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| ID | Type | Description | Link |
|---|---|---|---|
| D-KA25/36 | Other Grant/Funding Number | Başkent University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-Printed Occlusal Splint (Voco V-Print) | Experimental | 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. |
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| Conventional Acrylic Occlusal Splint | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-Printed Occlusal Splint (Voco V-Print) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported satisfaction and oral health-related quality of life (OHIP-derived questionnaire) | 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. | Baseline and 3 months |
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Inclusion Criteria:
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:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hale Arıkan Kalaycı, Assistant Professor | Contact | +903122466666 | halearikan@baskent.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Hale Arıkan Kalaycı, Assistant Professor | Başkent University, Faculty of Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başkent University, Faculty of Dentistry | Recruiting | Ankara | 06490 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8193981 | Result | Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11. | |
| 33652054 | Result | 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. |
| Label | URL |
|---|---|
| General information about the study and recruitment contact at Başkent University, Faculty of Dentistry (Ankara, Turkey). | View source |
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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.
Beginning 6 months after publication and continuing for 5 years.
Researchers with a methodologically sound proposal for academic, non-commercial purposes.
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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.
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| Conventional Acrylic Occlusal Splint | Device | 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. |
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| 29926505 | Result | 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. |
| ID | Term |
|---|---|
| D020186 | Sleep Bruxism |
| ID | Term |
|---|---|
| D002012 | Bruxism |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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