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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06140745




Registration number
NCT06140745
Ethics application status
Date submitted
14/11/2023
Date registered
20/11/2023
Date last updated
20/11/2023

Titles & IDs
Public title
Evaluation of Dentifrice Formulations to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind In-Situ Clinical Trial
Scientific title
Evaluation of Efficacy of Experimental Dentifrice Formulations With Different Forms of Fluoride and/or Other Agents to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind Randomized In-Situ Clinical Trial
Secondary ID [1] 0 0
2019176
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 - 0 ppm Fluoride Dentifrice 1
Treatment: Drugs - 1100 ppm NaF Fluoride Dentifrice
Treatment: Drugs - 1500 ppm NaMFP Fluoride Dentifrice
Treatment: Drugs - 0 ppm Fluoride Dentifrice 2
Treatment: Drugs - 0 ppm Fluoride Dentifrice 3

Placebo comparator: 0 ppm Fluoride Dentifrice 1 -

Active comparator: 1100 ppm NaF Fluoride Dentifrice -

Active comparator: 1500 ppm NaMFP Fluoride Dentifrice -

Sham comparator: 0 ppm Fluoride Dentifrice 2 -

Sham comparator: 0 ppm Fluoride Dentifrice 3 -


Treatment: Drugs: 0 ppm Fluoride Dentifrice 1
Each subject will use this product during one of the five treatment periods in the crossover study design.

Treatment: Drugs: 1100 ppm NaF Fluoride Dentifrice
Each subject will use this product during one of the five treatment periods in the crossover study design.

Treatment: Drugs: 1500 ppm NaMFP Fluoride Dentifrice
Each subject will use this product during one of the five treatment periods in the crossover study design.

Treatment: Drugs: 0 ppm Fluoride Dentifrice 2
Each subject will use this product during one of the five treatment periods in the crossover study design.

Treatment: Drugs: 0 ppm Fluoride Dentifrice 3
Each subject will use this product during one of the five 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.
* Willingness to comply with all study procedures and be available for the duration of the study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Advanced periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* Active treatment for periodontitis;
* A medical condition which requires premedication prior to dental visits/procedures;
* Untreated dental problems (e.g. cavities);
* Self-reported pregnancy or plans to become pregnant during the study;
* Existing dental work which prevents wearing of the appliance including orthodontic appliances or removable dentures;
* Chronic disease such as diabetes or use of medications that cause gum swelling;
* Any diseases or conditions (including sensitivity to dentifrice ingredients or a history of allergic or adverse reactions to tin or tin-containing products) that might interfere with examination procedures or the participant safely completing the study;
* Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study;
* Use of drugs that may interact with the toothpaste slurries or which may affect salivary flow rate;
* History of health conditions requiring antibiotic coverage prior to dental treatment;
* Serious infectious disease;
* Any other medical or dental conditions deemed to put the health and wellbeing of the participant or research team at risk if the potential participant participated in the study.

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
5/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2021
Sample size
Target
Accrual to date
Final
10
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
To compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with five different aqueous slurries of toothpaste formulations. Percent remineralization (%R), i.e. the % change in ?Z values relative to ?Zd, will be the primary outcome measure.
Trial website
https://clinicaltrials.gov/study/NCT06140745
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06140745