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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gunilla Sandborgh Englund, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01473537
First received: November 14, 2011
Last updated: September 21, 2012
Last verified: September 2012
History of Changes

November 14, 2011
September 21, 2012
October 2011
March 2012   (final data collection date for primary outcome measure)
Fluoride concentration in resting saliva [ Time Frame: 12 hours after rinse ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01473537
DDM 2011/1, 2011-001885-16
Yes
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