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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06140758




Registration number
NCT06140758
Ethics application status
Date submitted
14/11/2023
Date registered
20/11/2023
Date last updated
29/02/2024

Titles & IDs
Public title
Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model
Scientific title
Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model
Secondary ID [1] 0 0
2022085
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caries 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral-B 1450 ppm Fluoride (1.16% sodium monofluorophosphate) Dentifrice
Treatment: Drugs - Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice
Treatment: Drugs - Toms of Maine 0 ppm Fluoride Dentifrice
Treatment: Drugs - Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice
Treatment: Drugs - 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice
Treatment: Drugs - 1100 ppm (0.454% Stannous fluoride) Dentifrice

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

Active comparator: Colgate 1450 ppm Fluoride (1.16% sodium monofluorophosphate)Dentifrice -

Sham comparator: Toms of Maine 0 ppm Fluoride Dentifrice -

Active comparator: Colgate 1450 ppm Fluoride (1.1% sodium monofluorophosphate) Dentifrice -

Active comparator: 1500 ppm MFP/CaCO3 1.16% sodium monofluorophosphate) Dentifrice -

Active comparator: 1100 ppm (0.454% Stannous fluoride) Dentifrice -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mineral Density
Timepoint [1] 0 0
14 days
Primary outcome [2] 0 0
Scanning Electron Microscopy (SEM)
Timepoint [2] 0 0
14 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2023
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Procter and Gamble
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06140758