Effect of the Use of an Occlusal Plate on the Postural Alignment (Simone)

July 1, 2015 updated by: Simone Saldanha Ignacio de Oliveira, University of Sao Paulo

Effect of the Use of an Occlusal Plate on the Postural Alignment and Balance of Individuals With Signs and Symptoms of Temporomandibular Joint Disorder

The possible relationship between posture and instability of the masticatory muscles related to occlusion thus becomes the reason, the objective of this study. In this way, it will be possible to evaluate both postural alignment and postural balance in patients with signs and symptoms of temporomandibular joint disorder before and after the use of an occlusal plate. Our research will take place at the School of Odontology of the University of São Paulo in the clinics of the Occlusion and TMJ Services (SOA) and of the Envelhecer Sorrindo program, and the data will be collected in the Biophysics Laboratory of the School of Physical Education and Sports of the University of São Paulo. The population studies will be made up of 120 patients, 60 being part of the sample and the other 60 in the control group. All the patients in this study are over 20 years of age and are of both genders; the research criteria will be diagnosed by way of filling out the questionnaire of the RDC-TMD and complemented by way of diagnostic imaging via MRI of the temporomandibular joint. The study will be a clinical, randomized, controlled, prospective study and intervention. After the subjects' alignment is evaluated by way of photographs and their postural balance by way of a force platform, the group will the randomized; the sample group will receive an occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides). The occlusal plate will be made from "Vacuum Form" acetate with a thickness of 1.5 mm; the simultaneous, bilateral, occlusal contacts and the canine and anterior guides will be obtained by way of autopolymerizable, acrylic resin with the mandible in a centric relationship. The occlusal plate will be controlled weekly. The control group will only receive orientation to do physiotherapeutic exercises seeking to correctly position the mandible in the resting position (maxillar teeth should be approximately 2 mm away from the mandibular teeth) while the tip of the tongue is positioned and accommodated on the roof of the mouth over the incisive papilla on the hard palate (without touching the teeth). The exercise will consist of repeatedly opening the mouth with the tongue cleaving to the roof of the mouth, 3 times per day, each period consisting of 3 sets with 15 repetitions. After 3 months, the two groups will be re-evaluated in terms of postural alignment and balance.

Study Overview

Status

Status

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

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

The data will undergo the pertinent statistical treatment. The supposition is that those who undergo re-education of their neuromuscular system will see improvement in their coordination and understanding in relationship to TMJ, re-establishing the function by way of the occlusal stability.

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.
46

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

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Study Contact

Study Contact

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Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-900
        • Universidade de São Paulo

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are more than 20 years old,
  • Both genders,
  • Patients who present signs and symptoms of TMD identified by way of filling out the questionnaire of the RDC-TMD (Diagnostic Research Criteria) complemented by way of diagnostic imaging via an MRI of the temporomandibular joint.
  • Patients who have their natural teeth, allowing for the use of partial, removable, Class-III Kennedy prostheses with small and medium spaces (up to 3 elements), having as a criteria posterior control (patients with partial, removable prostheses without presenting any type of compression marks or lesions under the structure, points of trauma indicated by redness of the mucosa, and verification of simultaneous, bilateral contacts) (Stegun; Costa, 2000).
  • Patients who undergo the MRI of the temporomandibular joint at the time of the evaluation.

Exclusion Criteria:

  • Patients entirely without unimaxillar and bimaxillar teeth,
  • Patients with a dislocated disc without reduction,
  • Patients with a history of cervical macrotraumas,
  • Patients who continually use analgesics and anti-inflammatories, and/or medications that might effect their balance,
  • Patients with compromised vision without corrections,
  • Patients with neurological alterations,
  • Patients with a history of falls,
  • Patients with diabetes accompanied by sensitive neuropathies,
  • Patients who complain of labyrinthitis.

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: None (Open Label)

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: occlusal plate group
The sample group will receive an occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides). The occlusal plate will be made from "Vacuum Form" acetate with a thickness of 1.5 mm; the simultaneous, bilateral, occlusal contacts and the canine and anterior guides will be obtained by way of autopolymerizable, acrylic resin with the mandible in a centric relationship.
Procedure: occlusal plate group
occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides
Procedure: therapeutic exercises
The exercise will consist of the movement of repeatedly opening the mouth with the tongue cleaving to the "roof of the mouth" 3 times per day with each period consists of of 3 sets with 15 repetitions
Active Comparator: therapeutic exercises
The control group will only receive orientation to do physiotherapeutic exercises seeking to correctly position the mandible in the resting position (maxillar teeth should be approximately 2 mm away from the mandibular teeth) while the tip of the tongue is positioned and accommodated on the roof of the mouth over the incisive papilla on the hard palate (without touching the teeth). The exercise will consist of repeatedly opening the mouth with the tongue cleaving to the roof of the mouth, 3 times per day, each period consisting of 3 sets with 15 repetitions.
Procedure: therapeutic exercises
The exercise will consist of the movement of repeatedly opening the mouth with the tongue cleaving to the "roof of the mouth" 3 times per day with each period consists of of 3 sets with 15 repetitions

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
Measure Description
Time Frame
To investigate the effects of the use of occlusal splint over postural alignment
Time Frame: twelve weeks
alignment will be evaluate by means 32 anatomic points to evaluate posture via the SAPO protocol, which is based on the evaluation of the subject in four photographic views (anterior front, posterior front, right side, and left side)
twelve weeks

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.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maria Luiza Moreira Arantes Frigerio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Luiza MA Frigerio, PhD, Universidade de São Paulo - Brazil - 05508-900

Study record dates

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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.
July 1, 2015

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.
September 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, 2015

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).
June 5, 2015

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.
July 1, 2015

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.
July 7, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
July 7, 2015

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.
July 1, 2015

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.
July 1, 2015

More Information

Terms related to this study

Keywords

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.
  • Simone

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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