Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders

Enrolling by invitation · Not applicable

Conditions studied: Temporomandibular Disorders (TMD)

In brief

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.

Key facts

Study ID

NCT07566936

Run by

Shifa Tameer-e-Millat University

People needed

120

Starts

2026-01-01

Expected to finish

2026-10-26

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shifa College of Dentistry — Islamabad, Islamabad, Pakistan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.