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

April 6, 2018 updated by: PAULO VINICIUS SOARES

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Uberlândia

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

14 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 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

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: Calcium Hydroxide temporary filling material
Temporary filling with Ca(OH)2
Procedure: Absolute isolation
Absolute isolation with rubber dam
Procedure: Carie removal
Carie removal with a low speed handpiece
Drug: Manipulation of the temporary filling material based on Calcium Hydroxide
Manipulation of the temporary material based on Calcium Hydroxide according to the manufacturer's recommendations.
Procedure: Material insertion on the root canal
Material insertion on the root canal according to the manufacturer's recommendations
Procedure: Material re-insertion on the root canal accordging to the infection needs.
Material re-insertion on the root canal according to the manufacturer's recommendations
Procedure: Definiteve canal root obturation
Definiteve canal root obturation with gutta-percha and definitive cement.
Procedure: Definitve restoration
Definitve restoration confecction.
Active Comparator: MTA temporary filling material
Temporary filling with MTA
Procedure: Absolute isolation
Absolute isolation with rubber dam
Procedure: Carie removal
Carie removal with a low speed handpiece
Procedure: Material insertion on the root canal
Material insertion on the root canal according to the manufacturer's recommendations
Procedure: Material re-insertion on the root canal accordging to the infection needs.
Material re-insertion on the root canal according to the manufacturer's recommendations
Procedure: Definiteve canal root obturation
Definiteve canal root obturation with gutta-percha and definitive cement.
Procedure: Definitve restoration
Definitve restoration confecction.
Drug: Manipulation of the temporary filling 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
Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
Time Frame: 1 year
1 year
Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
Time Frame: 1 year
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.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

PAULO VINICIUS SOARES

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)

May 1, 2018

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.527.632

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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