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

University of Michigan

Status and phase: Completed; Early Phase 1

Conditions: Dental Caries

Treatments: Drug: Calcium citrate supplement and fluoride mouthwash; Drug: Inactive supplement and fluoride mouthwash; Drug: Inactive supplement; Drug: Calcium citrate supplement; Drug: Calcium carbonate supplement and fluoride mouthwash; Drug: Calcium carbonate supplement; Drug: Tricalcium phosphate supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04620252

HUM00176242

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Reported good general health
• Reported good oral health
• Having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth
• Having normal salivary flow rate according to direct flow rate determination methods
• Agreement to adhere to the study protocol

Exclusion criteria

• Unable to understand and/or follow study instructions
• Hyposalivation
• Active periodontitis, identified by frequent bleeding of the gums
• Oral pain
• In need of urgent dental care

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Chewing calcium supplements

Experimental group

Description:

Participants were given one of 4 different treatments to chew: a negative control group and 3 calcium supplements with different calcium compositions. Participants were randomized to determine the sequence of exposure to the different treatments.

Treatment:

Drug: Tricalcium phosphate supplement

Drug: Inactive supplement

Drug: Calcium citrate supplement

Drug: Calcium carbonate supplement

Fluoride rinse

Experimental group

Description:

Participants rinsed with an over the counter sodium fluoride rinse for 1 min, after having chewed a candy (negative control), a calcium calcium carbonate or a calcium citrate supplement.

Treatment:

Drug: Calcium carbonate supplement and fluoride mouthwash

Drug: Inactive supplement and fluoride mouthwash

Drug: Calcium citrate supplement and fluoride mouthwash