Determination of Drugs in Dental Material
- Conditions
- healty subjects and Patients with regular ongoing medication e.g. analgesics
- Registration Number
- DRKS00011148
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 62
Health subjects:
-Age: 18-50
-healthy subject as evaluated by the investigator
-women: at least one established method of contraception
-sound or restored dentiton
-given written informed consent
Subjects under medication:
-Age: 18-50
-classified as of reduced but stable general heath, assessed by the responsible specialist for addiction medicine and by the investigator
-women: at least one established method of contraception
-sound or restored dentiton
-given written informed consent
-constant consumption of an individual amount of methadone or pain drug prescribed by the responsible specialist (for addiction medicine) (other drugs, reported by the responsible specialist for addiction medicine and the subject will be logged in the patients file)
-women: pregnant or breast feeding
-withdrawal of informed consent
-known allergies against used dental materials
-dention not sound or current dental treatment except emergency treatment
-intake of drugs that interfere with the detection of the test substances
-participation in another clinical trail within the last 30 days
-intake of antibiotics within the last 2 months
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantification of drugs (model substances: (Amphetamine, Methamphetamine, MDMA, MDA, MDE, Cocaine, Benzoylecgonine, Morphine, Codeine, Monoacetylmorphine) in dentin and enamel samples on intraoral sample holders by LC-MS/MS after a single simulated consumption or after 5 days, 2 and 4 weeks of treatment of the samples with a drug solution.<br>Quantification of drugs in dentin and enamel samples on intraoral sample holders or prostheses by LC-MS/MS after regular drug intake
- Secondary Outcome Measures
Name Time Method Determination of drugs (=model substances) in dentin and enamel samples on intraoral sample holders by LC-MS/MS after a single simulated consumption or after 5 days, 2 and 4 weeks of treatment of the samples with a drug solution.<br>Determination of drugs in dentin and enamel samples on intraoral sample holders by LC-MS/MS after regular drug intake