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

Baskent University

Status: Enrolling

Conditions: Bruxism, Sleep

Treatments: Device: Conventional Acrylic Occlusal Splint; Device: 3D-Printed Occlusal Splint (Voco V-Print)

Study type: Interventional

Funder types: Other

Identifiers

NCT07433725

D-KA25/36 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

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

Experimental group

Description:

Participants will receive a custom-made occlusal splint fabricated by 3D printing using a photopolymer resin (Voco V-Print) following a standardized clinical workflow. The splint will be delivered and adjusted as needed and worn during sleep for 3 months.

Treatment:

Device: 3D-Printed Occlusal Splint (Voco V-Print)

Device: Conventional Acrylic Occlusal Splint

Conventional Acrylic Occlusal Splint

Active Comparator group

Description:

Participants will receive a custom-made conventional occlusal splint fabricated from acrylic resin using standard laboratory techniques. The splint will be delivered and adjusted as needed and worn during sleep for 3 months.

Treatment:

Device: 3D-Printed Occlusal Splint (Voco V-Print)

Device: Conventional Acrylic Occlusal Splint