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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01473537
First Posted: November 17, 2011
Last Update Posted: September 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gunilla Sandborgh Englund, Karolinska Institutet
November 14, 2011
November 17, 2011
September 25, 2012
October 2011
March 2012   (Final data collection date for primary outcome measure)
Fluoride concentration in resting saliva [ Time Frame: 12 hours after rinse ]
Same as current
Complete list of historical versions of study NCT01473537 on ClinicalTrials.gov Archive Site
Discomfort by calcium lactate rinse [ Time Frame: 12 hours after rinse ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Dental Caries
Drug: calcium lactate solution
Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo
  • Active Comparator: calcium lactate solution 75 mM
    Intervention: Drug: calcium lactate solution
  • Active Comparator: calcium lactate solution 150 mM
    Intervention: Drug: calcium lactate solution
  • Placebo Comparator: placebo
    Intervention: Drug: calcium lactate solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
September 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01473537
DDM 2011/1
2011-001885-16 ( EudraCT Number )
Yes
Not Provided
Not Provided
Gunilla Sandborgh Englund, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Gunilla Sandborgh-Englund, Prof, DDS Karolinska Institutet
Karolinska Institutet
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP