Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium
Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Caries
Intervention: calcium lactate solution (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s): Gunilla Sandborgh-Englund, Prof, DDS, Principal Investigator, Affiliation: Karolinska Institutet
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.
Clinical Details
Official title: A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Fluoride concentration in resting saliva
Secondary outcome: Discomfort by calcium lactate rinse
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Karolinska Institutet, Dept Dental Medicine, Huddinge SE14104, Sweden
Additional Information
Starting date: October 2011
Last updated: September 21, 2012
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