Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000381684
Ethics application status
Approved
Date submitted
29/03/2023
Date registered
14/04/2023
Date last updated
7/04/2024
Date data sharing statement initially provided
14/04/2023
Date results information initially provided
7/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model
Scientific title
Evaluation of Efficacy of New Dentifrice Formulations Containing Different Forms of Fluoride and other Agents to Remineralize Enamel Subsurface Lesions In Situ
Secondary ID [1] 309330 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries
329528 0
enamel demineralization 329530 0
Condition category
Condition code
Oral and Gastrointestinal 326465 326465 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twelve healthy adult participants will be recruited on a purely voluntary basis and will be free to exit the study at any time. Each participant will wear an upper custom-made removable denture-like appliance with pre- sterilized human enamel and dentine slabs containing artificially-created early decay attached. To allow dental plaque to form on the slabs participants will wear the appliances 24 hours a day except whenever eating or drinking and cleaning their teeth and appliance and participating in sporting activities. The dosage form of the treatment products is a dentifrice slurry. Each slurry of dentifrice will be prepared by diluting 1 g of the product in 4 mL of distilled de-ionized water in a 15mL tube. There will be six treatment periods each preceded by a one-week washout period during which participants will rest from the study. The investigational toothpaste products are:
Experimental 1: MFP/CaCO3 Anticavity Toothpaste (1.16% ppm MFP, 1500 ppm F-); Experimental 2: SnF2/Silica Anticavity Toothpaste (0.454% stannous fluoride (SnF2), 1100 ppm F-).
Participants will be randomly allocated to one of the six products consisting of 4 controls (see below) and 2 experimental treatments at the first treatment period. At each treatment period, participants will receive their assigned treatment product (in a slurry) and wear their palatal appliance all day for 14 consecutive days. Four times a day at 9:30 am, 11:00 am, 1:30 pm and 3:30 pm, participants will firstly rinse with 5 mL of a 10% sucrose solution (supplied) for 60 seconds and expectorate. Forty minutes after each sucrose rinse, participants will shake their product slurry and immediately rinse with all 5 mL of their allocated slurry for 60 seconds (i.e. four times a day at 10:10 am, 11:40 am, 2:10 pm and 4:10 pm). Participant will be required to record sugar solution rinse time, slurry rinse time and appliance wearing time each day on the diary provided. The duration of the intervention will be 15 weeks consisting of 5 x 14-day treatment phases with a 7-day wash-out/rest period between each treatment phase.
Participants will clean their appliance twice a day during treatment periods, avoiding the slabs, with fluoride-free paste (supplied) and rinse their appliances, avoiding the slabs, with distilled filtered (DF) water (supplied).
Participants will brush their teeth twice a day with fluoride toothpaste and toothbrush (supplied). They will be instructed not to use other mouthwashes or consume antibacterial lozenges or chewing gum during the study but will otherwise continue normal oral hygiene and dietary habits. At the start of each weekday, participants will be given enough solution and slurry to rinse with that day and, on Fridays, will be given enough solution and slurry to use over the following weekend. They will store their solutions and slurries in a refrigerator over the weekend and allow them to warm to room temperature before rinsing. The solutions and slurries will be prepared by the research team using DF water. There will be at least a week’s rest between each treatment period with a different slurry allocated for each treatment period. The order of slurries for each participant will be unknown to the participants or researchers.
Participant will be paid $500 per 14-day treatment period and $3,000 for the 6 treatment study for their time and commitment.
Intervention code [1] 325764 0
Treatment: Other
Comparator / control treatment
Positive Control: Crest® Salt White (1.10% sodium monofluorophosphate (MFP), 1450 ppm Fluoride (F-))
Marketed Control 1: Colgate® Maximum Cavity Protection Fluoride Toothpaste with Sugar Acid Neutraliser (1.16% MFP, 1450 ppm F-, 1.5% Arginine (Arg)).
Marketed Control 2: Tom’s of Maine Rapid Relief Sensitive Toothpaste (8% Arginine)
Marketed Control 3: Colgate® Sensitive Pro-Relief Extra Protect Fluoride Toothpaste (1.1% MFP, 1450 ppm F-, 8% Arginine).
Control group
Active

