Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium
- Registration Number
- NCT01473537
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.
Procedure: Rinses are performed in the evening. The rinse combinations are given in a random order, and the subjects are unaware of the sequence. At least 3 days separates the use of each rinse. Dosage: 20 mL and 1 minute rinse with each solution.
Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by expectoration.
Analysis: The fluoride concentration in saliva samples are analysed Statistics and data handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated measures design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 18 years or older
- 10 natural teeth or more
- willing to refrain from use of fluoride containing products
- signed informed consent
- less than 10 natural teeth
- reduced cognitive skills
- does not speak and/or understand Swedish
- ongoing oral or systemic infections
- pregnancy
- breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description calcium lactate solution 75 mM calcium lactate solution - calcium lactate solution 150 mM calcium lactate solution - placebo calcium lactate solution -
- Primary Outcome Measures
Name Time Method Fluoride concentration in resting saliva 12 hours after rinse
- Secondary Outcome Measures
Name Time Method Discomfort by calcium lactate rinse 12 hours after rinse
Trial Locations
- Locations (1)
Karolinska Institutet, Dept Dental Medicine
🇸🇪Huddinge, Sweden