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Completed

NCT Number: NCT04620252

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

School of Dentistry, University of Michigan

Ann Arbor, Michigan, 48109-1078, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inactive supplement

Drug

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

Tricalcium phosphate supplement

Drug

Chewable tricalcium phosphate supplement, chewed for 30 seconds.

Calcium carbonate supplement

Drug

Chewable calcium carbonate supplement, chewed for 30 seconds.

Calcium citrate supplement

Drug

Chewable calcium citrate supplement, chewed for 30 seconds.

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).

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).

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).

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 6, 2020
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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