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Recruiting NCT07433725

3D-Printed vs Conventional Acrylic Stabilization Splints in Young Adults With Bruxism and Temporomandibular Disorders: A Randomized Trial

Trial Parameters

Condition Bruxism, Sleep
Sponsor Baskent University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 44
Sex ALL
Min Age 18 Years
Max Age 25 Years
Start Date 2026-01-12
Completion 2026-07
Interventions
3D-Printed Occlusal Splint (Voco V-Print)Conventional Acrylic Occlusal Splint

Brief Summary

This randomized clinical study will compare two occlusal splint (night guard) fabrication methods in adults with bruxism (teeth grinding/clenching). Forty-four participants will be randomly allocated to receive either (1) a 3D-printed splint manufactured from a photopolymer resin (Voco V-Print) or (2) a conventional acrylic splint fabricated using standard techniques. Participants will wear the splint during sleep for 3 months and will follow standardized instructions for use and care. At the 3-month follow-up, patient-reported satisfaction and oral health-related quality of life will be assessed using an OHIP-derived questionnaire, and splint wear will be quantified as volumetric material loss (mm³) by 3D scanning and superimposition. The results will help determine whether 3D-printed splints provide comparable patient-centered outcomes and clinical durability to conventional acrylic splints.

Eligibility Criteria

Inclusion Criteria: * Adults (≥18 years) diagnosed with bruxism (sleep and/or awake bruxism) based on clinical assessment and patient report. Indication for an occlusal splint and willingness to wear the splint during sleep for 3 months. Ability to provide written informed consent and to attend scheduled follow-up visits. Exclusion Criteria: * Current or recent use of an occlusal splint within the last 6 months. Ongoing orthodontic treatment or planned major dental treatment during the study period that could affect occlusion. Severe temporomandibular disorder requiring active treatment (e.g., acute pain, limited mouth opening) or other conditions that could contraindicate splint use. Extensive untreated dental disease requiring immediate care (e.g., severe periodontal disease, multiple untreated caries). Systemic/neurologic conditions or medications that may significantly affect bruxism or neuromuscular function (as judged by the investigator).

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