Bruxism, Sleep3D PRINTEDNCT07433725
3D-Printed vs Conventional Acrylic Stabilization Splints in Young Adults With Bruxism and Temporomandibular Disorders: A Randomized Trial
A study testing 3D-Printed Occlusal Splint (Voco V-Print) and Conventional Acrylic Occlusal Splint in people with Bruxism, Sleep, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Bruxism, Sleep
- What is being tested?
- 3D-Printed Occlusal Splint (Voco V-Print) and Conventional Acrylic Occlusal Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başkent University, Faculty of Dentistry
Ankara, 06490
Hale Arıkan Kalaycı, Assistant Professor, +903122466666, halearikan@baskent.edu.tr
About this study
Official title: Clinical Performance of Stabilization Splints Produced With a 3D Printer in the Treatment of Bruxism and Temporomandibular Disorders
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.
Read the 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.
- Conditions
- Bruxism, Sleep
- Being tested
- 3D-Printed Occlusal Splint (Voco V-Print), Conventional Acrylic Occlusal Splint
- Keywords
- occlusal splint
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Occlusal Splint (Voco V-Print)Device
Also called Occlusal Splint, Stabilization Splint, Michigan Splint
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.
Conventional Acrylic Occlusal SplintDevice
Also called Stabilization splint, Michigan 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 3D-Printed Occlusal Splint (Voco V-Print); Device: Conventional Acrylic Occlusal Splint |
| 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. Receives: Device: 3D-Printed Occlusal Splint (Voco V-Print); Device: Conventional Acrylic Occlusal Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start12 Jan 2026
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bruxism, SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale Arıkan Kalaycı, Baskent University
- Investigators
- Hale Arıkan Kalaycı, Assistant Professor, Study director, Başkent University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433725
- Sponsor's protocol ID
- D-KA25/36
- Other IDs
- D-KA25/36
- Acronym
- 3D PRINTED
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
PubMed 8193981Hardy 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.
PubMed 33652054Lobbezoo 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.
PubMed 29926505
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Stabilization Splints Produced With a 3D Printer in the Treatment of Bruxism and Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT07433725
- Acronym / sponsor ID
- 3D PRINTED / D-KA25/36
- Conditions
- Bruxism, Sleep
- Keywords
- occlusal splint
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Occlusal Splint (Voco V-Print) | Experimental | Device: 3D-Printed Occlusal Splint (Voco V-Print), Device: Conventional Acrylic Occlusal SplintParticipants 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 comparator | Device: 3D-Printed Occlusal Splint (Voco V-Print), Device: Conventional Acrylic Occlusal SplintParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Printed Occlusal Splint (Voco V-Print)Also: Occlusal Splint, Stabilization Splint, Michigan SplintCustom-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 | 3D-Printed Occlusal Splint (Voco V-Print), Conventional Acrylic Occlusal Splint |
| Conventional Acrylic Occlusal SplintAlso: Stabilization splint, Michigan SplintCustom-made conventional acrylic occlusal splint fabricated using standard techniques and delivered with standardized instructions for use and care. Worn during sleep for 3 months. | Device | 3D-Printed Occlusal Splint (Voco V-Print), Conventional Acrylic Occlusal Splint |
Primary outcome
Splint wear (volumetric material loss)
Time frame: 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.
1 secondary outcome
Patient-reported satisfaction and oral health-related quality of life (OHIP-derived questionnaire)
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Results publication: PubMed 8193981Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
- Results publication: PubMed 33652054Hardy 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.
- Results publication: PubMed 29926505Lobbezoo 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.
- General information about the study and recruitment contact at Başkent University, Faculty of Dentistry (Ankara, Turkey).Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hale Arıkan Kalaycı, Assistant Professor study director
Başkent University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Occlusal Splint (Voco V-Print) and Conventional Acrylic Occlusal Splint in people with Bruxism, Sleep, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hale Arıkan Kalaycı, Assistant Professor (+903122466666, halearikan@baskent.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splint wear (volumetric material loss) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07433725, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.