Temporomandibular Joint DysfunctionMRITMJNCT02294799
Magnetic Ressonance Imaging of Temporomandibular Joint
A study testing Intervention Group in people with Temporomandibular Joint Dysfunction, run by Daniela Ap. Biasotto-Gonzalez at 1 site in Brazil.
Trial summary
Background: Among the instrumental devices that have been proposed over the years to integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging techniques are the most studied, showing that magnetic resonance imaging (MRI) is the technique most need to describe the anatomy of the TMJ and to… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- TMD diagnosed subjects by RDC / TMD confirmed by the MRI findings,
- with anterior disk displacement with or without reduction,
- with full dentition (excluding third molars).
Who cannot join
- Subjects diagnosed TMD exclusively muscular;
- with posterior and / or medial displacement of the disc;
- showing systemic diseases that affect the joints and / or masticatory muscles;
- neuromuscular diseases;
- hypo / condylar hyperplasia;
- making use of any type of dental prosthesis;
Show all 9Show fewer
- are in orthodontic and / or physical therapy;
- showing neurological or behavioral disorders that preclude the achievement of MRI and/or
- a history of previous TMJ surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Magnetic Ressonance Imaging Evaluation of Articular Disc Position in TMD Subjects After Mandibular Mobilization. A Double Blind, Randomized, Placebo-controlled Study
Background: Among the instrumental devices that have been proposed over the years to integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging techniques are the most studied, showing that magnetic resonance imaging (MRI) is the technique most need to describe the anatomy of the TMJ and to evaluate the correlation of imaging findings with the clinical diagnosis . Despite the amount available studies on the use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of nonspecific mandibular mobilization about the positioning of the articular disc by MRI in individuals with TMD diagnosis of anterior disc displacement with and without reduction according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline and after each treatment session, the quality of life of individuals with TMD at baseline, immediately, three and six months after the treatment sessions by the World Health Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed three times a week during four weeks. Metodology: This is a randomized, placebo controlled, blind study designed to assess the effects of techniques nonspecific mandibular mobilization x placebo. Individuals will be randomized and divided into two groups: Group A (intervention) and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted through the use of MRI, will be considered the primary outcome and, as a secondary outcome will be assessed the quality of life, pain and function after treatment. The adherence of the data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as mean values and standard deviation. Two-way repeated measures analysis of variance with Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance level is adjusted p ≤ 0.05.
Read the detailed description
This is a randomized, placebo-controlled, double-blind study designed to verify the effects of nonspecific mandibular mobilization techniques x placebo
- Conditions
- Temporomandibular Joint Dysfunction
- Being tested
- Intervention Group, Placebo group
- Keywords
- Temporomandibular Joint Disorders, Magnetic Ressonance Imaging, Complementary Therapy, Physical Therapy Modalities.
- 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.
Intervention GroupOther
Also called Mandibular Mobilization
Grade 1, Nonspecific Mandibular Mobilization
Placebo groupOther
Also called Placebo Mandibular Mobilization
Nonspecific Mandibular Movement.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Other | TMD diagnosed sujects that will receive the mobilization treatment Receives: Other: Intervention Group |
| Placebo Group | Placebo comparator | TMD diagnosed sujects that will receive the placebo treatment Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)
Measured by the Magnetic Ressonance Imaging
Measured: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Secondary outcomes (3)
Clinical Symptoms (Measured by END)
Measured by numerical scale of pain assessment (END)
Measured: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)
Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012
Measured: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Quality of life (Whoqol-bref)
Whoqol-bref
Measured: Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DysfunctionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniela Ap. Biasotto-Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
- Investigators
- Daniela Ap Biasotto-Gonzalez, PHD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294799
- Sponsor's protocol ID
- YEH1984
- Acronym
- MRITMJ
- Status last verified
- Feb 2025
- First submitted
- 9 Apr 2013
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmad M, Hollender L, Anderson Q, Kartha K, Ohrbach R, Truelove EL, John MT, Schiffman EL. Research diagnostic criteria for temporomandibular disorders (RDC/TMD): development of image analysis criteria and examiner reliability for image analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jun;107(6):844-60. doi: 10.1016/j.tripleo.2009.02.023.
PubMed 19464658de Lucena LB, Kosminsky M, da Costa LJ, de Goes PS. Validation of the Portuguese version of the RDC/TMD Axis II questionnaire. Braz Oral Res. 2006 Oct-Dec;20(4):312-7. doi: 10.1590/s1806-83242006000400006.
PubMed 17242791Gray RJ, Quayle AA, Hall CA, Schofield MA. Physiotherapy in the treatment of temporomandibular joint disorders: a comparative study of four treatment methods. Br Dent J. 1994 Apr 9;176(7):257-61. doi: 10.1038/sj.bdj.4808429.
