Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model

Caries Clinical Trial

Official title:

Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06140758
• Other study ID #: 2022085
• Status: Completed
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: December 11, 2023

Study information

• Verified date: February 2024
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Caries

Intervention

Drug:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Australia	University of Melbourne	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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