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

Official title

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

Overview

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.

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.

Primary outcome measures

• Splint wear (volumetric material loss) [Time frame: 3 months]

Secondary outcome measures (1)

• Patient-reported satisfaction and oral health-related quality of life (OHIP-derived questionnaire) [Time frame: Baseline and 3 months]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Başkent University, Faculty of Dentistry — Ankara

Publications

• Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11. PMID 8193981
• Hardy RS, Bonsor SJ. The efficacy of occlusal splints in the treatment of bruxism: A systematic review. J Dent. 2021 May;108:103621. doi: 10.1016/j.jdent.2021.103621. Epub 2021 Feb 27. PMID 33652054
• Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21. PMID 29926505

Identifiers

NCT: NCT07433725 · D-KA25/36 · D-KA25/36

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