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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Inactive supplement; Drug: Tricalcium phosphate supplement; Drug: Calcium carbonate supplement; Drug: Calcium citrate supplement; Drug: Inactive supplement and fluoride mouthwash; Drug: Calcium carbonate supplement and fluoride mouthwash; Drug: Calcium citrate supplement and fluoride mouthwash

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1078
      • School of Dentistry, University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcium concentration in saliva at baseline	Saliva collected as one spit, immediately before chewing one of the calcium supplements to be tested in Arm 1. Calcium concentration determined using a colorimetric method.	Baseline
Calcium concentration in the mixture of saliva and chewed calcium supplement	Saliva and remnants of the chewed calcium supplement collected at the end of the chewing period (30 seconds) in Arm 1. Calcium concentration determined using a colorimetric method.	Immediately after the 30-second chewing of calcium supplement
Calcium concentration in saliva at 15 seconds	Saliva collected as one spit, 15 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.	15 seconds after chewing calcium supplement
Calcium concentration in saliva at 30 seconds	Saliva collected as one spit, 30 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.	30 seconds after chewing calcium supplement
Calcium concentration in saliva at 45 seconds	Saliva collected as one spit, 45 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.	45 seconds after chewing calcium supplement
Calcium concentration in saliva at 60 seconds	Saliva collected as one spit, 60 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.	60 seconds after chewing calcium supplement
Calcium concentration in saliva at 120 seconds	Saliva collected as one spit, 120 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.	120 seconds after chewing calcium supplement
Calcium concentration in saliva at 180 seconds	Saliva collected as one spit, 180 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.	180 seconds after chewing calcium supplement
Calcium concentration in saliva at 240 seconds	Saliva collected as one spit, 240 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.	240 seconds after chewing calcium supplement
Calcium concentration in saliva at 300 seconds	Saliva collected as one spit, 300 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.	300 seconds after chewing calcium supplement
Area under the curve of calcium concentration in saliva	Calcium concentration in saliva collected at baseline (before chewing the supplements), and 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing the supplements in Arm 1 expressed as the area under the curve of calcium concentration in saliva as a function of time (milimolar x min).	Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements
Fluoride concentration in saliva at baseline	Saliva will be collected for 2 min, immediately before chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode.	Baseline
Fluoride concentration in saliva at time 0	Saliva and remnants of the fluoride mouth rinse collected at the end of the rinsing period (1 minute) in Arm 2. Fluoride concentration determined using an ion-specific electrode.	0 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 5 min	Saliva will be collected for 2 min, 5 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode.	5 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 15 min	Saliva collected for 2 min, 15 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.	15 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 30 min	Saliva collected for 2 min, 30 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.	30 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 60 min	Saliva collected for 2 min, 60 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.	60 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 120 min	Saliva collected for 2 min, 120 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.	120 minutes after chewing supplement/mouthwashing
Area under the curve of fluoride concentration in saliva	Fluoride concentration in saliva collected at baseline (before treatments), and 0, 5, 15, 30, 60 and 120 minutes after chewing the supplements and/or rinsing the fluoride mouthrinse in Arm 2 expressed as the area under the curve of fluoride concentration in saliva as a function of time (micromolar x min).	Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Livia M Tenuta, DDS, MS, PhD, Associate Professor, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Protective Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Anticoagulants; Cariostatic Agents; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Antacids; Calcium; Fluorides; Calcium, Dietary; Calcium Carbonate; Citric Acid; Sodium Citrate
• Other Study ID Numbers: HUM00176242

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No