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

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

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.

Condition Intervention Phase
Dental Caries
Drug: calcium lactate solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride

Resource links provided by NLM:

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Fluoride concentration in resting saliva [ Time Frame: 12 hours after rinse ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Discomfort by calcium lactate rinse [ Time Frame: 12 hours after rinse ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: calcium lactate solution 75 mM Drug: calcium lactate solution
Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo
Active Comparator: calcium lactate solution 150 mM Drug: calcium lactate solution
Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo
Placebo Comparator: placebo Drug: calcium lactate solution
Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01473537

Karolinska Institutet, Dept Dental Medicine
Huddinge, Sweden, SE14104
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Gunilla Sandborgh-Englund, Prof, DDS Karolinska Institutet
  More Information

Responsible Party: Gunilla Sandborgh Englund, professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01473537     History of Changes
Other Study ID Numbers: DDM 2011/1  2011-001885-16 
Study First Received: November 14, 2011
Last Updated: September 21, 2012
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
dental caries/prevention and control
oral health
cariostatic agents

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Calcium, Dietary
Pharmaceutical Solutions
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016