Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2023
CompletedFirst Submitted
Initial submission to the registry
November 14, 2023
CompletedFirst Posted
Study publicly available on registry
November 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2023
CompletedFebruary 29, 2024
February 1, 2024
4 months
November 14, 2023
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Mineral Density
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)
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
Study Arms (6)
Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice
ACTIVE COMPARATORColgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
ACTIVE COMPARATORToms of Maine 0 ppm Fluoride Dentifrice
SHAM COMPARATORColgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice
ACTIVE COMPARATOR1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
ACTIVE COMPARATOR1100 ppm (0.454% Stannous fluoride) Dentifrice
ACTIVE COMPARATORInterventions
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Each subject will use this product during one of the six treatment periods in the crossover study design.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Melbourne
Melbourne, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2023
First Posted
November 20, 2023
Study Start
July 31, 2023
Primary Completion
December 11, 2023
Study Completion
December 11, 2023
Last Updated
February 29, 2024
Record last verified: 2024-02