Temporomandibular Joint DisordersNCT02397070
Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients
A study testing Jaw exercise program and Occlusal Splint and counseling in people with Temporomandibular Joint Disorders and Musculoskeletal Diseases, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial summary
This study evaluates the effect of jaw exercise therapy in the treatment of temporomandibular disorder patients (TMD). An eligible group of patients will be treated with that therapy (experimental group) and another group will be treated with counseling and occlusal splint (control group), considered the standard… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Temporomandibular Joint Disorders, Musculoskeletal Diseases
- What is being tested?
- Jaw exercise program and Occlusal Splint and counseling
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Jul 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females, aged 20-45 years, clinical diagnosis of muscular TMD form mild to moderate according to the Criteria of the Diagnostic and Research of TMD (RDC / TMD), good reception and understanding of spoken Portuguese, able to provide a informed consent, and be available to attend the evaluation returns.
Who cannot join
- Rheumatic, vascular, neurological, infectious or neoplastic disease, cognitive or motor problems, pregnancy status or use of abusive drugs, chronic facial pain history (2 years or more), refuses to participate in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Ceara
Fortaleza, Ceará, 60430-160
Jose ET Rocha, Master, 55 88 99353502, eugeniorocha@hotmail.com
About this study
This study evaluates the effect of jaw exercise therapy in the treatment of temporomandibular disorder patients (TMD). An eligible group of patients will be treated with that therapy (experimental group) and another group will be treated with counseling and occlusal splint (control group), considered the standard therapy for TMD.
Read the detailed description
Mandibular exercises may have behavioral and cognitive action, educating the patient and serving as an instrument of control of parafunctional activity. It is a simple, easy, which seeks adherence to treatment and has negligible cost. A disadvantage is the need of motivation and discipline of the patient in carrying out the therapy daily. The occlusal splints, associated with educational guidance and counseling have world indication the possibility of promoting teeth protection, joint decompression, equalization of electromyographic activity, conscious control of parafunctional activity and strong placebo effect.
- Being tested
- Jaw exercise program, Occlusal Splint and counseling
- Keywords
- Jaw exercise, Occlusal splint, Treatment, Muscular pain, Mandibular movement
- Medical subject headings
- Temporomandibular Joint Disorders, Musculoskeletal Diseases, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaw exercise programProcedure or surgery
The jaw exercise program will consist of three cycles: 1st CYCLE - simple opening and closing mouth, right and left lateral excursions with mechanisms of proprioceptive neuromuscular facilitation and muscle coordination; 2 ° CYCLE - opening and closing exercises, right and left lateral excursions with a counter-resistance force imposed by the participant, with reciprocal inhibition, stretching, and muscular endurance mechanisms; 3rd CYCLE - specific exercises to disk capture attempt in cases of disk displacement with reduction and acute disk displacement without reduction (mouth opening and closing in protrusion) or chronic disk displacement without reduction (forced mouth opening in order to push the disc), with remodeling articulate mechanisms. The conduct will be individualized according to the need and symptoms of patients, which will be monitored fortnightly. It will be proposed 3 times a day, lasting a minute and a half per turn, in front of the mirror, during three months.
Occlusal Splint and counselingDevice
Also called Occlusal appliances,, Occlusal plates
The occlusal splints will be made from obtaining a plaster type IV model of upper arch using alginate and metal stock tray. A 2mm thick polyacetate blade will be adapted to the vacuum device plasticizer, heated and pressed over the previously cut U-shaped plaster model. After cooling, it will be added the self-curing acrylic resin on occlusal surface in order to increase the vertical dimension of occlusion in 2mm (anterior region). After polishing, the splints will be intraorally adjusted using carbon paper and clamp Muller, and installed obtaining maximum tooth contacts in centric relation. The splints will be flat and of full coverage for night use. Patients will be monitored every two weeks for the occlusal adjustment for three months. It will also be done counseling measures through a printed guide in relation to the daily care and the various contributing factors of TMD (diet, stress reduction, elimination of parafunctions and posture correction).
| Study group | Role | What they receive |
|---|---|---|
| Jaw exercise program | Experimental | Not described Receives: Procedure: Jaw exercise program |
| Occlusal splint and counseling | Active comparator | Not described Receives: Device: Occlusal Splint and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular pain
Pain on masticatory muscles (masseter and temporal) pressure, scored 0-3 (0=no pain, 3= severe pain).