PubMed 8186034Furto ES, Cleland JA, Whitman JM, Olson KA. Manual physical therapy interventions and exercise for patients with temporomandibular disorders. Cranio. 2006 Oct;24(4):283-91. doi: 10.1179/crn.2006.044.
PubMed 17086858Ohnuki T, Fukuda M, Nakata A, Nagai H, Takahashi T, Sasano T, Miyamoto Y. Evaluation of the position, mobility, and morphology of the disc by MRI before and after four different treatments for temporomandibular joint disorders. Dentomaxillofac Radiol. 2006 Mar;35(2):103-9. doi: 10.1259/dmfr/25020275.
PubMed 16549437Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012 Jan;42(1):30-42. doi: 10.2519/jospt.2012.3727. Epub 2011 Oct 25.
PubMed 22031594Aigner M, Forster-Streffleur S, Prause W, Freidl M, Weiss M, Bach M. What does the WHOQOL-Bref measure? Measurement overlap between quality of life and depressive symptomatology in chronic somatoform pain disorder. Soc Psychiatry Psychiatr Epidemiol. 2006 Jan;41(1):81-6. doi: 10.1007/s00127-005-0997-8. Epub 2006 Jan 1.
PubMed 16341612El Hage Y, Politti F, de Sousa DF, Herpich CM, Gloria IP, Gomes CA, Amaral AP, de Melo NC, da Silva TC, Arruda EE, Amorim CF, Gadotti IC, Gonzalez TO, Berzin F, Bussadori SK, Garcia MB, Barbosa BR, Biasotto-Gonzalez DA. Effect of mandibular mobilization on electromyographic signals in muscles of mastication and static balance in individuals with temporomandibular disorder: study protocol for a randomized controlled trial. Trials. 2013 Oct 1;14:316. doi: 10.1186/1745-6215-14-316.
PubMed 24083628Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
PubMed 21856077Emshoff R, Brandlmaier I, Gerhard S, Strobl H, Bertram S, Rudisch A. Magnetic resonance imaging predictors of temporomandibular joint pain. J Am Dent Assoc. 2003 Jun;134(6):705-14. doi: 10.14219/jada.archive.2003.0256.
PubMed 12839406Emara AS, Faramawey MI, Hassaan MA, Hakam MM. Botulinum toxin injection for management of temporomandibular joint clicking. Int J Oral Maxillofac Surg. 2013 Jun;42(6):759-64. doi: 10.1016/j.ijom.2013.02.009. Epub 2013 Mar 26.
PubMed 23538215
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Ressonance Imaging Evaluation of Articular Disc Position in TMD Subjects After Mandibular Mobilization. A Double Blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02294799
- Acronym / sponsor ID
- MRITMJ / YEH1984
- Conditions
- Temporomandibular Joint Dysfunction
- Keywords
- Temporomandibular Joint Disorders, Magnetic Ressonance Imaging, Complementary Therapy, Physical Therapy Modalities.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Daniela Ap. Biasotto-GonzalezUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Nov 2014 (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.
Background: Among the instrumental devices that have been proposed over the years to integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging techniques are the most studied, showing that magnetic resonance imaging (MRI) is the technique most need to describe the anatomy of the TMJ and to evaluate the correlation of imaging findings with the clinical diagnosis . Despite the amount available studies on the use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of nonspecific mandibular mobilization about the positioning of the articular disc by MRI in individuals with TMD diagnosis of anterior disc displacement with and without reduction according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline and after each treatment session, the quality of life of individuals with TMD at baseline, immediately, three and six months after the treatment sessions by the World Health Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed three times a week during four weeks. Metodology: This is a randomized, placebo controlled, blind study designed to assess the effects of techniques nonspecific mandibular mobilization x placebo. Individuals will be randomized and divided into two groups: Group A (intervention) and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted through the use of MRI, will be considered the primary outcome and, as a secondary outcome will be assessed the quality of life, pain and function after treatment. The adherence of the data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as mean values and standard deviation. Two-way repeated measures analysis of variance with Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance level is adjusted p ≤ 0.05.
Detailed description
This is a randomized, placebo-controlled, double-blind study designed to verify the effects of nonspecific mandibular mobilization techniques x placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Other: Intervention GroupTMD diagnosed sujects that will receive the mobilization treatment |
| Placebo Group | Placebo comparator | Other: Placebo groupTMD diagnosed sujects that will receive the placebo treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- TMD diagnosed subjects by RDC / TMD confirmed by the MRI findings,
- with anterior disk displacement with or without reduction,
- with full dentition (excluding third molars).
