Single Rotary File Pulpectomy in Primary Molars

Study Overview
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Brief Summary
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The aim of this study is to compare the clinical effectiveness of a single rotary file system versus a multiple rotary files system in pulpectomy of primary molars

Detailed Description
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In pediatric dentistry, premature loss of necrotic primary molars has been a matter of great concern over the years. In modern pedodontic practice, Pulpectomy is regarded as the choice modality of treatment for pulpally involved necrotic teeth. Hand files are used for mechanical preparation of primary tooth during pulpectomy but it has been found to be time consuming and may negatively influence the child's behavior . Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure. These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications. Up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of single rotary file systems versus multiple rotary files systems when used in pulpectomy of primary molars. Thus, the present study aims to investigate the clinical effectiveness of those two techniques

Official Title
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Clinical Effectiveness of Single Rotary File Versus Multiple Rotary Files in Pulpectomy of Primary Molars : A Randomized Clinical Trial

Conditions
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Pulpitis - Irreversible

Intervention / Treatment
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* Device: Fanta AF blue rotary files 20 taper 4
* Device: Fanta AF baby rotary files 20 , 25 , 30 taper 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children Criteria: Medically free . Cooperative patient. Molar criteria : • Mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis Radiographic criteria: No evidence of internal/external pathologic root resorption. With or without periapical or furcal lesion . Exclusion Criteria: • Uncooperative children. Children with systemic disease. Lack of informed consent by the child patient's parent. Refusal of participation.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I ( pulpectomy using single rotary file )<br>After opening the access cavity, a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline | Device: Fanta AF blue rotary files 20 taper 4<br>* single rotary file Fanta AF blue rotary files 20 taper 4<br>|
| Active Comparator: Group II ( pulpectomy using multiple rotary files system )<br>After opening the access cavity, multiple rotary files system (Fanta AF baby rotary files 20 taper 4, 25 taper 4, 30 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at rotational speed 300 rpm with torque set at the lowest level, irrigation with saline | Device: Fanta AF baby rotary files 20 , 25 , 30 taper 4<br>* multiple rotary files system Fanta AF baby rotary files 20 , 25 , 30 taper 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| instrumentation time | instrumentation time of pulpectomy using single rotary file by stopwatch | during the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child's cooperation level | child's cooperation level using Frenkel's behaviour rating scale using Grades ( 1- Definitely negative 2- negative 3- positive 4- definitely positive ) | baseline and during the operation | 
| obturation quality | obturation quality measuring using periapical radiographs using Coll and Sadrian criteria ( scores) the quality of the root canal filling was defined as : underfilling : all the canals were filled more than 2 mm short of the apex optimal filling : one or more of the canals having the obturant ending at the radiographic apex or up to 2 mm short of the apex overfilling : any canal showing obturant outside the root | immediately after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single rotary file pulpectomy , primary molars