Temporomandibular DisordersEarly Phase 1NCT01150110
Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)
A Early Phase 1 study testing resilient occlusal splints in people with Temporomandibular Disorders, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The purpose of this study was to compare the effectiveness of soft occlusal splint therapy on the electromyographic activity of masticatory muscles (ateriors temporalis and masseter) before and after the application of a muscle relaxation splint. Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- resilient occlusal splints
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Jul 2008
- Phase
- Early Phase 1
- 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 19 to 50 years
- All sexes
- Adult
Who may be able to join
- Patients with clinical and/or diagnosis of TMD
- With complaints of muscle disorders and / or joint pain, pain symptoms
- Presence of occlusal interferences
- Minimum of 20 functional teeth in the oral cavity with subsequent bilateral occlusion
Who cannot join
- Individuals with extensive dental flaws
- Orthodontic treatment in progress
- History of systemic diseases as advanced arthritis, diabetes and conservative and reversible treatments such as occlusal splints are recommended
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Resilient Occlusal Splints in the Control of Patients With Temporomandibular Disorder (TMD)
The purpose of this study was to compare the effectiveness of soft occlusal splint therapy on the electromyographic activity of masticatory muscles (ateriors temporalis and masseter) before and after the application of a muscle relaxation splint. Electromyography recordings from the masseter and anterior temporalis muscles were analyzed quantitatively during maximal clench, rest and mastication usual, before and after the treatment without a splint. Ten patients whose chief complaint was Temporomandibular Disorders (TMD) were selected for the study. After the initial evaluations soft occlusal splints (muscle relaxation splints) were applied, and the patients were instructed to use the splints for four weeks. Surface electromyographic recordings were taken from each patient, as clinical evaluations of TMD (Index of Helkimo), both evaluations before the beginning of clinical therapy and after four weeks of wearing splints. The data obtained were analyzed by Wilcoxon´s and Friedman´s tests.
- Conditions
- Temporomandibular Disorders
- Being tested
- resilient occlusal splints
- Keywords
- Temporomandibular disorders, occlusal splints, electromyography, TMD (muscle and joint dysfunction), masseteres e anterior temporalis muscles.
- Medical subject headings
- Temporomandibular Joint Disorders, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resilient occlusal splintsDevice
A resilient occlusal splints (silicone 2mm) was fabricated on the maxillary arch, using a vacuum pressing machine. The occlusal splints were adjusted to eliminate the gross interferences and to obtain occlusal stability with maximum posterior bilateral contacts.
Patients were instructed to use the occlusal splints for 24 hours during 30 days. The use was interrupted only during meals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJul 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Investigators
- Germana Camargos, academic, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150110
- Sponsor's protocol ID
- 432
- Status last verified
- May 2007
- First submitted
- 23 Jun 2010
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resilient Occlusal Splints in the Control of Patients With Temporomandibular Disorder (TMD)
- ClinicalTrials.gov ID
- NCT01150110
- Acronym / sponsor ID
- 432
- Conditions
- Temporomandibular Disorders
- Keywords
- Temporomandibular disorders, occlusal splints, electromyography, TMD (muscle and joint dysfunction), masseteres e anterior temporalis muscles.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Jun 2010 (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 purpose of this study was to compare the effectiveness of soft occlusal splint therapy on the electromyographic activity of masticatory muscles (ateriors temporalis and masseter) before and after the application of a muscle relaxation splint. Electromyography recordings from the masseter and anterior temporalis muscles were analyzed quantitatively during maximal clench, rest and mastication usual, before and after the treatment without a splint. Ten patients whose chief complaint was Temporomandibular Disorders (TMD) were selected for the study. After the initial evaluations soft occlusal splints (muscle relaxation splints) were applied, and the patients were instructed to use the splints for four weeks. Surface electromyographic recordings were taken from each patient, as clinical evaluations of TMD (Index of Helkimo), both evaluations before the beginning of clinical therapy and after four weeks of wearing splints. The data obtained were analyzed by Wilcoxon´s and Friedman´s tests.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with clinical and/or diagnosis of TMD
- With complaints of muscle disorders and / or joint pain, pain symptoms
- Presence of occlusal interferences
- Minimum of 20 functional teeth in the oral cavity with subsequent bilateral occlusion
Key exclusion criteria (3 listed)
- Individuals with extensive dental flaws
- Orthodontic treatment in progress
- History of systemic diseases as advanced arthritis, diabetes and conservative and reversible treatments such as occlusal splints are recommended
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 |
|---|---|---|
| resilient occlusal splintsA resilient occlusal splints (silicone 2mm) was fabricated on the maxillary arch, using a vacuum pressing machine. The occlusal splints were adjusted to eliminate the gross interferences and to obtain occlusal stability with maximum posterior bilateral contacts. Patients were instructed to use the occlusal splints for 24 hours during 30 days. The use was interrupted only during meals. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
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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.
Germana Camargos, academic principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing resilient occlusal splints in people with Temporomandibular Disorders, run by Federal University of Uberlandia 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 24 Jun 2010. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 24 Jun 2010.