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Prospective clinical trial evaluating 3D-printed occlusal splints

Prospective clinical trial evaluating 3D-printed occlusal splints

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033904
Enrollment
40
Registered
2024-03-15
Start date
2024-03-14
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K07.6

Interventions

Group 1: bruxism After an initial examination and digital impression, the patients receive an occlusal splint ("type Michigan") in the upper jaw. 2 weeks and 3 months after insertion of the first spl

Sponsors

Klinik für Zahnärztliche Prothetik, Universitätsklinikum Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients are in need of a "Michigan splint" to be worn at night in the upper jaw. The patient's general state of health must permit dental treatment. Bruxism cohort: Bruxism screening index of the German Society of Craniomandibular Function and Disorders must indicate probable bruxism. Myoarthropathy cohort: Myalgia, myofascial pain and/or arthralgia of the jaw muscles/joints is present. The GCPS 2.0 is less than grade 2.

Exclusion criteria

Exclusion criteria: known allergy to materials used in the study, drug/alcohol abuse

Design outcomes

Primary

MeasureTime frame
Patient satisfaction and quality of life, evaluation with an established questionnaire on quality of life (OHIP-G14) and one question each on wearing comfort and retention of the occlusal splint (assessment of wearing comfort and retention with a VAS scale of 1-10), the questionnaires are completed as part of the initial assessment, at the check-up 2 weeks after insertion of the splint and after the 3-month wearing period of the splint

Secondary

MeasureTime frame
Therapeutic efficiency and technical outcome Assessment of treatment efficacy in the bruxism cohort via the extent of abrasion of the opposing dentition (measured in µm3 by superimposing intraoral scans) and in the myoarthropathy cohort via pain reduction (evaluated using the clinically established Graded Chronic Pain Status (GCPS 2.0) and the number of painful points on examination according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). The following parameters of the technical result are analysed: Fit at insertion (superimposition of scans before and after fitting the splint), wear of the occlusal splints (superimposition of scans see above) and integrity of the occlusal splints (no fracture of the occlusal splint) at follow-up appointments. The assessment is carried out when the splint is fitted and at check-ups after 2 weeks and 3 months.

Countries

Germany

Contacts

Public ContactKerstin Rabel

Klinik für Zahnärztliche Prothetik, Universitätsklinikum Freiburg

kerstin.rabel@uniklinik-freiburg.de004976127047680

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026