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

Primary Purpose

Dental Caries

Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Crest Cavity Protection toothpaste
Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse
Colgate PreviDent 5000+ toothpaste
Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse
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 - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dentistry, University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

Crest Cavity Protection

Crest Cavity Protection followed by Act Mint Fluoride Rinse

Colgate PreviDent 5000+

Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse

Arm Description

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

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)

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

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)

Outcomes

Primary Outcome Measures

Area under the curve of fluoride bioavailability in saliva
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

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

Full Information

First Posted
October 26, 2022
Last Updated
April 4, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05601154
Brief Title
Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses
Official Title
Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

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
Data Monitoring Committee
No

5. 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.

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
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crest Cavity Protection
Arm Type
Active Comparator
Arm Description
Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water
Arm Title
Crest Cavity Protection followed by Act Mint Fluoride Rinse
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Colgate PreviDent 5000+
Arm Type
Active Comparator
Arm Description
Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water
Arm Title
Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Crest Cavity Protection toothpaste
Other Intervention Name(s)
Over-the-counter fluoride toothpaste followed by water rinse
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse
Other Intervention Name(s)
Over-the-counter fluoride toothpaste followed by fluoride rinse
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Colgate PreviDent 5000+ toothpaste
Other Intervention Name(s)
Prescription fluoride toothpaste followed by water rinse
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse
Other Intervention Name(s)
Prescription fluoride toothpaste followed by fluoride rinse
Intervention Description
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
Primary Outcome Measure Information:
Title
Area under the curve of fluoride bioavailability in saliva
Description
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
Time Frame
0 to 60 minutes after the interventions
Secondary Outcome Measure Information:
Title
Maximum fluoride concentration in saliva
Description
From the area under the curve, the time at which the concentration in saliva is highest will be determined
Time Frame
0 to 60 minutes after the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
School of Dentistry, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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