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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620252
• Other study ID #: HUM00176242
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Inactive supplement
Chewable candy (negative control), chewed for 30 seconds.
• Tricalcium phosphate supplement
Chewable tricalcium phosphate supplement, chewed for 30 seconds.
• Calcium carbonate supplement
Chewable calcium carbonate supplement, chewed for 30 seconds.
• Calcium citrate supplement
Chewable calcium citrate supplement, chewed for 30 seconds.
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	School of Dentistry, University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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