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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
  Purpose

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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Gunilla Sandborgh Englund, Karolinska Institutet:

Primary Outcome Measures:
  • Fluoride concentration in resting saliva [ Time Frame: 12 hours after rinse ]

Secondary Outcome Measures:
  • Discomfort by calcium lactate rinse [ Time Frame: 12 hours after rinse ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473537


Locations
Sweden
Karolinska Institutet, Dept Dental Medicine
Huddinge, Sweden, SE14104
Sponsors and Collaborators
Karolinska Institutet
Investigators
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 ( EudraCT Number )
First Submitted: November 14, 2011
First Posted: November 17, 2011
Last Update Posted: September 25, 2012
Last Verified: September 2012

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

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