3D-printed versus conventional acrylic night guards for young adults with bruxism and TMJ problems

Clinical Performance of Stabilization Splints Produced With a 3D Printer in the Treatment of Bruxism and Temporomandibular Disorders

This will see if 3D-printed night guards work as well as conventional acrylic night guards for adults who grind or clench their teeth, focusing on comfort and how much the splints wear over three months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 25 Years
• Sex: All
• Sponsor: Baskent University (other)
• Locations: 1 site (Ankara)
• Trial ID: NCT07433725 on ClinicalTrials.gov

What this trial studies

This randomized clinical trial will enroll 44 adults with bruxism and randomly assign them to receive either a custom 3D-printed photopolymer occlusal splint (Voco V-Print) or a conventionally fabricated acrylic occlusal splint. Participants will wear their splint during sleep for approximately three months and follow standardized use and care instructions. Patient-reported satisfaction and oral health–related quality of life will be measured with an OHIP-derived questionnaire at the 3-month follow-up, while splint wear will be quantified by 3D scanning and volumetric superimposition. The comparison is designed to determine whether digital 3D-printed splints provide comparable patient-centered outcomes and clinical durability to conventional acrylic splints.

Who should consider this trial

Good fit: Adults (≥18 years) with clinically diagnosed sleep or awake bruxism who need an occlusal splint and can wear it nightly and attend follow-up visits are ideal candidates.

Not a fit: Patients with severe active temporomandibular disorder, extensive untreated dental disease, ongoing orthodontic treatment, recent splint use within six months, or systemic/neurologic conditions or medications that significantly affect bruxism may not benefit or be eligible.

Why it matters

Potential benefit: If successful, 3D-printed splints could offer patients similar comfort and durability while enabling faster digital fabrication and more consistent fits.

How similar studies have performed: Prior small studies and case series have reported promising results for 3D-printed occlusal devices, but high-quality randomized comparisons against conventional acrylic splints remain limited.

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).

Where this trial is running

Ankara

• Başkent University, Faculty of Dentistry — Ankara, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Hale Arıkan Kalaycı, Assistant Professor

Conditions: Bruxism, Sleep, occlusal splint