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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparative Study Between Single Rotary File System and Conventional Manual K-File in Pulpectomy of Primary Molars.

Conditions
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Endodontically Treated Teeth

Intervention / Treatment
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* Procedure: single file rotary
* Procedure: Conventional Manual K files


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of external or internal root resorption presence of two thirds of the root 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Primary molars with irreversible pulpitis
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Rotary file<br>single rotary file will be used in primary molars to preform pulpectomy then restored with zinc oxide eugenol and stainless steel crown. | Procedure: single file rotary<br>* Kedo-S plus file is the fifth generation of pediatric files will be used in pulpectomy of primary molars<br>|
| Active Comparator: Conventional Manual Files<br>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. | Procedure: Conventional Manual K files<br>* Stainless-steel K files is the golden standard files used in pulpectomy of primary molars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and Radiographical Success | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | 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. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary-molars, pulpectomy, Rotary