- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490605
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
46
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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides
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.
|
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
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
Collaborators
Investigators
- Principal Investigator: Maria Luiza MA Frigerio, PhD, Universidade de São Paulo - Brazil - 05508-900
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
July 1, 2015
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
June 5, 2015
First Submitted That Met QC Criteria
July 1, 2015
First Posted (Estimate)
July 7, 2015
Study Record Updates
Last Update Posted (Estimate)
July 7, 2015
Last Update Submitted That Met QC Criteria
July 1, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Anti-Infective Agents
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
Other Study ID 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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