Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride

NCT04620252

Dental Caries

COMPLETED EARLY_PHASE1

Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH

NCT00875212

Dental Caries

COMPLETED PHASE1

Intra Oral Kinetics of Fluoride Containing Dentifrices

NCT02548156

Tooth Erosion

COMPLETED NA

Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients

NCT01768390

Dental Caries

COMPLETED PHASE4

Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

NCT00752089

Dental Erosion

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

calcium lactate solution

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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