steel crown.

Primary Outcome Measures

Name	Time	Method
Clinical and Radiographical Success	1 year	Clinical evaluation to swelling, fistula and pain on percussion by clinical examination followed by a radiographic evaluation to absence of periapical and inter-radicular radiolucency, external or internal root resorption according to radiographic images

Secondary Outcome Measures

Name	Time	Method
postoperative pain	3 days	Postoperative pain will be recorded at six, 12, 24, 48, and72 hours following the pulpectomy. To ensure standardization, the same parent will be asked to record the pain intensity at all intervals as told by the child. Wong Bakers FACES Pain Rating Scale (WB-FPRS) will be employed to assess post-operative pain. The scale is a pictorial representation of the discomfort level experienced by children which comprise six faces, each depicting an expression of pain. Also visual Analogue Scale (VAS) for pain assessment will be used.

Trial Locations

Locations (1)

Faculty of dentistry Ain shams University; 🇪🇬 Cairo, Egypt