3D-Printed vs Conventional Acrylic Stabilization Splints in Young Adults With Bruxism and Temporomandibular Disorders: A Randomized Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorBaskent University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years) diagnosed with bruxism (sleep and/or awake bruxism) based on clinical assessment and patient report.

Disqualifiers

Current or recent use of an occlusal splint within the last 6 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: 3D-Printed Occlusal Splint (Voco V-Print)Experimental treatment 2 interventions
Group B: Conventional Acrylic Occlusal SplintActive comparator 2 interventions

Trial outcomes

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.

Time frame
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.

Time frame
Baseline and 3 months

Other outcomes

Sponsors and contacts

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