Safety, Usability, acceptance, and operative readiness for osmotic agent release from an intraorally cartridge - applied to healthy adults.
Phase 2
- Conditions
- Healthy participants
- Registration Number
- DRKS00008914
- Lead Sponsor
- niversitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
capacity to contract and signed informed consent, stable conditions of the dentition at least in one jaw, no acute dental treatment need (no caries, no extractions, no tooth loosening of grade 2 or higher at two or more teeth, no periodontits acc. PSI Code <=2) no inflammation or irritation of oral soft tissues esp. at the planum buccale
Exclusion Criteria
addictions (excl. nicotine), ongoing dental or orthodontic treatment(s), problems with swallowing, removable partial dentures in both jaws, no availablitiy or travelling during the 3 days of study phase, mouth opening below 25mm distance between the incisal edges.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of the device: not more than 10% adverse events within the cohort.
- Secondary Outcome Measures
Name Time Method functioning of the device: at least 60% release of Vitamin C after 8 hours of intraoral service. <br>usability of the device: no report of habitual problems, which led to a intraoral service time below 6 hours within one day