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Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

NCT ID: NCT01473537

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries

Keywords

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dental caries/prevention and control oral health cariostatic agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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calcium lactate solution 75 mM

Group Type ACTIVE_COMPARATOR

calcium lactate solution

Intervention Type DRUG

Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo

calcium lactate solution 150 mM

Group Type ACTIVE_COMPARATOR

calcium lactate solution

Intervention Type DRUG

Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo

placebo

Group Type PLACEBO_COMPARATOR

calcium lactate solution

Intervention Type DRUG

Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo

Interventions

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calcium lactate solution

Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Gunilla Sandborgh Englund

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunilla Sandborgh-Englund, Prof, DDS

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet, Dept Dental Medicine

Huddinge, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2011-001885-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DDM 2011/1

Identifier Type: -

Identifier Source: org_study_id