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Completed

NCT Number: NCT06140758

Evaluation of the Anticaries Efficacy of 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.

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Key information

Conditions

Caries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Melbourne

Melbourne, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

Each subject will use this product during one of the six treatment periods in the crossover study design.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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