Occlusal SplintsNCT06707467
Evaluation of Postural Exercises in the Treatment of Temporomandibular Disorders
A study testing occlusal splint, occlusal splints combined with rocabado exercise and occlusal splint combined with posture exercise in people with Occlusal Splints and Temporomandibular Disorders (TMD), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Fifty-seven patients diagnosed with internal temporomandibular derangement will be included in the study and divided into three groups. All patients will be treated with a proven-effective occlusal splint. The first group will receive only occlusal splint therapy and will serve as the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occlusal Splints, Temporomandibular Disorders (TMD)
- What is being tested?
- occlusal splint, occlusal splints combined with rocabado exercise and occlusal splint combined with posture exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with internal temporomandibular disarrangement
- aged 18 years or older
- Willingness to participate in the study
- Ability to speak and understand Turkish, with no communication difficulties severe enough to impede understanding of the exercises
Who cannot join
- History of acute trauma in the TMJ or surrounding area
- TMJ dysfunction caused by a neurological condition
- History of surgical/invasive procedures or treatments on the TMJ
- Presence of infection or tumoral structures within intraoral structures
- History of tooth loss or use of dental prostheses
- History of surgical procedures in the cervical region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effectiveness of Postural Exercises Combined With Occlusal Splint Therapy in Internal Temporomandibular Derangements
Fifty-seven patients diagnosed with internal temporomandibular derangement will be included in the study and divided into three groups. All patients will be treated with a proven-effective occlusal splint. The first group will receive only occlusal splint therapy and will serve as the control group. The second group will receive occlusal splint therapy combined with Rocabado exercises, while the third group will receive occlusal splint therapy combined with postural exercises.
Before the treatment process, all patients will complete the Temporomandibular Disorders Diagnostic Criteria (TMD-DC) form. Pain intensity will be measured using the Visual Analog Scale (VAS), pain thresholds will be assessed using an algometer, and the following evaluations will be performed: Cervical Posture Assessment (Craniovertebral Angle with Goniometer)-Cervical Range of Motion Assessment (C-ROM)-Cervical Deep Flexor Muscle Endurance Test-Neck Disability Assessment (NDI - Neck Disability Index)-Psychiatric Assessment (HADS - Hospital Anxiety and Depression Scale).
After two months, patients will be recalled, and all tests will be repeated. The effectiveness of the three treatment protocols will then be evaluated.
- Being tested
- occlusal splint, occlusal splints combined with rocabado exercise, occlusal splint combined with posture exercise
- Keywords
- temporomandibular disorders, rocabado, occlusal splints, posture excercise
- 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 splintOther
nineteen patients diagnosed with internal temporomandibular derangement will receive occlusal splint therapy, a treatment method with proven effectiveness.
occlusal splints combined with rocabado exerciseOther
Nineteen patients diagnosed with internal temporomandibular derangement will be provided with Rocabado exercises in addition to the proven-effective treatment method of occlusal splint therapy. This approach aims to evaluate whether Rocabado exercises have a positive effect on the treatment process.
occlusal splint combined with posture exerciseOther
Nineteen patients diagnosed with internal temporomandibular derangement will be provided with posture exercises in addition to the proven-effective treatment method of occlusal splint therapy. This approach aims to evaluate whether posture exercises have a positive effect on the treatment process.
