Digital vs Conventional Stabilizing Splints in Temporomandibular Disorders

概要

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.