Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments

Study Overview
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Brief Summary
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The aim of this study is through a randomized clinical trial, double blind, splitmouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Detailed Description
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The need for endodontic treatment is still very common in the clinical routine, whether due to dento-alveolar trauma or caries. In some cases, the temporary filling procedure is required until the endodontic treatment is completed. The temporary filling material should be biocompatible and bacteriostatic. The aim of this study is through a randomized clinical trial, double blind, split-mouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Twenty participants with at least two teeth with the need of endodontic treatment will be selected. The teeth will be randomly divided into 2 different groups according to the temporary filling material composition (Based on calcium hydroxide; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

Official Title
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Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments - Randomized Clinical Study

Conditions
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MTA, Calcium Hydroxide, Endodontic Treatment

Intervention / Treatment
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* Procedure: Carie removal
* Procedure: Absolute isolation
* Drug: Manipulation of the temporary filling material based on Calcium Hydroxide
* Drug: Manipulation of the temporary filling material based on Mineral trioxide aggregate
* Procedure: Material insertion on the root canal
* Procedure: Material re-insertion on the root canal accordging to the infection needs.
* Procedure: Definiteve canal root obturation
* Procedure: Definitve restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Both genres Presence of at least two teeth with indication of endodontic treatment Good oral hygiene Exclusion Criteria: Dentures or orthodontics Presence of periodontal disease Presence of parafunctional habits Presence of systemic disease Presence of severe psychological disturbe; Constant use of analgesic and, or anti-inflammatory Allergic response to dental products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: Calcium Hydroxide temporary filling material<br>Temporary filling with Ca(OH)2 | Procedure: Carie removal<br>* Carie removal with a low speed handpiece<br>Procedure: Absolute isolation<br>* Absolute isolation with rubber dam<br>Drug: Manipulation of the temporary filling material based on Calcium Hydroxide<br>* Manipulation of the temporary material based on Calcium Hydroxide according to the manufacturer's recommendations.<br>Procedure: Material insertion on the root canal<br>* Material insertion on the root canal according to the manufacturer's recommendations<br>Procedure: Material re-insertion on the root canal accordging to the infection needs.<br>* Material re-insertion on the root canal according to the manufacturer's recommendations<br>Procedure: Definiteve canal root obturation<br>* Definiteve canal root obturation with gutta-percha and definitive cement.<br>Procedure: Definitve restoration<br>* Definitve restoration confecction.<br>|
| Active Comparator: MTA temporary filling material<br>Temporary filling with MTA | Procedure: Carie removal<br>* Carie removal with a low speed handpiece<br>Procedure: Absolute isolation<br>* Absolute isolation with rubber dam<br>Drug: Manipulation of the temporary filling material based on Mineral trioxide aggregate<br>* Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations.<br>Procedure: Material insertion on the root canal<br>* Material insertion on the root canal according to the manufacturer's recommendations<br>Procedure: Material re-insertion on the root canal accordging to the infection needs.<br>* Material re-insertion on the root canal according to the manufacturer's recommendations<br>Procedure: Definiteve canal root obturation<br>* Definiteve canal root obturation with gutta-percha and definitive cement.<br>Procedure: Definitve restoration<br>* Definitve restoration confecction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up. |  | 1 year | 
| Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up. |  | 1 year | 
| Presence of exudate between the treatment's sessions of endodontically treated teeth that required filling with temporary material with a 1 year follow up. |  | 1 year |