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

Summary

The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of fluoride. The hypothesis of this study is that the same can be achieved by chewing a calcium supplement prior to a fluoride rinse. The first goal is to determine if chewing these calcium supplements will increase calcium concentration in the oral fluids above baseline levels. Secondly, the calcium supplement with the highest calcium release will be tested before a fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared with the fluoride rinse alone. In both parts, healthy volunteers will participate and saliva will be collected to assess calcium and fluoride concentration.

Conditions

• Dental Caries

Interventions

DRUG

Inactive supplement

Chewable candy (negative control), chewed for 30 seconds.

DRUG

Tricalcium phosphate supplement

Chewable tricalcium phosphate supplement, chewed for 30 seconds.

DRUG

Calcium carbonate supplement

Chewable calcium carbonate supplement, chewed for 30 seconds.

DRUG

Calcium citrate supplement

Chewable calcium citrate supplement, chewed for 30 seconds.

DRUG

Inactive supplement and fluoride mouthwash

A chewable candy chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).

DRUG

Calcium carbonate supplement and fluoride mouthwash

A calcium carbonate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).

DRUG

Calcium citrate supplement and fluoride mouthwash

A calcium citrate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).

Sponsors & Collaborators

• University of Michigan

  lead OTHER

Principal Investigators

• Livia M Tenuta, DDS, MS, PhD · Associate Professor, University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-01

Primary Completion

2022-03-31

Completion

2022-03-31

Countries

• United States

Study Locations