Bruxism, Sleep
Conditions
Keywords
occlusal splint
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.
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
DEVICE3D-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.
DEVICEConventional 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
Baskent University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Splint wear (volumetric material loss) | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported satisfaction and oral health-related quality of life (OHIP-derived questionnaire) | Baseline and 3 months | Patient-reported outcomes will be assessed using an OHIP-derived questionnaire. The questionnaire will be completed at baseline and at the 3-month follow-up; the change in total score (and/or domain scores, if applicable) will be analyzed to compare groups. |
Countries
Turkey (Türkiye)
Contacts
CONTACTHale Arıkan Kalaycı, Assistant Professor
STUDY_DIRECTORHale Arıkan Kalaycı, Assistant Professor
Başkent University, Faculty of Dentistry
Outcome results
None listed