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

Primary Purpose

Dental Caries

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Inactive supplement
Tricalcium phosphate supplement
Calcium carbonate supplement
Calcium citrate supplement
Inactive supplement and fluoride mouthwash
Calcium carbonate supplement and fluoride mouthwash
Calcium citrate supplement and fluoride mouthwash
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dentistry, University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chewing calcium supplements

Fluoride rinse

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
November 5, 2020
Last Updated
May 2, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04620252
Brief Title
Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride
Official Title
Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chewing calcium supplements
Arm Type
Experimental
Arm Description
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.
Arm Title
Fluoride rinse
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Inactive supplement
Intervention Description
Chewable candy (negative control), chewed for 30 seconds.
Intervention Type
Drug
Intervention Name(s)
Tricalcium phosphate supplement
Intervention Description
Chewable tricalcium phosphate supplement, chewed for 30 seconds.
Intervention Type
Drug
Intervention Name(s)
Calcium carbonate supplement
Intervention Description
Chewable calcium carbonate supplement, chewed for 30 seconds.
Intervention Type
Drug
Intervention Name(s)
Calcium citrate supplement
Intervention Description
Chewable calcium citrate supplement, chewed for 30 seconds.
Intervention Type
Drug
Intervention Name(s)
Inactive supplement and fluoride mouthwash
Intervention Description
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
Intervention Name(s)
Calcium carbonate supplement and fluoride mouthwash
Intervention Description
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
Intervention Name(s)
Calcium citrate supplement and fluoride mouthwash
Intervention Description
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).
Primary Outcome Measure Information:
Title
Calcium concentration in saliva at baseline
Description
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.
Time Frame
Baseline
Title
Calcium concentration in the mixture of saliva and chewed calcium supplement
Description
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.
Time Frame
Immediately after the 30-second chewing of calcium supplement
Title
Calcium concentration in saliva at 15 seconds
Description
Saliva collected as one spit, 15 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Time Frame
15 seconds after chewing calcium supplement
Title
Calcium concentration in saliva at 30 seconds
Description
Saliva collected as one spit, 30 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Time Frame
30 seconds after chewing calcium supplement
Title
Calcium concentration in saliva at 45 seconds
Description
Saliva collected as one spit, 45 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Time Frame
45 seconds after chewing calcium supplement
Title
Calcium concentration in saliva at 60 seconds
Description
Saliva collected as one spit, 60 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Time Frame
60 seconds after chewing calcium supplement
Title
Calcium concentration in saliva at 120 seconds
Description
Saliva collected as one spit, 120 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Time Frame
120 seconds after chewing calcium supplement
Title
Calcium concentration in saliva at 180 seconds
Description
Saliva collected as one spit, 180 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Time Frame
180 seconds after chewing calcium supplement
Title
Calcium concentration in saliva at 240 seconds
Description
Saliva collected as one spit, 240 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Time Frame
240 seconds after chewing calcium supplement
Title
Calcium concentration in saliva at 300 seconds
Description
Saliva collected as one spit, 300 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Time Frame
300 seconds after chewing calcium supplement
Title
Area under the curve of calcium concentration in saliva
Description
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).
Time Frame
Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements
Title
Fluoride concentration in saliva at baseline
Description
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.
Time Frame
Baseline
Title
Fluoride concentration in saliva at time 0
Description
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.
Time Frame
0 minutes after chewing supplement/mouthwashing
Title
Fluoride concentration in saliva at 5 min
Description
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.
Time Frame
5 minutes after chewing supplement/mouthwashing
Title
Fluoride concentration in saliva at 15 min
Description
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.
Time Frame
15 minutes after chewing supplement/mouthwashing
Title
Fluoride concentration in saliva at 30 min
Description
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.
Time Frame
30 minutes after chewing supplement/mouthwashing
Title
Fluoride concentration in saliva at 60 min
Description
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.
Time Frame
60 minutes after chewing supplement/mouthwashing
Title
Fluoride concentration in saliva at 120 min
Description
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.
Time Frame
120 minutes after chewing supplement/mouthwashing
Title
Area under the curve of fluoride concentration in saliva
Description
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).
Time Frame
Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia M Tenuta, DDS, MS, PhD
Organizational Affiliation
Associate Professor, University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-1078
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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