NCT07433725 3D-Printed vs Conventional Acrylic Stabilization Splints in Young Adults With Bruxism and Temporomandibular Disorders: A Randomized Trial
| NCT ID | NCT07433725 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baskent University |
| Condition | Bruxism, Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2026-01-12 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Hale Arıkan Kalaycı, Assistant Professor
STUDY DIRECTOR
Başkent University, Faculty of Dentistry
Frequently Asked Questions
Who can join the NCT07433725 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 25 Years, studying Bruxism, Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07433725 currently recruiting?
Yes, NCT07433725 is actively recruiting participants. Contact the research team at halearikan@baskent.edu.tr for enrollment information.
Where is the NCT07433725 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07433725 clinical trial?
NCT07433725 is sponsored by Baskent University. The principal investigator is Hale Arıkan Kalaycı, Assistant Professor at Başkent University, Faculty of Dentistry. The trial plans to enroll 44 participants.