Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders (NCT07566936) | Clinical Trial Compass
By InvitationNot Applicable
Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders
Pakistan120 participantsStarted 2026-01-01
Plain-language summary
This randomized controlled trial aims to compare the clinical effectiveness of digitally fabricated and conventionally fabricated maxillary stabilization splints in patients diagnosed with Temporomandibular Disorders (TMD) according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Participants will be randomly allocated in a 1:1 ratio to receive either a Digitally fabricated splint produced using computer-aided design and three-dimensional printing technology or a conventionally fabricated splint using standard impression and laboratory techniques.
The primary outcome is Change in Pain Intensity measured using the Characteristic Pain Intensity component of the Graded Chronic Pain Scale (GCPS), 0-100 scale. Higher scores indicate greater pain severity from baseline to 3 months as primary end point.
Secondary outcomes include change in pain-related disability assessed using the Graded Chronic Pain Scale (GCPS) disability score, change in maximum mouth opening measured in millimeters (mm), change in jaw functional limitation assessed using the Jaw Functional Limitation Scale (JFLS), resolution of temporomandibular joint (TMJ) clicking (present/absent), change in oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), and compliance with splint use measured as average nightly wear time (hours per night).
Assessments will be conducted at baseline and 3 months post-intervention. Outcome assessment will be performed by a blinded examiner.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Adults aged 18-40 years
* Diagnosis of Temporomandibular Disorder (TMD) according to standardized Diagnostic Criteria for Temporomandibular disorders Axis I
* Maximum unassisted mouth opening between 20-30 mm
* Symptoms present for ≥3 months (to exclude transient/self-limiting cases)
* Willingness to comply with study protocol and provide informed consent
Exclusion Criteria
* Diagnosis of temporomandibular joint myalgia or Myofascial pain as the primary condition
* History of trauma to the temporomandibular joint or mandible
* Presence of degenerative joint diseases (e.g., osteoarthritis, rheumatoid arthritis)
* Congenital or developmental craniofacial anomalies affecting temporomandibular joint
* Prior temporomandibular joint surgery or ongoing orthodontic treatment
* Current use of: Analgesics, muscle relaxants, or anti-inflammatory drugs affecting temporomandibular joint symptoms
* Prior Occlusal splint therapy within the last 3 months
* Systemic conditions affecting joint function (e.g., connective tissue disorders)
* Pregnancy or lactation (if intervention may influence compliance or physiology
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.