Fluoride in saliva during and after use of high-fluoride toothpaste
Phase 1
- Conditions
- Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]ot applicable. A physiological phenomena is explored.MedDRA version: 21.0Level: LLTClassification code 10053349Term: Pharmacokinetic studySystem Organ Class: 100000004848
- Registration Number
- EUCTR2020-000213-33-DK
- Lead Sponsor
- Department of Dentistry and Oral Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Adult (>18 years old), 'dentate' individuals (>20 teeth).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Hyposalivation (unstimulated saliva flow >1ml/5 minutes; drooling method), allergy to constituents in the toothpastes (cf. the product summary for Duraphat), pregnancy and nursing.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To explore the supplementary effect, many hours after brushing, on the fluoride concentration in saliva both during regular use of and after terminated use of high-fluoride toothpaste (Duraphat 5mg/g toothpaste).;Secondary Objective: Not applicable.;Primary end point(s): The fluoride concentration in saliva.;Timepoint(s) of evaluation of this end point: After 1, 2 and 3 weeks use of Duraphat 5mg/g tothpaste, and 1 and 2 weeks after terminated use of the toothpaste.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.