- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06140758
Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model
February 27, 2024 updated by: Procter and Gamble
Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model
The primary objective is to compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with six different aqueous slurries of toothpaste formulations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Drug: Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice
- Drug: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
- Drug: Toms of Maine 0 ppm Fluoride Dentifrice
- Drug: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice
- Drug: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
- Drug: 1100 ppm (0.454% Stannous fluoride) Dentifrice
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Melbourne, Australia
- University of Melbourne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be 18-75 years of age.
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form.
- Be in good general health based on medical/dental history and oral exam.
- Have no history of adverse or allergic reactions to tin or tin-containing products.
- Agree not to participate in any other oral study for the study duration.
- Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance.
- Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time.
- Be willing to refrain from using non-study dentifrice, mouth rinse, chewing gum, and other non-study oral care products during the study.
- Be willing to postpone all elective dental procedures until the study has been completed.
- Be willing to refrain from using calcium chews while using the test products.
- Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).
- Ability to understand, and ability to read and sign, the informed consent form.
- Have at least 22 natural teeth.
- Have a gum-stimulated whole salivary flow rate ≥ 1.0 ml/minute and unstimulated whole salivary flow rate ≥ 0.2 ml/minute.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice
|
Each subject will use this product during one of the six treatment periods in the crossover study design.
|
Active Comparator: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
|
Each subject will use this product during one of the six treatment periods in the crossover study design.
|
Sham Comparator: Toms of Maine 0 ppm Fluoride Dentifrice
|
Each subject will use this product during one of the six treatment periods in the crossover study design.
|
Active Comparator: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice
|
Each subject will use this product during one of the six treatment periods in the crossover study design.
|
Active Comparator: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
|
Each subject will use this product during one of the six treatment periods in the crossover study design.
|
Active Comparator: 1100 ppm (0.454% Stannous fluoride) Dentifrice
|
Each subject will use this product during one of the six treatment periods in the crossover study design.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mineral Density
Time Frame: 14 days
|
The percent mineral profile of each enamel/dentinel slab's demineralized control and remineralized/treated lesion, obtained from the microdensitometry analysis, will be compared with the median sound enamel percent mineral profile of the same section.
A negative value indicates mineral has been lost and, therefore, the lesion has progressed, whereas a positive value indicates mineral has been gained and, therefore, the lesion has regressed.
|
14 days
|
Scanning Electron Microscopy (SEM)
Time Frame: 14 days
|
SEM imaging and SEM-EDS analysis will be conducted on TMR sections and whole sections of dentine lesions treated in situ to assess the occlusion of dentine tubules and distribution of elements within the lesions following the experiment.
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2023
Primary Completion (Actual)
December 11, 2023
Study Completion (Actual)
December 11, 2023
Study Registration Dates
First Submitted
November 14, 2023
First Submitted That Met QC Criteria
November 14, 2023
First Posted (Actual)
November 20, 2023
Study Record Updates
Last Update Posted (Estimated)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022085
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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