Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing)TMDNCT04468464
Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging
A study testing Occlusal Splint Treatment and Osteopathic Manual Treatment in people with Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing) and Osteopathy in Temporomandibular Disorders, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to assess the impact of osteopathic manual treatment in patients with an anterior disc displacement over sleep and health quality, pain scores and the movement of the condyle and disc of the temporomandibular joint (TMJ) quantitatively. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing), Osteopathy in Temporomandibular Disorders
- What is being tested?
- Occlusal Splint Treatment and Osteopathic Manual Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2018to 30 Aug 2020
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of TMD (anterior disc displacement)
Who cannot join
- Active orthodontic treatment
- Systemic diseases
- Oral or dental pathologies
- Dental implant placement
- Exodontia within 6 months
- Cranial and cervical trauma or surgery
- Taking antidepressant medication
- Contraindication of MRI scans
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the impact of osteopathic manual treatment in patients with an anterior disc displacement over sleep and health quality, pain scores and the movement of the condyle and disc of the temporomandibular joint (TMJ) quantitatively.
Read the detailed description
Patients with TMD will involve to this study. After having the diagnose in Yeditepe U. Dental Hospital patients will be sent to the Radiology Department. MRI images will be gathered in sagittal, coronal and axial plane for each patient before and after treatment. Volunteers will be divided into two groups; (1) splint therapy for 6 weeks, (2) splint therapy + osteopathy 2 times a week for 6 weeks randomly. At the end of the treatment, patients will be sent to Radiology for the second images. Health Survey and pain scores, Disc condyle angle, disc and condyle displacements will be measured and compared inter and intra groups.
- Conditions
- Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing), Osteopathy in Temporomandibular Disorders
- Being tested
- Occlusal Splint Treatment, Osteopathic Manual Treatment
- Keywords
- temporomandibular disorders, anterior disc displacement with reduction, MRI analyses, Osteopathy
- 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 Splint TreatmentOther
Occlusal splint is used by a dentist during sleep or day time to protect the teeth and temporomandibular joint. Manufactured individually by the technicians according to the dentists measurement procedure.
Osteopathic Manual TreatmentOther
Osteopathy treats the body as a whole and applied by hands over the related structures of the body. TMJ, Cervical, Thoracal, Lumbar vertebra mobilization was applied as well as the fascial and visceral mobilization. Patients also used occlusal splint for 6 weeks during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Occlusal Splint Receives: Other: Occlusal Splint Treatment |
| Study Group | Experimental | Osteopathic Manuel Therapy Receives: Other: Occlusal Splint Treatment; Other: Osteopathic Manual Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Temporomandibular Joint Pain
10 point scale 0- no pain 10- severe pain
Measured: 6 weeks after the first measurement
Change in TMJ MR images
Disc-condyle angle, disc and condyle positions were measured over TMJ images
Measured: 6 weeks after the first measurement
Change in Mandibular Movements
Depression, Left and Right lateralization of the mandibula was measured by the caliper
Measured: 6 weeks after the first measurement
Change in Cervical Movement
Cervical Region range of motions was measured by a goniometer
Measured: 6 weeks after the first measurement
Secondary outcomes (1)
Changes in bodily pain
10 point scale 0- no pain 10- severe pain
Measured: 6 weeks after the first measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start15 Sep 2018
- Primary completion20 Sep 2019
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing)Studies 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
- Model description
- Both groups receive splint treatment, but study group also receives osteopathic manual treatment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468464
- Sponsor's protocol ID
- ACorekci
- Acronym
- TMD
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalamir, A., Pollard, H., Vitiello, A. L., & Bonello, R. (2007). Manual therapy for temporomandibular disorders: A review of the literature. Journal of Bodywork and Movement Therapies, 11(1), 84-90. https://doi.org/10.1016/j.jbmt.2006.07.003
Kurita H, Kurashina K, Ohtsuka A, Kotani A. Change of position of the temporomandibular joint disk with insertion of a disk-repositioning appliance. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Feb;85(2):142-5. doi: 10.1016/s1079-2104(98)90416-4.
PubMed 9503446Gesslbauer C, Vavti N, Keilani M, Mickel M, Crevenna R. Effectiveness of osteopathic manipulative treatment versus osteopathy in the cranial field in temporomandibular disorders - a pilot study. Disabil Rehabil. 2018 Mar;40(6):631-636. doi: 10.1080/09638288.2016.1269368. Epub 2016 Dec 28.
