Influence of the Composition of Temporary Restorative Material in Vital Teeth

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, splithmouth, evaluate the success rate (retation rate and dental sensibility) of temporary direct restorations in vital teeth. The composition of the temporary direct restoration (based on Zinc-Oxide with Eugenol; and mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

Detailed Description
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The confection of temporary direct restoration is still verry commom in dental clinic routine, either by the time required or by biological requirements.The temporary restorations must have sufficient retention and solubility between the consultation intervals to avoid displacement and infiltration; besides being biocompatible to avoid sensitivity. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retention rate and dental sensibility) of temporary direct restoration on vital teeth. The composition of the temporary material (based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate) will be evaluated. Twenty-five participants with at least two vital teeth with the need to confection of direct restoration (each participant) will be selected. The teeth will be randomly divided into 2 different groups according to the temporary material composition (Based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

Official Title
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Influence of the Composition of Temporary Restorative Material on the Retention Rate and Sensitivity for Provisional Direct Restorations in Vital Teeth - Clinical Study Randomized

Conditions
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MTA, Dental Restoration, Temporary

Intervention / Treatment
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* Procedure: Carie removal
* Procedure: Relative isolation
* Procedure: Manipulation of the temporary material based on Zinc Oxide and Eugenol
* Procedure: Manipulation of the temporary material based on Mineral trioxide aggregate
* Procedure: Material insertion on the cavity
* Procedure: Finishing the temporary direct 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 direct restoration; good oral hygiene. Exclusion Criteria: Dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or 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: Zinc oxide and eugenol<br>Temporary direct restoration with zinc oxide and eugenol. | Procedure: Carie removal<br>* Carie removal with a low speed handpiece<br>Procedure: Relative isolation<br>* Relative isolation with cotton and gauze.<br>Procedure: Manipulation of the temporary material based on Zinc Oxide and Eugenol<br>* Manipulation of the temporary material based on Zinc Oxide and Eugenol according to the manufacturer's recommendations<br>Procedure: Material insertion on the cavity<br>* Material insertion on the cavity according to the manufacturer's recommendations<br>Procedure: Finishing the temporary direct restoration<br>* Excess cement removal; Occlusal Adjustment; Finishing and polishing.<br>|
| Active Comparator: Mineral trioxide aggregate<br>Temporary direct restoration with Mineral trioxide aggregate. | Procedure: Carie removal<br>* Carie removal with a low speed handpiece<br>Procedure: Relative isolation<br>* Relative isolation with cotton and gauze.<br>Procedure: Manipulation of the temporary 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 cavity<br>* Material insertion on the cavity according to the manufacturer's recommendations<br>Procedure: Finishing the temporary direct restoration<br>* Excess cement removal; Occlusal Adjustment; Finishing and polishing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate (retention rate and absence of sensibility) of temporary direct restoration with diferents temporary materials with a 15 days of follow up |  | 15 days |