NCT04620252

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

Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2020-11-06
• Last updated: 2022-05-09

Locations

1 site across 1 country: United States