Status:
COMPLETED
In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice
Lead Sponsor:
Indiana University
Collaborating Sponsors:
HALEON
Conditions:
Caries
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the remineralization potential of an optimized fluoride dentifrice to a control fluoride dentifrice in an in situ caries model.
Detailed Description
This will be a double blind, single center, 3-way crossover design study. Two to three days before the start of each treatment period the subjects will have their teeth cleaned to remove all accessibl...
Eligibility Criteria
Inclusion
- provide voluntary, written informed consent;
- be between 18 and 85 years old;
- understand and be willing, able and likely to comply with all study procedures and restrictions;
- be wearing a removable mandibular partial denture with sufficient room to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth on the same side;
- be willing and capable of wearing their removable partial denture 24 hours a day for three (3), two-week treatment periods;
- be willing to allow study personnel to drill specimen sites in two denture teeth in the posterior section of one side of their lower partial denture, which may extend into the buccal flange area below the teeth;
- be in good medical and dental health with no active caries or periodontal disease; NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1; and
- have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).
Exclusion
- currently be pregnant, intending to become pregnant during the study period or breast feeding;
- currently have any medical condition that could be expected to interfere with the subject's safety during the study period;
- currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning treatment 1;
- known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients;
- have participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
- be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06010732
Start Date
October 2 2023
End Date
February 22 2024
Last Update
June 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street
Indianapolis, Indiana, United States, 46202