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Manufacturing and Design Variants of Custom-Made Sports Mouthguards: Digital Measurements and Subjective Evaluation

Manufacturing and Design Variants of Custom-Made Sports Mouthguards: Digital Measurements and Subjective Evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036682
Enrollment
40
Registered
2025-04-16
Start date
2025-04-22
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

Sportmouthguards for prevention of dentoalveolar trauma

Interventions

Group 1: First, sports mouthguard type A (conventionally laminated from three individual sheets) for 4 weeks, Washout (1 week), then sports mouthguard type B (pre-laminated three-layer sheet) for 4 we

Sponsors

Poliklinik für Zahnärztliche Prothetik, Universitätsklinikum Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 39 Years

Inclusion criteria

Inclusion criteria: - Informed consent after appropriate verbal and written information - Conservatively and adequately restored dentition without existing gaps - Voluntary participation - Regular engagement in physical activity for at least 2 hours per week

Exclusion criteria

Exclusion criteria: - Participants with Class III occlusion - Fixed orthodontic appliances - Active carious lesions or other invasive treatment needs (e.g., dental restorations, root canal treatments) - Tooth mobility - Abnormal findings in TMD (temporomandibular dysfunction) screening - General medical conditions or physical limitations that preclude physical activity - General medical conditions that interfere with dental treatment - Allergies or intolerances to the materials used - Lack of compliance

Design outcomes

Primary

MeasureTime frame
Layer thickness of the sports mouthguard in mm (after production of the mouthguard)

Secondary

MeasureTime frame
Subjective evaluation of the sports mouthguard (visual analogue scales) initial, after 1 and after 4 weeks

Countries

Germany

Contacts

Public ContactCordula Leonie Merle

Poliklinik für Zahnärztliche Prothetik, Universitätsklinikum Regensburg

cordula.merle@ukr.de094194411910

Outcome results

None listed

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