Single-file Pulpectomy in Primary Molars

Study Overview
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Brief Summary
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The current study evaluates the rotational One Shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars. This randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. Group I: 47 primary molars were instrumented with One Shape rotational single-file system. Group II: 47 primary molars were instrumented with stainless steel K-files. All teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.

Official Title
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Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.

Conditions
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Pulpal Necrosis

Intervention / Treatment
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* Other: One Shape Single-file rotary system
* Other: manual stainless steel K-file


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children categorized as class I or II according to American Society of Anesthesiologists (ASA). Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar. History of dull toothache over an extended period of time History of spontaneous pain or pain at night Swelling adjacent to tooth with or without a sinus tract Abnormal tooth mobility Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed Interruption of lamina dura or thickening of periodontal ligament space Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor Negative findings of internal root resorption External root resorption confined to the apical third and with at least two-thirds of the root length was intact Exclusion Criteria: Uncoperative children or parents/legal guardians Sever intellectual, behaviour or emotional problems Non-restorable tooth crowns Root canal obliteration Presence of underlying dentigerous or follicular cysts

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One Shape Single-file rotary system<br> | Other: One Shape Single-file rotary system<br>* rotational single file system used for mechanical debridement of root canals<br>|
| Active Comparator: Manual stainless steel K-file<br> | Other: manual stainless steel K-file<br>* sequential manual filing with stainless steel K-files<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain presence or absence | score 0 was applied for absence of pain and score 1 was applied for presence of pain | one year | 
| swelling presence or absence | score 0 was applied for absence of swelling and score 1 was applied for presence of swelling | one year | 
| radiographic success or failure | it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpectomy, Pediatric Dentistry