PubMed 28029069
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04468464
- Acronym / sponsor ID
- TMD / ACorekci
- Conditions
- Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing), Osteopathy in Temporomandibular Disorders
- Keywords
- temporomandibular disorders, anterior disc displacement with reduction, MRI analyses, Osteopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 13 Jul 2020 (actual)
- 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 aim of this study is to assess the impact of osteopathic manual treatment in patients with an anterior disc displacement over sleep and health quality, pain scores and the movement of the condyle and disc of the temporomandibular joint (TMJ) quantitatively.
Detailed description
Patients with TMD will involve to this study. After having the diagnose in Yeditepe U. Dental Hospital patients will be sent to the Radiology Department. MRI images will be gathered in sagittal, coronal and axial plane for each patient before and after treatment. Volunteers will be divided into two groups; (1) splint therapy for 6 weeks, (2) splint therapy + osteopathy 2 times a week for 6 weeks randomly. At the end of the treatment, patients will be sent to Radiology for the second images. Health Survey and pain scores, Disc condyle angle, disc and condyle displacements will be measured and compared inter and intra groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Both groups receive splint treatment, but study group also receives osteopathic manual treatment
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Occlusal Splint TreatmentOcclusal Splint |
| Study Group | Experimental | Other: Occlusal Splint Treatment, Other: Osteopathic Manual TreatmentOsteopathic Manuel Therapy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of TMD (anterior disc displacement)
Key exclusion criteria (8 listed)
- Active orthodontic treatment
- Systemic diseases
- Oral or dental pathologies
- Dental implant placement
- Exodontia within 6 months
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 Splint TreatmentOcclusal splint is used by a dentist during sleep or day time to protect the teeth and temporomandibular joint. Manufactured individually by the technicians according to the dentists measurement procedure. | Other | Control Group, Study Group |
| Osteopathic Manual TreatmentOsteopathy treats the body as a whole and applied by hands over the related structures of the body. TMJ, Cervical, Thoracal, Lumbar vertebra mobilization was applied as well as the fascial and visceral mobilization. Patients also used occlusal splint for 6 weeks during the intervention. | Other | Study Group |
Primary outcome
Change in Temporomandibular Joint Pain
Time frame: 6 weeks after the first measurement
10 point scale 0- no pain 10- severe pain
Change in TMJ MR images
Time frame: 6 weeks after the first measurement
Disc-condyle angle, disc and condyle positions were measured over TMJ images
Change in Mandibular Movements
Time frame: 6 weeks after the first measurement
Depression, Left and Right lateralization of the mandibula was measured by the caliper
Change in Cervical Movement
Time frame: 6 weeks after the first measurement
Cervical Region range of motions was measured by a goniometer
1 secondary outcome
Changes in bodily pain
Time frame: 6 weeks after the first measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- BackgroundKalamir, A., Pollard, H., Vitiello, A. L., & Bonello, R. (2007). Manual therapy for temporomandibular disorders: A review of the literature. Journal of Bodywork and Movement Therapies, 11(1), 84-90. https://doi.org/10.1016/j.jbmt.2006.07.003
- Background: PubMed 9503446Kurita H, Kurashina K, Ohtsuka A, Kotani A. Change of position of the temporomandibular joint disk with insertion of a disk-repositioning appliance. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Feb;85(2):142-5. doi: 10.1016/s1079-2104(98)90416-4.
- Background: PubMed 28029069Gesslbauer C, Vavti N, Keilani M, Mickel M, Crevenna R. Effectiveness of osteopathic manipulative treatment versus osteopathy in the cranial field in temporomandibular disorders - a pilot study. Disabil Rehabil. 2018 Mar;40(6):631-636. doi: 10.1080/09638288.2016.1269368. Epub 2016 Dec 28.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Splint Treatment and Osteopathic Manual Treatment in people with Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing) and Osteopathy in Temporomandibular Disorders, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 8 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 13 Jul 2020. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Temporomandibular Joint Pain (time frame: 6 weeks after the first measurement). The study lists 4 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 NCT04468464, which also lists 3 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 13 Jul 2020.