3D-Printed vs Conventional Acrylic Stabilization Splints in Young Adults With Bruxism and Temporomandibular Disorders: A Randomized Trial
3D PRINTED
Clinical Performance of Stabilization Splints Produced With a 3D Printer in the Treatment of Bruxism and Temporomandibular Disorders
1 other identifier
interventional
44
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2026
CompletedFirst Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
CompletedFebruary 25, 2026
February 1, 2026
6 months
February 19, 2026
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Splint wear (volumetric material loss)
Volumetric material loss of the occlusal splint (mm³) over 3 months. Each splint will be 3D scanned at baseline (after delivery) and at the 3-month follow-up. Baseline and follow-up scans will be aligned using a standardized superimposition procedure, and the volume difference will be calculated to quantify wear.
3 months
Secondary Outcomes (1)
Patient-reported satisfaction and oral health-related quality of life (OHIP-derived questionnaire)
Baseline and 3 months
Study Arms (2)
3D-Printed Occlusal Splint (Voco V-Print)
EXPERIMENTALParticipants 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.
Conventional Acrylic Occlusal Splint
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Başkent University, Faculty of Dentistry
Ankara, 06490, Turkey (Türkiye)
Related Publications (3)
Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
PMID: 8193981RESULTHardy 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: 33652054RESULTLobbezoo 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: 29926505RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hale Arıkan Kalaycı, Assistant Professor
Başkent University, Faculty of Dentistry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and treating clinicians are not blinded due to the nature of the interventions. Volumetric wear analysis based on 3D scans is performed by an outcome assessor blinded to group allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 19, 2026
First Posted
February 25, 2026
Study Start
January 12, 2026
Primary Completion
July 1, 2026
Study Completion
August 1, 2026
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Beginning 6 months after publication and continuing for 5 years.
- Access Criteria
- Researchers with a methodologically sound proposal for academic, non-commercial purposes.
De-identified individual participant data (IPD) underlying the results reported in this study will be made available to qualified researchers upon reasonable request. Requests will be reviewed by the study team and the institution, and access may require approval by the ethics committee and/or a data use agreement. Only anonymized data will be shared, and no direct identifiers will be provided.