Temporomandibular Joint DisordersSimoneNCT02490605
Effect of the Use of an Occlusal Plate on the Postural Alignment
A study testing occlusal plate group and therapeutic exercises in people with Temporomandibular Joint Disorders, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- occlusal plate group and therapeutic exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- Patients with a history of falls,
- Patients with diabetes accompanied by sensitive neuropathies,
- Patients who complain of labyrinthitis.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade de São Paulo
São Paulo, São Paulo, 05508-900
Simone Oliveira, PhD, +55-21-991245952, simone_s_oliveira@hotmail.com
About this study
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
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.
Read the 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
- Being tested
- occlusal plate group, therapeutic exercises
- Keywords
- Postural balance, Temporomandibular disorders, Splints
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal plate groupProcedure or surgery
occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides
therapeutic exercisesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| occlusal plate group | Experimental | 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. Receives: Procedure: occlusal plate group; Procedure: therapeutic exercises |
| therapeutic exercises | Active comparator | 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. Receives: Procedure: therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Luiza Moreira Arantes Frigerio
- Responsible party
- Principal investigator, Simone Saldanha Ignacio de Oliveira, University of Sao Paulo
- Investigators
- Maria Luiza MA Frigerio, PhD, Principal investigator, Universidade de São Paulo - Brazil - 05508-900
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490605
- Sponsor's protocol ID
- Simone
- Acronym
- Simone
- Status last verified
- Jul 2015
- First submitted
- 5 Jun 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02490605
- Acronym / sponsor ID
- Simone / Simone
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Postural balance, Temporomandibular disorders, Splints
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Maria Luiza Moreira Arantes Frigerio
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| occlusal plate group | Experimental | Procedure: occlusal plate group, Procedure: therapeutic exercisesThe 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. |
| therapeutic exercises | Active comparator | Procedure: therapeutic exercisesThe 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occlusal plate groupocclusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides | Procedure or surgery | occlusal plate group |
| therapeutic exercisesThe 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 | Procedure or surgery | occlusal plate group, therapeutic exercises |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luiza MA Frigerio, PhD principal investigator
Universidade de São Paulo - Brazil - 05508-900
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal plate group and therapeutic exercises in people with Temporomandibular Joint Disorders, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Oliveira, PhD (+55-21-991245952, simone_s_oliveira@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the effects of the use of occlusal splint over postural alignment (time frame: twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.