Myogenic Temporomandibular Joint DisordersNCT07397013
Adjustment Technique for Occlusal Stabilizing Splint
A study testing Stabilizing Splint(3-point of Contact) and Stabilizing Splint (Centric and Eccentric) in people with Myogenic Temporomandibular Joint Disorders and Internal Derangement of the Tempromandibular Joint, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to clarify the technique of occlusal stabilizing splint adjustment then to assess the overall clinical outcomes and patient satisfaction. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Myogenic Temporomandibular Joint Disorders, Internal Derangement of the Tempromandibular Joint, Temporomandibular Disorders (TMDs)
- What is being tested?
- Stabilizing Splint(3-point of Contact) and Stabilizing Splint (Centric and Eccentric)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 15 Jan 2026
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pain in the orofacial region (either arthrogenous and/or myogenous) in the last 3 months, who never underwent any type of treatment for TMD's.
- Patients with TMJ internal derangement.
- Age ≥16 years.
Who cannot join
- Edentulous patients.
- Patients with any systemic disease that could cause joint and/or muscle changes.
- Patients who undergo drug treatment for the condition.
- Current pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjustment Technique for Occlusal Stabilizing Splint Used in Temporomandibular Disorders. A Clinical Guide
This study aims to clarify the technique of occlusal stabilizing splint adjustment then to assess the overall clinical outcomes and patient satisfaction.
Read the detailed description
It is reasonable to highlight the occlusal stabilizing splint adjustment protocol as it is important to achieve TMDs' sign and symptom relief. Therefore, the objective of this study is to explain in detail how to adjust the occlusal stabilizing splint properly, as we found few studies that clarify the exact adjustment protocol.
- Conditions
- Myogenic Temporomandibular Joint Disorders, Internal Derangement of the Tempromandibular Joint, Temporomandibular Disorders (TMDs), Temporomandibular Joint Disc Displacement
- Being tested
- Stabilizing Splint(3-point of Contact), Stabilizing Splint (Centric and Eccentric)
- Keywords
- TMDs, Myogenic Pain, Intraarticular Pain, Disc Displacement, Stabilizing Splint
- 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.
Stabilizing Splint(3-point of Contact)Device
These devices are also known as flat plane, inter-occlusal splint, or myo relaxation splint, and are used not only to stabilize the TMJ but also protect the teeth, relax masser etand temporalis muscles, increase inter-discal space, allow the balance of bite forces, and decrease bruxism activity.
Stabilizing Splint (Centric and Eccentric)Device
Stabilizing Splint (Centric and Eccentric)
| Study group | Role | What they receive |
|---|---|---|
| Stabilizing Splint (3-point of Contact) | Experimental | Stabilizing Splints were adjusted only in centric relation with at least 3-point of contact Receives: Device: Stabilizing Splint(3-point of Contact) |
| Stabilizing Splint (Centric and Eccentric) | Experimental | Stabilizing Splints were adjusted in centric relation and in all eccentric movements Receives: Device: Stabilizing Splint (Centric and Eccentric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Patient Satisfaction
Using PSPSQ Questionnaire (The patient satisfaction questionnaire comprised three questions assessed using 10-point Likert Scale)
Measured: 6 months after using the stabilizing splint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Jun 2025
- Primary completion1 Sep 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myogenic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Ahmed Haggag, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397013
- Sponsor's protocol ID
- R.26.01.97
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustment Technique for Occlusal Stabilizing Splint Used in Temporomandibular Disorders. A Clinical Guide
- ClinicalTrials.gov ID
- NCT07397013
- Acronym / sponsor ID
- R.26.01.97
- Conditions
- Myogenic Temporomandibular Joint Disorders, Internal Derangement of the Tempromandibular Joint, Temporomandibular Disorders (TMDs), Temporomandibular Joint Disc Displacement
- Keywords
- TMDs, Myogenic Pain, Intraarticular Pain, Disc Displacement, Stabilizing Splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 9 Feb 2026 (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.
This study aims to clarify the technique of occlusal stabilizing splint adjustment then to assess the overall clinical outcomes and patient satisfaction.
Detailed description
It is reasonable to highlight the occlusal stabilizing splint adjustment protocol as it is important to achieve TMDs' sign and symptom relief. Therefore, the objective of this study is to explain in detail how to adjust the occlusal stabilizing splint properly, as we found few studies that clarify the exact adjustment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilizing Splint (3-point of Contact) | Experimental | Device: Stabilizing Splint(3-point of Contact)Stabilizing Splints were adjusted only in centric relation with at least 3-point of contact |
| Stabilizing Splint (Centric and Eccentric) | Experimental | Device: Stabilizing Splint (Centric and Eccentric)Stabilizing Splints were adjusted in centric relation and in all eccentric movements |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pain in the orofacial region (either arthrogenous and/or myogenous) in the last 3 months, who never underwent any type of treatment for TMD's.
- Patients with TMJ internal derangement.
- Age ≥16 years.
Key exclusion criteria (4 listed)
- Edentulous patients.
- Patients with any systemic disease that could cause joint and/or muscle changes.
- Patients who undergo drug treatment for the condition.
- Current pregnancy or breastfeeding.
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 |
|---|---|---|
| Stabilizing Splint(3-point of Contact)These devices are also known as flat plane, inter-occlusal splint, or myo relaxation splint, and are used not only to stabilize the TMJ but also protect the teeth, relax masser etand temporalis muscles, increase inter-discal space, allow the balance of bite forces, and decrease bruxism activity. | Device | Stabilizing Splint (3-point of Contact) |
| Stabilizing Splint (Centric and Eccentric)Stabilizing Splint (Centric and Eccentric) | Device | Stabilizing Splint (Centric and Eccentric) |
Primary outcome
Overall Patient Satisfaction
Time frame: 6 months after using the stabilizing splint
Using PSPSQ Questionnaire (The patient satisfaction questionnaire comprised three questions assessed using 10-point Likert Scale)
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 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Myogenic Temporomandibular Joint Disorders
Not yet recruiting
Manual Therapy vs. Home Exercise in Myogenic TMD With Neck Pain
Temporomandibular Joint Disorders, Neck Pain Musculoskeletal
Not yet recruiting
Efficacy of PRP Injections in Reducing Pain for Myogenous TMD Patients
Myogenic Temporomandibular Joint Disorders, Myofacial Pain
Not yet recruiting
Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder
Temporomandibular Disorders
Recruiting
A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation in Patients With Myogenic Temporomandibular Disorders
Temporomandibular Joint Disorders, Pain
Recruiting
Comparing the Effectiveness of Online vs. Face-to-face Physiotherapy for Treating Temporomandibular Disorders
Temporomandibular Disorders (TMD), Orofacial Pain
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 Stabilizing Splint(3-point of Contact) and Stabilizing Splint (Centric and Eccentric) in people with Myogenic Temporomandibular Joint Disorders and Internal Derangement of the Tempromandibular Joint, run by Mansoura University at 1 site in Egypt.
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 4 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 9 Feb 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 Egypt. 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?
Overall Patient Satisfaction (time frame: 6 months after using the stabilizing splint). 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 9 Feb 2026.