Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation

April 5, 2017 updated by: Maximiliano Sergio Cenci, Federal University of Pelotas

Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.

The edentulism and use of inadequate dentures, unstable and with teeth worn because long period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa relation. The reline of the denture base and the use of interocclusal appliance prior to definitive rehabilitation could have influence on these functional aspects. However, there are not Randomized Controlled clinical Trials (RCTs) testing the combined use of these two treatments in reestablishing these functional aspects. The, aim of this study is to evaluate whether the denture base reline and the use of interocclusal appliance prior to final rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete denture wearers. For this controlled, crossover, randomized and blinded clinical trial, 30 volunteers, totally edentulous, complete denture wearer over a period of five year, will be selected. The volunteers will be randomly allocated into three subgroups (n= 10) and will receive the following treatments: Control (C)Volunteers will receive new complete denture without any previous intervention in their old complete denture; Relining Denture (RD)Volunteers will be submitted to the relining of the base of the their old complete denture and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed; Interocclusal Appliance (IA) Volunteers will be submitted to the treatment with interocclusal appliance and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed. Volunteers will be evaluated regarding the extent of mandibular movement by intraoral record of Gothic Gysi arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical dimension by Willis compass and photographic record. These evaluations will be performed at three periods, T0 baseline; T1 after application of randomized treatment, reline denture and interocclusal appliance); T3 after final rehabilitation. The control group will be evaluated only at periods T0 and T3.

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.

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 (Actual)

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.
30

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
    • Rio Grande do Sul
      • Pelotas, Rio Grande do Sul, Brazil, 96015-560
        • School of Dentistry, Federal University of Pelotas

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adults suffering from upper and lower denture indicated for replacement due to use exceeding five years;
  2. Have availability to attend FO / UFPel days predetermined;
  3. Agree with the term informed consent, approved by the research ethics committee of FO / UFPel.

Exclusion Criteria:

  1. Patients younger than 40 years;
  2. Patients who are not users of denture upper and lower;
  3. Patients denture wearers during periods of less than five years.

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.
Experimental: Interocclusal appliance
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Procedure: interocclusal appliance
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Procedure: Complete denture rehabilitation
All patients will be rehabilitated with new complete dentures in the study
Experimental: Relining complete denture base
Patients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures.
Procedure: Complete denture rehabilitation
All patients will be rehabilitated with new complete dentures in the study
Procedure: Relining of the complete dentures
Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.
Active Comparator: Only Rehabilitation
Patients will be treated with a complete denture without any kind of previous intervention
Procedure: Complete denture rehabilitation
All patients will be rehabilitated with new complete dentures in the study

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
Change from baseline of the occlusal vertical dimension after treatment at 6 months
Time Frame: 30 days after randomization; and 30 days after final prosthetic rehabilitation
30 days after randomization; and 30 days after final prosthetic rehabilitation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the extension of the mandibular movements up to 6 months.
Time Frame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
The extent of mandibular movement will be assessed by intramural record of Gothic Gysi arch.
30 days after randomization; and 30 days after the final prosthetic rehabilitation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the condyle-fossa relation up to six months
Time Frame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
The condyle-fossa relation will be measured by cone-bean computed tomographic scan.
30 days after randomization; and 30 days after the final prosthetic rehabilitation

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.
Federal University of Pelotas

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

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.
August 1, 2013

Primary Completion (Actual)

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.
December 1, 2015

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 1, 2017

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).
September 13, 2013

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.
December 13, 2013

First Posted (Estimate)

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.
December 19, 2013

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 6, 2017

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 5, 2017

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, 2017

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.
  • PPGO0014

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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