| Study group | Role | What they receive |
|---|---|---|
| nineteen patients with internal temporomandibular disarrangement-group 1 | Experimental | Nineteen randomly selected patients with internal temporomandibular disarrangement Receives: Other: occlusal splints combined with rocabado exercise |
| nineteen patients with internal temporomandibular disarrangement-group 2 | Active comparator | nineteen randomly selected patients with internal temporomanidbular disarrangement Receives: Other: occlusal splint |
| nineteen patients with internal temporomandibular disarrangement-group 3 | Experimental | nineteen selected patients with internal temporomandibular disarrangements Receives: Other: occlusal splint combined with posture exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the Effect of Postural Exercises and Rocabado Exercises on Pain Reduction
Three different treatment protocols will be applied to patients with internal temporomandibular derangement, and the results obtained after a 2-month treatment period will be compared to determine which method is the most effective. To evaluate treatment outcomes, the patients' pre- and post-treatment Visual Analog Scale (VAS) scores will be assessed, with a decrease in the mean VAS score indicating a reduction in pain. Additionally, the pain threshold in various facial regions will be measured with an algometer before and after treatment to identify which treatment protocol is more effective in reducing pain. By combining both outcomes, the most effective method for pain reduction will be determined.
Measured: 2 months
Investigation of the Effect of Postural Exercises and Rocabado Exercises on Physiological Movements
Changes in cervical range of motion (C-ROM) and the craniovertebral angle will also be evaluated to determine the impact of the treatment methods on these parameters. In this way, the method that is more effective in improving physiological movements will be identified.
Measured: 2 months
Secondary outcomes (2)
Investigation of the Secondary Effects of Postural Exercises and Rocabado Exercises on Patient's Psychology
The effect of the treatment protocols applied to the three different groups on the general psychology of the patients will be measured using the Hospital Anxiety and Depression Scale (HADS). In this test, a higher score indicates a higher level of depressive symptoms, and a successful treatment is expected to result in a decrease in the test score.
Measured: 2 months
Investigation of the Effect of Postural Exercises and Rocabado Exercises on the Mobility of the Neck and Jaw
The patient's neck movements will be assessed, and the range of jaw movements will be evaluated. The study aims to identify which treatment protocol leads to the most significant improvement in jaw and neck mobility.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusal SplintsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with internal temporomandibular derangement are divided into three groups. The first group receives only occlusal splint therapy. The second group undergoes occlusal splint therapy combined with Rocabado exercises, while the third group is treated with occlusal splint therapy combined with postural exercises. The effectiveness of the treatment protocols is evaluated.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Bandırma Onyedi Eylül University
- Responsible party
- Principal investigator, Berk Bilgen, Istanbul University
- Investigators
- Ebru K Mutlu, Clinical Prof., Study director, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707467
- Sponsor's protocol ID
- 2023-186
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effectiveness of Postural Exercises Combined With Occlusal Splint Therapy in Internal Temporomandibular Derangements
- ClinicalTrials.gov ID
- NCT06707467
- Acronym / sponsor ID
- 2023-186
- Keywords
- temporomandibular disorders, rocabado, occlusal splints, posture excercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Bandırma Onyedi Eylül University
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 27 Nov 2024 (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.
Fifty-seven patients diagnosed with internal temporomandibular derangement will be included in the study and divided into three groups. All patients will be treated with a proven-effective occlusal splint. The first group will receive only occlusal splint therapy and will serve as the control group. The second group will receive occlusal splint therapy combined with Rocabado exercises, while the third group will receive occlusal splint therapy combined with postural exercises.
Before the treatment process, all patients will complete the Temporomandibular Disorders Diagnostic Criteria (TMD-DC) form. Pain intensity will be measured using the Visual Analog Scale (VAS), pain thresholds will be assessed using an algometer, and the following evaluations will be performed: Cervical Posture Assessment (Craniovertebral Angle with Goniometer)-Cervical Range of Motion Assessment (C-ROM)-Cervical Deep Flexor Muscle Endurance Test-Neck Disability Assessment (NDI - Neck Disability Index)-Psychiatric Assessment (HADS - Hospital Anxiety and Depression Scale).
