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Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses

Sponsor
University of Michigan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05601154
Collaborator
(none)
20
Enrollment
4
Arms
16.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, over the age of 18 years-old, from both genders, with normal oral health conditions and salivary flow rate, no need of urgent dental needs, from the Ann Arbor, MI area. Participants will be recruited from the University of Michigan School of Dentistry, in Ann Arbor, MI. Using a crossover design, twenty participants will be rotating through 4 different combinations of fluoride toothpaste (over-the-counter or prescription concentration) and fluoride mouth rinse (yes or no), in a 2 x 2 factorial design. Treatments to be tested will be as followed: Group #1 will brush with 1,100 ppm F (over-the-counter) toothpaste; Group #2 will brush with 1,100 ppm F (over-the-counter) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse; Group #3 will brush with 5,000 ppm F (prescription) toothpaste; Group #4 will brush with 5,000 ppm F (prescription) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse.

Condition or Disease Intervention/Treatment Phase
  • Drug: Crest Cavity Protection toothpaste
  • Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse
  • Drug: Colgate PreviDent 5000+ toothpaste
  • Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Crest Cavity Protection

Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water

Drug: Crest Cavity Protection toothpaste
Participants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds
Other Names:
  • Over-the-counter fluoride toothpaste followed by water rinse

    		•
    Active Comparator: Crest Cavity Protection followed by Act Mint Fluoride Rinse

    Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm)

    Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse
    Participants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute
    Other Names:
  • Over-the-counter fluoride toothpaste followed by fluoride rinse

    		•
    Active Comparator: Colgate PreviDent 5000+

    Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water

    Drug: Colgate PreviDent 5000+ toothpaste
    Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds
    Other Names:
  • Prescription fluoride toothpaste followed by water rinse

    		•
    Experimental: Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse

    Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm)

    Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse
    Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute
    Other Names:
  • Prescription fluoride toothpaste followed by fluoride rinse

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the curve of fluoride bioavailability in saliva [0 to 60 minutes after the interventions]

      Fluoride concentration in saliva will be measured before (baseline) and up to 60 min after the interventions, and the area under the curve of fluoride concentration versus time will be calculated to estimate bioavailability

    Secondary Outcome Measures

    1. Maximum fluoride concentration in saliva [0 to 60 minutes after the interventions]

      From the area under the curve, the time at which the concentration in saliva is highest will be determined

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Sign informed consent form

    • Participant understands and agrees to comply with the study protocol, and confirms availability for the entire duration of the study

    • 18 years of age or older

    • Good general health

    • Good oral health, with no urgent treatment needs

    • Normal salivary flow rate

    Exclusion Criteria:

    • Fail to understand or to agree to follow the study protocol

    • Reduced salivary flow rate

    • Poor general or oral health conditions

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Livia Tenuta, Associate Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT05601154
    Other Study ID Numbers:
    • HUM00212598
    First Posted:
    Nov 1, 2022
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dental Caries
    Listerine
    Fluorides
    Sodium Fluoride

    Study Results

    No Results Posted as of Jan 25, 2023