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
  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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Calcium, Dietary
Fluorides
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents

ClinicalTrials.gov processed this record on September 22, 2014