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

Procter & Gamble (P&G)

Status: Completed

Conditions: Caries

Treatments: Drug: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice; Drug: Toms of Maine 0 ppm Fluoride Dentifrice; Drug: Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice; Drug: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice; Drug: 1100 ppm (0.454% Stannous fluoride) Dentifrice; Drug: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT06140758

2022085

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 6 patient groups

Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice

Active Comparator group

Treatment:

Drug: Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice

Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice

Active Comparator group

Treatment:

Drug: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice

Toms of Maine 0 ppm Fluoride Dentifrice

Sham Comparator group

Treatment:

Drug: Toms of Maine 0 ppm Fluoride Dentifrice

Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice

Active Comparator group

Treatment:

Drug: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice

1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice

Active Comparator group

Treatment:

Drug: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice

1100 ppm (0.454% Stannous fluoride) Dentifrice

Active Comparator group

Treatment:

Drug: 1100 ppm (0.454% Stannous fluoride) Dentifrice