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

NCT ID: NCT04620252

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Chewing calcium supplements

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.

Group Type: EXPERIMENTAL

Inactive supplement

Intervention Type: DRUG

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

Tricalcium phosphate supplement

Intervention Type: DRUG

Chewable tricalcium phosphate supplement, chewed for 30 seconds.

Calcium carbonate supplement

Intervention Type: DRUG

Chewable calcium carbonate supplement, chewed for 30 seconds.

Calcium citrate supplement

Intervention Type: DRUG

Chewable calcium citrate supplement, chewed for 30 seconds.

Fluoride rinse

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.

Group Type: EXPERIMENTAL

Inactive supplement and fluoride mouthwash

Intervention Type: DRUG

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).

Calcium carbonate supplement and fluoride mouthwash

Intervention Type: DRUG

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).

Calcium citrate supplement and fluoride mouthwash

Intervention Type: DRUG

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).

Interventions

Inactive supplement

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

Intervention Type: DRUG

Tricalcium phosphate supplement

Chewable tricalcium phosphate supplement, chewed for 30 seconds.

Intervention Type: DRUG

Calcium carbonate supplement

Chewable calcium carbonate supplement, chewed for 30 seconds.

Intervention Type: DRUG

Calcium citrate supplement

Chewable calcium citrate supplement, chewed for 30 seconds.

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Livia Tenuta

DDS, MS, PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Livia M Tenuta, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, University of Michigan

Locations

School of Dentistry, University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00176242

Identifier Type: -

Identifier Source: org_study_id