Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium
Fluor-Ca
A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride
2 other identifiers
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 25, 2012
September 1, 2012
5 months
November 14, 2011
September 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fluoride concentration in resting saliva
12 hours after rinse
Secondary Outcomes (1)
Discomfort by calcium lactate rinse
12 hours after rinse
Study Arms (3)
calcium lactate solution 75 mM
ACTIVE COMPARATORcalcium lactate solution 150 mM
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo
Eligibility Criteria
You may qualify if:
- years or older
- natural teeth or more
- willing to refrain from use of fluoride containing products
- signed informed consent
You may not qualify if:
- less than 10 natural teeth
- reduced cognitive skills
- does not speak and/or understand Swedish
- ongoing oral or systemic infections
- pregnancy
- breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska Institutet, Dept Dental Medicine
Huddinge, SE14104, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunilla Sandborgh-Englund, Prof, DDS
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 14, 2011
First Posted
November 17, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
September 1, 2012
Last Updated
September 25, 2012
Record last verified: 2012-09