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

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
occlusal plate group
therapeutic exercises
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Postural balance, Temporomandibular disorders, Splints

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

occlusal plate group

therapeutic exercises

Arm Description

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 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.

Outcomes

Primary Outcome Measures

To investigate the effects of the use of occlusal splint over postural alignment
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)

Secondary Outcome Measures

Full Information

First Posted
June 5, 2015
Last Updated
July 1, 2015
Sponsor
University of Sao Paulo
Collaborators
Maria Luiza Moreira Arantes Frigerio
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1. Study Identification

Unique Protocol Identification Number
NCT02490605
Brief Title
Effect of the Use of an Occlusal Plate on the Postural Alignment
Acronym
Simone
Official Title
Effect of the Use of an Occlusal Plate on the Postural Alignment and Balance of Individuals With Signs and Symptoms of Temporomandibular Joint Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Maria Luiza Moreira Arantes Frigerio

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Postural balance, Temporomandibular disorders, Splints

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
occlusal plate group
Arm Type
Experimental
Arm Description
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.
Arm Title
therapeutic exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
occlusal plate group
Intervention Description
occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides
Intervention Type
Procedure
Intervention Name(s)
therapeutic exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
To investigate the effects of the use of occlusal splint over postural alignment
Description
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)
Time Frame
twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Oliveira, PhD
Phone
+55-21-991245952
Email
simone_s_oliveira@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Luiza MA Frigerio, PhD
Organizational Affiliation
Universidade de São Paulo - Brazil - 05508-900
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05508-900
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Oliveira, PhD
Phone
+55-21-991245952
Email
simone_s_oliveira@hotmail.com

12. IPD Sharing Statement

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

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