Fluoride in saliva during and after use of high-fluoride toothpaste

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000213-33-DK

Enrollment

Registered

2020-02-26

Start date

2020-04-21

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable. A physiological phenomena is explored. MedDRA version: 21.0 Level: LLT Classification code 10053349 Term: Pharmacokinetic study System Organ Class: 100000004848

Interventions

Trade Name: Duraphat 5mg/g tandpasta Pharmaceutical Form: Toothpaste Pharmaceutical form of the placebo: Toothpaste Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Denmark

Contacts

Public ContactLine Staun Larsen

Department of Dentistry and Oral Health

line.staun@dent.au.dk+4587168479

Outcome results

None listed

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