Status:
COMPLETED
Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model
Lead Sponsor:
Procter and Gamble
Conditions:
Caries
Eligibility:
All Genders
18-75 years
Phase:
NA
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 slurri...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06140758
Start Date
July 31 2023
End Date
December 11 2023
Last Update
February 29 2024
Active Locations (1)
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1
University of Melbourne
Melbourne, Australia