Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Not Applicable
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06140758
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