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

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ClinicalTrials.gov Identifier: NCT04620252
Recruitment Status : Completed
First Posted : November 6, 2020
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Livia Tenuta, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Caries 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 Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Calcium concentration in saliva at baseline [ Time Frame: 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.

  2. Calcium concentration in the mixture of saliva and chewed calcium supplement [ Time Frame: 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.

  3. Calcium concentration in saliva at 15 seconds [ Time Frame: 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.

  4. Calcium concentration in saliva at 30 seconds [ Time Frame: 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.

  5. Calcium concentration in saliva at 45 seconds [ Time Frame: 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.

  6. Calcium concentration in saliva at 60 seconds [ Time Frame: 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.

  7. Calcium concentration in saliva at 120 seconds [ Time Frame: 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.

  8. Calcium concentration in saliva at 180 seconds [ Time Frame: 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.

  9. Calcium concentration in saliva at 240 seconds [ Time Frame: 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.

  10. Calcium concentration in saliva at 300 seconds [ Time Frame: 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.

  11. Area under the curve of calcium concentration in saliva [ Time Frame: 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).

  12. Fluoride concentration in saliva at baseline [ Time Frame: 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.

  13. Fluoride concentration in saliva at time 0 [ Time Frame: 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.

  14. Fluoride concentration in saliva at 5 min [ Time Frame: 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.

  15. Fluoride concentration in saliva at 15 min [ Time Frame: 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.

  16. Fluoride concentration in saliva at 30 min [ Time Frame: 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.

  17. Fluoride concentration in saliva at 60 min [ Time Frame: 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.

  18. Fluoride concentration in saliva at 120 min [ Time Frame: 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.

  19. Area under the curve of fluoride concentration in saliva [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620252


Locations
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United States, Michigan
School of Dentistry, University of Michigan
Ann Arbor, Michigan, United States, 48109-1078
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Livia M Tenuta, DDS, MS, PhD Associate Professor, University of Michigan
More Information
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Responsible Party: Livia Tenuta, DDS, MS, PhD, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04620252    
Other Study ID Numbers: HUM00176242
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022

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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
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Calcium Carbonate
Citric Acid
Sodium Citrate
Calcium
Fluorides
Calcium-Regulating Hormones and Agents
 Physiological Effects of Drugs
Bone Density Conservation Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Cariostatic Agents
Protective Agents
Antacids
Gastrointestinal Agents