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

NCT07433725 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-25

No results posted yet for this 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.

Conditions

  • Bruxism, Sleep

Interventions

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.

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Principal Investigators

  • Hale Arıkan Kalaycı, Assistant Professor · Başkent University, Faculty of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07433725 on ClinicalTrials.gov