Key exclusion criteria (9 listed)
- Subjects diagnosed TMD exclusively muscular;
- with posterior and / or medial displacement of the disc;
- showing systemic diseases that affect the joints and / or masticatory muscles;
- neuromuscular diseases;
- hypo / condylar hyperplasia;
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 |
|---|---|---|
| Intervention GroupAlso: Mandibular MobilizationGrade 1, Nonspecific Mandibular Mobilization | Other | Intervention Group |
| Placebo groupAlso: Placebo Mandibular MobilizationNonspecific Mandibular Movement. | Other | Placebo Group |
Primary outcome
Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)
Time frame: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Measured by the Magnetic Ressonance Imaging
3 secondary outcomes
Clinical Symptoms (Measured by END)
Time frame: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)
Time frame: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Quality of life (Whoqol-bref)
Time frame: Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 19464658Ahmad M, Hollender L, Anderson Q, Kartha K, Ohrbach R, Truelove EL, John MT, Schiffman EL. Research diagnostic criteria for temporomandibular disorders (RDC/TMD): development of image analysis criteria and examiner reliability for image analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jun;107(6):844-60. doi: 10.1016/j.tripleo.2009.02.023.
- Background: PubMed 17242791de Lucena LB, Kosminsky M, da Costa LJ, de Goes PS. Validation of the Portuguese version of the RDC/TMD Axis II questionnaire. Braz Oral Res. 2006 Oct-Dec;20(4):312-7. doi: 10.1590/s1806-83242006000400006.
- Background: PubMed 8186034Gray RJ, Quayle AA, Hall CA, Schofield MA. Physiotherapy in the treatment of temporomandibular joint disorders: a comparative study of four treatment methods. Br Dent J. 1994 Apr 9;176(7):257-61. doi: 10.1038/sj.bdj.4808429.
- Background: PubMed 17086858Furto ES, Cleland JA, Whitman JM, Olson KA. Manual physical therapy interventions and exercise for patients with temporomandibular disorders. Cranio. 2006 Oct;24(4):283-91. doi: 10.1179/crn.2006.044.
- Background: PubMed 16549437Ohnuki T, Fukuda M, Nakata A, Nagai H, Takahashi T, Sasano T, Miyamoto Y. Evaluation of the position, mobility, and morphology of the disc by MRI before and after four different treatments for temporomandibular joint disorders. Dentomaxillofac Radiol. 2006 Mar;35(2):103-9. doi: 10.1259/dmfr/25020275.
- Background: PubMed 22031594Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012 Jan;42(1):30-42. doi: 10.2519/jospt.2012.3727. Epub 2011 Oct 25.
- Background: PubMed 16341612Aigner M, Forster-Streffleur S, Prause W, Freidl M, Weiss M, Bach M. What does the WHOQOL-Bref measure? Measurement overlap between quality of life and depressive symptomatology in chronic somatoform pain disorder. Soc Psychiatry Psychiatr Epidemiol. 2006 Jan;41(1):81-6. doi: 10.1007/s00127-005-0997-8. Epub 2006 Jan 1.
- Background: PubMed 24083628El Hage Y, Politti F, de Sousa DF, Herpich CM, Gloria IP, Gomes CA, Amaral AP, de Melo NC, da Silva TC, Arruda EE, Amorim CF, Gadotti IC, Gonzalez TO, Berzin F, Bussadori SK, Garcia MB, Barbosa BR, Biasotto-Gonzalez DA. Effect of mandibular mobilization on electromyographic signals in muscles of mastication and static balance in individuals with temporomandibular disorder: study protocol for a randomized controlled trial. Trials. 2013 Oct 1;14:316. doi: 10.1186/1745-6215-14-316.
- Background: PubMed 21856077Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
- Background: PubMed 12839406Emshoff R, Brandlmaier I, Gerhard S, Strobl H, Bertram S, Rudisch A. Magnetic resonance imaging predictors of temporomandibular joint pain. J Am Dent Assoc. 2003 Jun;134(6):705-14. doi: 10.14219/jada.archive.2003.0256.
- Background: PubMed 23538215Emara AS, Faramawey MI, Hassaan MA, Hakam MM. Botulinum toxin injection for management of temporomandibular joint clicking. Int J Oral Maxillofac Surg. 2013 Jun;42(6):759-64. doi: 10.1016/j.ijom.2013.02.009. Epub 2013 Mar 26.
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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.
Daniela Ap Biasotto-Gonzalez, PHD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Temporomandibular Joint Dysfunction, run by Daniela Ap. Biasotto-Gonzalez 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 3 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: opening soon, as of the sponsor's last update on 28 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DANIELA AP BIASOTTO-GONZALEZ, PHD (+55 11 36659325, dani_atm@ig.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging) (time frame: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.). 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 NCT02294799, which also lists 11 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 28 Feb 2025.