Prospective clinical trial evaluating 3D-printed occlusal splints
Not Applicable
Recruiting
- Conditions
- K07.6Temporomandibular joint disorders
- Registration Number
- DRKS00033904
- Lead Sponsor
- Klinik für Zahnärztliche Prothetik, Universitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
known allergy to materials used in the study, drug/alcohol abuse
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Therapeutic efficiency and technical outcome<br>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). <br>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.