Abstract
<title>Abstract</title> <p>Background Temporomandibular disorders (TMD) represent a frequently encountered group of conditions that affect the muscles and joints of the stomatognathic system. Patients experiencing TMD present with pain, joint dysfunction, and impaired mandibular function. Stabilization splints are generally used as one of the first-line conservative treatments. Fabrication of conventional splints using heat-cured acrylic resin is technique-sensitive and is susceptible to variability and inaccuracies. In contrast, digital workflows use computer-aided design (CAD) & computer-aided manufacturing (CAM) followed by additive manufacturing may offer improved standardization, reproducibility, precision, and accuracy. Despite these potential advantages, high-quality clinical evidence comparing digitally fabricated and conventional stabilization splints remains limited. Participants & Methodology This is a single-center randomized controlled trial. The trial comprises two parallel groups: a conventional stabilization splint group and a digitally fabricated stabilization splint group. The allocation ratio of participants is 1:1. A blinded assessor will perform outcome assessment. A total of 120 participants will be recruited. The Age group will be 18-40 years. Participants will be screened using Diagnostic Criteria for TMD Axis I (DC/TMD). Participants will be randomly assigned to each group. All splints will be standardized in design and occlusion. The primary outcome is the change in characteristic pain intensity (CPI), which is derived from the Graded Chronic Pain Scale (0–100). The outcomes will be assessed from baseline to three months post-intervention. Secondary outcomes include pain-related disability, maximum mouth opening, jaw functional limitation, temporomandibular joint clicking, oral health-related quality of life, and Patient’s compliance. Participants’ data will be analyzed according to their original group allocation. It will be independent to treatment adherence or abandonment from the intervention. Primary outcome analysis will be done using Linear mixed-effects models. Discussion The objective of this trial is to provide strong clinical evidence on the comparative efficacy of digitally fabricated and conventional stabilization splints in the management of TMD. The findings may contribute to evidence-based decision-making. It will also support the integration of digital technologies into routine conservative management of TMD. Trial registration: Prospectively Registered at ClinicalTrials.gov. Trial registry number is (NCT07566936)</p>