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

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
calcium lactate solution
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring dental caries/prevention and control, oral health, cariostatic agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karolinska Institutet, Dept Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

calcium lactate solution 75 mM

calcium lactate solution 150 mM

placebo

Arm Description

Outcomes

Primary Outcome Measures

Fluoride concentration in resting saliva

Secondary Outcome Measures

Discomfort by calcium lactate rinse

Full Information

First Posted
November 14, 2011
Last Updated
September 21, 2012
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01473537
Brief Title
Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium
Acronym
Fluor-Ca
Official Title
A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries/prevention and control, oral health, cariostatic agents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
calcium lactate solution 75 mM
Arm Type
Active Comparator
Arm Title
calcium lactate solution 150 mM
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
calcium lactate solution
Intervention Description
Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo
Primary Outcome Measure Information:
Title
Fluoride concentration in resting saliva
Time Frame
12 hours after rinse
Secondary Outcome Measure Information:
Title
Discomfort by calcium lactate rinse
Time Frame
12 hours after rinse

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunilla Sandborgh-Englund, Prof, DDS
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Dept Dental Medicine
City
Huddinge
ZIP/Postal Code
SE14104
Country
Sweden

12. IPD Sharing Statement

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Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

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