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Clinical Trials in Turkey / NCT07433725
Recruiting Not applicable

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

NCT07433725 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-12
Last updated
2026-02-25

Condition(s) studied

Bruxism, Sleep

Investigational drug(s) / intervention(s)

3D-Printed Occlusal Splint (Voco V-Print)Conventional Acrylic Occlusal Splint

3D-Printed Occlusal Splint (Voco V-Print): Custom-made occlusal splint manufactured by 3D printing using a photopolymer resin (Voco V-Print) and delivered with standardized instructions for use and care. Worn during sleep for 3 months.

Conventional Acrylic Occlusal Splint: Custom-made conventional acrylic occlusal splint fabricated using standard techniques and delivered with standardized instructions for use and care. Worn during sleep for 3 months.

Study 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

Sex
ALL
Min age
18 Years
Max age
25 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Başkent University, Faculty of Dentistry Ankara Turkey (Türkiye) Recruiting

More Baskent University trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07433725 on ClinicalTrials.gov ↗ ← All trials in Turkey