Effect of the Use of an Occlusal Plate on the Postural Alignment

NCT ID: NCT02490605

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

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.

Conditions

Temporomandibular Joint Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

occlusal plate group

Intervention Type: PROCEDURE

occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides

therapeutic exercises

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

therapeutic exercises

Intervention Type: PROCEDURE

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

Interventions

occlusal plate group

occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maria Luiza Moreira Arantes Frigerio

UNKNOWN

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Simone Saldanha Ignacio de Oliveira

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Luiza MA Frigerio, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade de São Paulo - Brazil - 05508-900

Locations

Universidade de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Simone Oliveira, PhD

Role: CONTACT

simone_s_oliveira@hotmail.com

+55-21-991245952

Facility Contacts

Simone Oliveira, PhD

Role: primary

simone_s_oliveira@hotmail.com

+55-21-991245952

Other Identifiers

Simone

Identifier Type: -

Identifier Source: org_study_id