Measured: Three months
Articular pain
Pain on bilateral digital pressure on articular region, scored 0-3 (0=no pain, 3= severe pain).
Measured: Three months
Secondary outcomes (2)
Maximum mouth opening
Mouth opening amplitude, measured with a millimeter ruler from the tip of the lower incisors to the tip of the upper incisors, counting the vertical crossover.
Measured: Three months
Mandibular excursions
Lateral and protrusive movement, measured with a millimeter ruler considering the right and left lateral excursion and protrusive excursion.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wagner Araujo de Negrieiros, Universidade Federal do Ceara
- Investigators
- Wagner A Negreiros, PhD, Principal investigator, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397070
- Sponsor's protocol ID
- Federal University of Ceara
- Status last verified
- Mar 2015
- First submitted
- 18 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kraaijenga S, van der Molen L, van Tinteren H, Hilgers F, Smeele L. Treatment of myogenic temporomandibular disorder: a prospective randomized clinical trial, comparing a mechanical stretching device (TheraBite(R)) with standard physical therapy exercise. Cranio. 2014 Jul;32(3):208-16. doi: 10.1179/0886963413Z.00000000016. Epub 2014 Jan 24.
PubMed 25000163Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.
PubMed 22318373Yoda T, Sakamoto I, Imai H, Honma Y, Shinjo Y, Takano A, Tsukahara H, Morita S, Miyamura J, Yoda Y, Sasaki Y, Tomizuka K, Takato T. A randomized controlled trial of therapeutic exercise for clicking due to disk anterior displacement with reduction in the temporomandibular joint. Cranio. 2003 Jan;21(1):10-6. doi: 10.1080/08869634.2003.11746226.
PubMed 12555926Yoshida H, Kashiwagi K, Sakata T, Tanaka M, Kawazoe T, Morita S. Prognostic factor of mandibular condylar movement exercise for patients with internal derangement of the temporomandibular joint on initial presentation: preliminary report. J Craniomaxillofac Surg. 2013 Jul;41(5):356-8. doi: 10.1016/j.jcms.2012.05.009. Epub 2012 Jul 11.
PubMed 22789869
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients
- ClinicalTrials.gov ID
- NCT02397070
- Acronym / sponsor ID
- Federal University of Ceara
- Keywords
- Jaw exercise, Occlusal splint, Treatment, Muscular pain, Mandibular movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 24 Mar 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.
This study evaluates the effect of jaw exercise therapy in the treatment of temporomandibular disorder patients (TMD). An eligible group of patients will be treated with that therapy (experimental group) and another group will be treated with counseling and occlusal splint (control group), considered the standard therapy for TMD.
Detailed description
Mandibular exercises may have behavioral and cognitive action, educating the patient and serving as an instrument of control of parafunctional activity. It is a simple, easy, which seeks adherence to treatment and has negligible cost. A disadvantage is the need of motivation and discipline of the patient in carrying out the therapy daily. The occlusal splints, associated with educational guidance and counseling have world indication the possibility of promoting teeth protection, joint decompression, equalization of electromyographic activity, conscious control of parafunctional activity and strong placebo effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jaw exercise program | Experimental | Procedure: Jaw exercise program |
| Occlusal splint and counseling | Active comparator | Device: Occlusal Splint and counseling |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females, aged 20-45 years, clinical diagnosis of muscular TMD form mild to moderate according to the Criteria of the Diagnostic and Research of TMD (RDC / TMD), good reception and understanding of spoken Portuguese, able to provide a informed consent, and be available to attend the evaluation returns.
Key exclusion criteria (1 listed)
- Rheumatic, vascular, neurological, infectious or neoplastic disease, cognitive or motor problems, pregnancy status or use of abusive drugs, chronic facial pain history (2 years or more), refuses to participate in the study.
