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

Early Phase 1

Completed

• Conditions: Dental Caries
• Interventions: Drug: Inactive supplement; Drug: Inactive supplement and fluoride mouthwash; Drug: Calcium carbonate supplement and fluoride mouthwash; Drug: Tricalcium phosphate supplement; Drug: Calcium carbonate supplement; Drug: Calcium citrate supplement and fluoride mouthwash; Drug: Calcium citrate supplement

• Registration Number: NCT04620252
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-06
• Study Start: 2021-02-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chewing calcium supplements	Calcium carbonate supplement	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.
Chewing calcium supplements	Inactive supplement	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.
Chewing calcium supplements	Calcium citrate supplement	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.
Fluoride rinse	Inactive supplement and fluoride mouthwash	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.
Fluoride rinse	Calcium carbonate supplement and fluoride mouthwash	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.
Fluoride rinse	Calcium citrate supplement and fluoride mouthwash	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.
Chewing calcium supplements	Tricalcium phosphate supplement	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.

Primary Outcome Measures

Name	Time	Method
Calcium concentration in saliva at 45 seconds	45 seconds after chewing calcium supplement	Saliva collected as one spit, 45 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at baseline	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.
Calcium concentration in the mixture of saliva and chewed calcium supplement	Immediately after the 30-second chewing of 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.
Calcium concentration in saliva at 15 seconds	15 seconds after chewing calcium supplement	Saliva collected as one spit, 15 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 30 seconds	30 seconds after chewing calcium supplement	Saliva collected as one spit, 30 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 60 seconds	60 seconds after chewing calcium supplement	Saliva collected as one spit, 60 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 120 seconds	120 seconds after chewing calcium supplement	Saliva collected as one spit, 120 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 180 seconds	180 seconds after chewing calcium supplement	Saliva collected as one spit, 180 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 240 seconds	240 seconds after chewing calcium supplement	Saliva collected as one spit, 240 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 300 seconds	300 seconds after chewing calcium supplement	Saliva collected as one spit, 300 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Area under the curve of calcium concentration in saliva	Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements	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).
Fluoride concentration in saliva at baseline	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.
Fluoride concentration in saliva at 5 min	5 minutes after chewing supplement/mouthwashing	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.
Fluoride concentration in saliva at time 0	0 minutes after chewing supplement/mouthwashing	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.
Fluoride concentration in saliva at 30 min	30 minutes after chewing supplement/mouthwashing	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.
Fluoride concentration in saliva at 15 min	15 minutes after chewing supplement/mouthwashing	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.
Fluoride concentration in saliva at 60 min	60 minutes after chewing supplement/mouthwashing	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.
Fluoride concentration in saliva at 120 min	120 minutes after chewing supplement/mouthwashing	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.
Area under the curve of fluoride concentration in saliva	Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing	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).

Trial Locations

Locations (1)

School of Dentistry, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States