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Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01473537
Acronym
Fluor-Ca
Enrollment
9
Registered
2011-11-17
Start date
2011-10-31
Completion date
2012-09-30
Last updated
2012-09-25

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

Conditions

Dental Caries

Keywords

dental caries/prevention and control, oral health, cariostatic agents

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.

Interventions

DRUGcalcium lactate solution

Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Fluoride concentration in resting saliva12 hours after rinse

Secondary

MeasureTime frame
Discomfort by calcium lactate rinse12 hours after rinse

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026