Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth

Study Overview
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Brief Summary
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Verify, through a randomized double-blinded clinical trial, the influence in the performance of pulpectomies in primary teeth, based on two working length methods, electronic and radiographic.

Detailed Description
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Samples will be composed of children between 6 and 9 years of age, with the need for endodontic treatment in primary teeth. They will be submitted to anamnesis, clinical and radiographic exams for identification of eligibility criteria for the study. These patients will be divided randomly into 2 groups: G1 - pulpectomy with working length method performed through radiography (n=100) and G2 - pulpectomy with working length method performed with the aid of an apex locator (n=100). Endodontic treatment will be done by a single trained operator. After definite restoration and final radiography, an evaluation of the obturation quality will be performed by another blinded operator, who will evaluate the appropriate obturation length. The clinical treatment success and the radiographies will also be analyzed during a period of 24 months through clinical and radiographic exams, also by a blinded operator.

Official Title
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Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth - Randomized Clinical Trial

Conditions
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Endodontically Treated Teeth

Intervention / Treatment
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* Other: Pulpectomies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary molars teeth with caries or defected restorations associated with signs or symptoms of irreversible pulpal inflammation - spontaneous pain or pulpal necrosis - presence of abscess, fistula, edema, periapical or inter-radicular radiolucency Exclusion Criteria: Primary molars teeth previously manipulated, with obliteration of the root canal, with bone reabsorption involving the crypt of the permanent tooth, internal or external pathological or physiological reabsorption involving more then half of the shortest root and unrestorable tooth

Ages Eligible for Study
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Minimum Age: 6 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
Interventional Model Description: Patients between 6 and 9 years old who search for endodontic treatment in primary teeth. The allocation of subjects to groups will be achieved by randomization. These patients will be randomly divided into 2 groups: G1 - pulpectomy with length measurement performed through radiography and G2 - pulpectomy with length measurement performed with the aid of an apex locator.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Operator 1<br>Perform the pulpectomies except the working length measurement | |
| No Intervention: Operator 2<br>Perform the electronic length measurement of the pulpectomies | |
| Active Comparator: Operator 3<br>Perform radiographic length measurement and final evaluation of the pulpectomies | Other: Pulpectomies<br>* Primary teeth pulpectomy is an important treatment option for necrotic teeth. The correct working length will determine a better chemical and mechanical disinfection of the root canals, without demanding the surrounding periapical tissues and dental germs. In addition, it decreases the chance of a sub or over-filling, which also may interfere with the achievement of the success.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Electronic Apex locator | The use of an electronic apex locator for the achievement of working length in primary teeth pulpectomies will demonstrate a similar or better result than the radiographic method for the obturation adequacy. Also it will show a closer or a better result in the evaluation of the clinical and radiographic success in a long-term treatment. | Evaluations will be done during 24 mouths after the pulpectomy performance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in length measurement methods for pulpectomies in primary teeth | Evaluate if there is a significant difference in the accuracy of electronic apex locators compared to the conventional radiography in working length measurements | Evaluations will be done during the pulpectomy performance | 
| Influence of working length measurement methods in the obturation level of pulpectomy in primary teeth | Evaluate the effect of two working length measurement methods in the obturation level of pulpectomy in primary teeth | Evaluations will be done after the pulpectomy performance | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpectomy, Primary teeth, Working length, Apex locator