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Safety, Usability, acceptance, and operative readiness for osmotic agent release from an intraorally cartridge - applied to healthy adults.

Safety, Usability, acceptance, and operative readiness for osmotic agent release from an intraorally cartridge - applied to healthy adults. - OPTIMED-1

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00008914
Enrollment
10
Registered
2015-09-11
Start date
2015-09-18
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

Healthy participants

Interventions

Group 1: Intra-oral appliance and cartridge, filled with 285mg Vitamin C To perform such a clinical trial, the dental bite guard with the cartridge must be retained for 8 to 10 hours within the oral c

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Safety of the device: not more than 10% adverse events within the cohort.

Secondary

MeasureTime frame
functioning of the device: at least 60% release of Vitamin C after 8 hours of intraoral service. usability of the device: no report of habitual problems, which led to a intraoral service time below 6 hours within one day

Countries

Germany

Contacts

Public ContactFabian Huettig

Poliklinik für Zahnärztliche Prothetik mit Propädeutik am Zentrum Zahn-, Mund- und Kieferheilkunde des Universitätsklinikums Tübingen

fabian.huettig@med.uni-tuebingen.de070712986183

Outcome results

None listed

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