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

NCT04620252 | Completed Early Phase 1

• 1 other identifier: HUM00176242
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

Chewing calcium supplements

EXPERIMENTAL

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; Drug: Tricalcium phosphate supplement; Drug: Calcium carbonate supplement; Drug: Calcium citrate supplement

Fluoride rinse

EXPERIMENTAL

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; Drug: Calcium carbonate supplement and fluoride mouthwash; Drug: Calcium citrate supplement and fluoride mouthwash

Interventions

Inactive supplement DRUG

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

Chewing calcium supplements

Tricalcium phosphate supplement DRUG

Chewable tricalcium phosphate supplement, chewed for 30 seconds.

Chewing calcium supplements

Calcium carbonate supplement DRUG

Chewable calcium carbonate supplement, chewed for 30 seconds.

Chewing calcium supplements

Calcium citrate supplement DRUG

Chewable calcium citrate supplement, chewed for 30 seconds.

Chewing calcium supplements

Inactive supplement and fluoride mouthwash 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).

Fluoride rinse

Calcium carbonate supplement and fluoride mouthwash 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).

Fluoride rinse

Calcium citrate supplement and fluoride mouthwash 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).

Fluoride rinse

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

School of Dentistry, University of Michigan

Ann Arbor, Michigan, 48109-1078, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Livia M Tenuta, DDS, MS, PhD

  Associate Professor, University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MS, PhD, Associate Professor

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 6, 2020
• Study Start: February 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

US (1)