Influence of the Composition of Temporary Restorative Material in Vital Teeth

March 6, 2018 updated by: PAULO VINICIUS SOARES, Federal University of Uberlandia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Uberlandia, Minas Gerais, Brazil, 381440617
        • Federal University of Uberlandia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zinc oxide and eugenol
Temporary direct restoration with zinc oxide and eugenol.
Procedure: Carie removal
Carie removal with a low speed handpiece
Procedure: Relative isolation
Relative isolation with cotton and gauze.
Procedure: Manipulation of the temporary material based on Zinc Oxide and Eugenol
Manipulation of the temporary material based on Zinc Oxide and Eugenol according to the manufacturer's recommendations
Procedure: Material insertion on the cavity
Material insertion on the cavity according to the manufacturer's recommendations
Procedure: Finishing the temporary direct restoration
Excess cement removal; Occlusal Adjustment; Finishing and polishing.
Active Comparator: Mineral trioxide aggregate
Temporary direct restoration with Mineral trioxide aggregate.
Procedure: Carie removal
Carie removal with a low speed handpiece
Procedure: Relative isolation
Relative isolation with cotton and gauze.
Procedure: Material insertion on the cavity
Material insertion on the cavity according to the manufacturer's recommendations
Procedure: Finishing the temporary direct restoration
Excess cement removal; Occlusal Adjustment; Finishing and polishing.
Procedure: Manipulation of the temporary material based on Mineral trioxide aggregate
Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2018

Primary Completion (Anticipated)

April 30, 2018

Study Completion (Anticipated)

October 30, 2018

Study Registration Dates

First Submitted

February 11, 2018

First Submitted That Met QC Criteria

February 11, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.358.776

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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