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NCT01473537 Clinical Trial

Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

Dental Caries Clinical Trial

— Fluor-Ca  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01473537
Other study ID # DDM 2011/1
Secondary ID 2011-001885-16
Status Completed
Phase Phase 1
First received November 14, 2011
Last updated September 21, 2012
Start date October 2011
Est. completion date September 2012

Study information
Verified date September 2012
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencySweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date September 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• calcium lactate solution
Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo

Locations
Country Name City State
Sweden Karolinska Institutet, Dept Dental Medicine Huddinge

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fluoride concentration in resting saliva 12 hours after rinse No
Secondary Discomfort by calcium lactate rinse 12 hours after rinse No
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