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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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