Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium (Fluor-Ca)

Karolinska Institute

Status and phase: Completed; Phase 1

Conditions: Dental Caries

Treatments: Drug: calcium lactate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01473537

2011-001885-16 (EudraCT Number)

DDM 2011/1

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• 10 natural teeth or more
• willing to refrain from use of fluoride containing products
• signed informed consent

Exclusion criteria

• less than 10 natural teeth
• reduced cognitive skills
• does not speak and/or understand Swedish
• ongoing oral or systemic infections
• pregnancy
• breast feeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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9 participants in 3 patient groups, including a placebo group

calcium lactate solution 75 mM

Active Comparator group

Treatment:

Drug: calcium lactate solution

calcium lactate solution 150 mM

Active Comparator group

Treatment:

Drug: calcium lactate solution

placebo

Placebo Comparator group

Treatment:

Drug: calcium lactate solution