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Pilot study comparing different ways of wearing splints for guard awake bruxism

Pilot study comparing different ways of wearing splints for guard awake bruxism

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034881
Enrollment
30
Registered
2024-08-14
Start date
2024-09-04
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

F45.8

Interventions

Group 1: Insertion of a splint for awake bruxism Arm 1: Wearing the splint at night Group 2: Arm 2: Wearing the splint at night and 6 hours during the day

Sponsors

Universitätsklinikum Bonn- ZZMK- Zahnärztliche Prothetik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: probable awake bruxism

Exclusion criteria

Exclusion criteria: lack of patient consent, secondary bruxism, suspected diagnosis of arthropathy, chronic pain GCPS >2, contraindication MRI, patients with dementia or other cognitive impairments who are unable to consent to the study, patients who do not consent to participate in the study for other reasons

Design outcomes

Primary

MeasureTime frame
Assessment of awake bruxism - Subjective before therapy, after 4 weeks and 3 months: - Questionnaire (VAS) for the assessment of awake bruxism - Objective before therapy, after 3 months: - Arrow angle registration - Abrasion facets on the splint (scan of the splint surface) - Clinical functional status and manual structural analysis - MRI if indicated and assessment before therapy, after 3 months: - Position of the condyle in the joint fossa - Change in the volume of the m. pterygoideus lat. - Position of the articular disc in the joint fossa

Secondary

MeasureTime frame
Questionnaires before and after 3 months: - Chron. Pain (GCPS, grade chronic pain scale) - BSI 18 (Brief Symptom Inventory) - SCI (Stress and Coping Inventory)

Countries

Germany

Contacts

Public ContactSabine Linsen

Universitätsklinikum Bonn- ZZMK- Zahnärztliche Prothetik

sabine.linsen@ukbonn.de+4922828722436

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026