NCT07433725

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

Clinical Performance of Stabilization Splints Produced With a 3D Printer in the Treatment of Bruxism and Temporomandibular Disorders

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Baskent University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Occlusal splints are commonly used to manage symptoms associated with bruxism. With the growing adoption of digital workflows, 3D-printed splints have become an alternative to conventional acrylic splints; however, evidence comparing patient-centered outcomes and clinical durability between these approaches remains limited. This study is designed to compare a 3D-printed photopolymer-based occlusal splint (Voco V-Print) with a conventionally fabricated acrylic occlusal splint in adults diagnosed with bruxism. In this randomized clinical study, eligible participants will be assigned to one of two splint fabrication approaches. All participants will receive a custom-made occlusal splint delivered according to standardized clinical procedures and will be instructed to wear the splint during sleep for approximately three months, following standardized use and care instructions. Follow-up assessments will be performed at the end of the study period to capture patient-reported outcomes and clinical performance. Patient-reported satisfaction and oral health-related quality of life will be evaluated using an OHIP-derived questionnaire administered at the follow-up visit. Clinical durability will be assessed by quantifying splint wear as volumetric material loss. For this purpose, each splint will be digitized by 3D scanning at baseline (after fabrication/delivery) and again at follow-up. The two scans will be aligned using a standardized superimposition procedure, and volumetric loss (mm³) will be calculated to quantify wear. The study will provide comparative data on whether 3D-printed splints offer similar patient experience and material performance to conventional acrylic splints over a short-term clinical use period.

Conditions

• Bruxism, Sleep

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Turkey (Türkiye)