After two months, patients will be recalled, and all tests will be repeated. The effectiveness of the three treatment protocols will then be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with internal temporomandibular derangement are divided into three groups. The first group receives only occlusal splint therapy. The second group undergoes occlusal splint therapy combined with Rocabado exercises, while the third group is treated with occlusal splint therapy combined with postural exercises. The effectiveness of the treatment protocols is evaluated.
| Arm | Type | Receives |
|---|---|---|
| nineteen patients with internal temporomandibular disarrangement-group 1 | Experimental | Other: occlusal splints combined with rocabado exerciseNineteen randomly selected patients with internal temporomandibular disarrangement |
| nineteen patients with internal temporomandibular disarrangement-group 2 | Active comparator | Other: occlusal splintnineteen randomly selected patients with internal temporomanidbular disarrangement |
| nineteen patients with internal temporomandibular disarrangement-group 3 | Experimental | Other: occlusal splint combined with posture exercisenineteen selected patients with internal temporomandibular disarrangements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with internal temporomandibular disarrangement
- aged 18 years or older
- Willingness to participate in the study
- Ability to speak and understand Turkish, with no communication difficulties severe enough to impede understanding of the exercises
Key exclusion criteria (6 listed)
- History of acute trauma in the TMJ or surrounding area
- TMJ dysfunction caused by a neurological condition
- History of surgical/invasive procedures or treatments on the TMJ
- Presence of infection or tumoral structures within intraoral structures
- History of tooth loss or use of dental prostheses
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 splintnineteen patients diagnosed with internal temporomandibular derangement will receive occlusal splint therapy, a treatment method with proven effectiveness. | Other | nineteen patients with internal temporomandibular disarrangement-group 2 |
| occlusal splints combined with rocabado exerciseNineteen patients diagnosed with internal temporomandibular derangement will be provided with Rocabado exercises in addition to the proven-effective treatment method of occlusal splint therapy. This approach aims to evaluate whether Rocabado exercises have a positive effect on the treatment process. | Other | nineteen patients with internal temporomandibular disarrangement-group 1 |
| occlusal splint combined with posture exerciseNineteen patients diagnosed with internal temporomandibular derangement will be provided with posture exercises in addition to the proven-effective treatment method of occlusal splint therapy. This approach aims to evaluate whether posture exercises have a positive effect on the treatment process. | Other | nineteen patients with internal temporomandibular disarrangement-group 3 |
Primary outcome
Investigation of the Effect of Postural Exercises and Rocabado Exercises on Pain Reduction
Time frame: 2 months
Three different treatment protocols will be applied to patients with internal temporomandibular derangement, and the results obtained after a 2-month treatment period will be compared to determine which method is the most effective. To evaluate treatment outcomes, the patients' pre- and post-treatment Visual Analog Scale (VAS) scores will be assessed, with a decrease in the mean VAS score indicating a reduction in pain. Additionally, the pain threshold in various facial regions will be measured with an algometer before and after treatment to identify which treatment protocol is more effective in reducing pain. By combining both outcomes, the most effective method for pain reduction will be determined.
Investigation of the Effect of Postural Exercises and Rocabado Exercises on Physiological Movements
Time frame: 2 months
Changes in cervical range of motion (C-ROM) and the craniovertebral angle will also be evaluated to determine the impact of the treatment methods on these parameters. In this way, the method that is more effective in improving physiological movements will be identified.
2 secondary outcomes
Investigation of the Secondary Effects of Postural Exercises and Rocabado Exercises on Patient's Psychology
Time frame: 2 months
Investigation of the Effect of Postural Exercises and Rocabado Exercises on the Mobility of the Neck and Jaw
Time frame: 2 month
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 21 Jan 2026.
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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.
Ebru K Mutlu, Clinical Prof. study director
Bandırma Onyedi Eylül University
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, occlusal splints combined with rocabado exercise and occlusal splint combined with posture exercise in people with Occlusal Splints and Temporomandibular Disorders (TMD), run by Istanbul 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 4 inclusion and 6 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 21 Jan 2026. 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?
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.
What does the primary outcome measure?
Investigation of the Effect of Postural Exercises and Rocabado Exercises on Pain Reduction (time frame: 2 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?
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 21 Jan 2026.