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 |
|---|---|---|
| Jaw exercise programThe jaw exercise program will consist of three cycles: 1st CYCLE - simple opening and closing mouth, right and left lateral excursions with mechanisms of proprioceptive neuromuscular facilitation and muscle coordination; 2 ° CYCLE - opening and closing exercises, right and left lateral excursions with a counter-resistance force imposed by the participant, with reciprocal inhibition, stretching, and muscular endurance mechanisms; 3rd CYCLE - specific exercises to disk capture attempt in cases of disk displacement with reduction and acute disk displacement without reduction (mouth opening and closing in protrusion) or chronic disk displacement without reduction (forced mouth opening in order to push the disc), with remodeling articulate mechanisms. The conduct will be individualized according to the need and symptoms of patients, which will be monitored fortnightly. It will be proposed 3 times a day, lasting a minute and a half per turn, in front of the mirror, during three months. | Procedure or surgery | Jaw exercise program |
| Occlusal Splint and counselingAlso: Occlusal appliances,, Occlusal platesThe occlusal splints will be made from obtaining a plaster type IV model of upper arch using alginate and metal stock tray. A 2mm thick polyacetate blade will be adapted to the vacuum device plasticizer, heated and pressed over the previously cut U-shaped plaster model. After cooling, it will be added the self-curing acrylic resin on occlusal surface in order to increase the vertical dimension of occlusion in 2mm (anterior region). After polishing, the splints will be intraorally adjusted using carbon paper and clamp Muller, and installed obtaining maximum tooth contacts in centric relation. The splints will be flat and of full coverage for night use. Patients will be monitored every two weeks for the occlusal adjustment for three months. It will also be done counseling measures through a printed guide in relation to the daily care and the various contributing factors of TMD (diet, stress reduction, elimination of parafunctions and posture correction). | Device | Occlusal splint and counseling |
Primary outcome
Muscular pain
Time frame: Three months
Pain on masticatory muscles (masseter and temporal) pressure, scored 0-3 (0=no pain, 3= severe pain).
Articular pain
Time frame: Three months
Pain on bilateral digital pressure on articular region, scored 0-3 (0=no pain, 3= severe pain).
2 secondary outcomes
Maximum mouth opening
Time frame: Three months
Mandibular excursions
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Results publication: PubMed 25000163Kraaijenga S, van der Molen L, van Tinteren H, Hilgers F, Smeele L. Treatment of myogenic temporomandibular disorder: a prospective randomized clinical trial, comparing a mechanical stretching device (TheraBite(R)) with standard physical therapy exercise. Cranio. 2014 Jul;32(3):208-16. doi: 10.1179/0886963413Z.00000000016. Epub 2014 Jan 24.
- Results publication: PubMed 22318373Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.
- Results publication: PubMed 12555926Yoda T, Sakamoto I, Imai H, Honma Y, Shinjo Y, Takano A, Tsukahara H, Morita S, Miyamura J, Yoda Y, Sasaki Y, Tomizuka K, Takato T. A randomized controlled trial of therapeutic exercise for clicking due to disk anterior displacement with reduction in the temporomandibular joint. Cranio. 2003 Jan;21(1):10-6. doi: 10.1080/08869634.2003.11746226.
- Results publication: PubMed 22789869Yoshida H, Kashiwagi K, Sakata T, Tanaka M, Kawazoe T, Morita S. Prognostic factor of mandibular condylar movement exercise for patients with internal derangement of the temporomandibular joint on initial presentation: preliminary report. J Craniomaxillofac Surg. 2013 Jul;41(5):356-8. doi: 10.1016/j.jcms.2012.05.009. Epub 2012 Jul 11.
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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.
Wagner A Negreiros, PhD principal investigator
Universidade Federal do Ceara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jaw exercise program and Occlusal Splint and counseling in people with Temporomandibular Joint Disorders and Musculoskeletal Diseases, run by Universidade Federal do Ceara 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 1 inclusion and 1 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 24 Mar 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 Wagner A Negreiros, PhD (55 85 91629894, wagnerufc@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular pain (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397070, which also lists 4 linked publications.
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 Mar 2015.