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Completed

NCT Number: NCT01473537

Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Karolinska Institutet, Dept Dental Medicine

Huddinge, SE14104, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calcium lactate solution

Drug

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

Primary outcomes

  1. Fluoride concentration in resting saliva

    Time frame: 12 hours after rinse

Secondary outcomes

  1. Discomfort by calcium lactate rinse

    Time frame: 12 hours after rinse

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Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride

Acronym: Fluor-Ca

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 17, 2011
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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