Outcomes
Primary outcome [1] 334312 0
Any change in the mineralisation content of white spots lesions in enamel and dentine slabs measured by calculating the difference in mineral content of lesions exposed to the oral care agents, using microdensitometric analysis of microradiographic images of the lesions.
Timepoint [1] 334312 0

Baseline before intervention, and 14 days post-intervention commencement.
Secondary outcome [1] 420216 0
Closure of dentine tubules will be analyzed with microscopy.
Timepoint [1] 420216 0

Baseline before intervention, and 14 days post-intervention commencement.
Secondary outcome [2] 420441 0
Levels of elements such as fluoride in repaired decay and in saliva, will also be assessed using Scanning electron microscopy (SEM)/energy dispersive X-ray spectroscopy (EDS) and Ion Chromatography respectively.
Timepoint [2] 420441 0
14 days post-intervention commencement.

Eligibility
Key inclusion criteria
Inclusion Criteria
Age range: 18 to 75 years.
Gender: Males and females.
Good general health.
At least 22 natural teeth.
A gum- stimulated whole salivary flow rate at least 1.0 ml/minute and unstimulated whole salivary flowrate at least 0.2 ml/minute. Available for both treatment periods.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria include:
1) History of adverse or allergic reactions to tin or tin-containing products, arginine or any other ingredients in the toothpaste products;
2) Orthodontic appliances or removable dentures;
3) Veneers, or more than one incisor with an artificial crown;
4) Oral diseases including advanced periodontal disease;
5) Chronic disease such as diabetes or use of medications that cause gum swelling;
6) Untreated decay;
7) Treatment with antibiotics or anti-infl ammatory medicines in the month prior to starting the study;
8) Use of drugs that may interact with the toothpaste slurries or which may aff ect salivary fl ow rate;
9) History of health conditions requiring antibiotic coverage prior to dental treatment;
10) Pregnancy/lactation;
11) Serious infectious disease;
12) Any other medical or dental condition deemed to put the health and wellbeing of you or the research team at risk if you 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2023
Actual
6/06/2023
Date of last participant enrolment
Anticipated
22/05/2023
Actual
21/06/2023
Date of last data collection
Anticipated
29/09/2023
Actual
11/12/2023
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 39993 0
3052 - Melbourne University

Funding & Sponsors
Funding source category [1] 313528 0
Commercial sector/Industry
Name [1] 313528 0
Procter & Gamble
Country [1] 313528 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Procter & Gamble
Address
Procter & Gamble | Oral Care Clinical Operations
8700 Mason Montgomery Road, Mason, OH 45040
Country
United States of America
Secondary sponsor category [1] 315308 0
None
Name [1] 315308 0
Address [1] 315308 0
Country [1] 315308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312713 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 312713 0
Office of Research Ethics and Integrity | Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010, Australia
Ethics committee country [1] 312713 0
Australia
Date submitted for ethics approval [1] 312713 0
17/04/2023
Approval date [1] 312713 0
05/06/2023
Ethics approval number [1] 312713 0
Ethics application ID 26846.

Summary
Brief summary
To evaluate the effects of oral care agents on white spots, healthy human participants will wear appliances with tooth slabs containing artificially-created early decay (white spots) attached. During each 14-day treatment period, a slurry of each dentifrice formulation will be prepared by diluting 1 g of the product in 4 mL of distilled de-ionized water in a 15mL tube. Four times a day at 9:30 am, 11:00 am, 1:30 pm and 3:30 pm, participants will rinse with 5 mL of a 10% sucrose solution (supplied) for 60 seconds. They will expectorate the sucrose rinse after 60 seconds. Forty minutes after each sucrose rinse, participants will shake their slurry solution and immediately rinse with all 5 mL of their allocated slurry for 60 seconds (i.e. four times a day at 10:10 am, 11:40 am, 2:10 pm and 4:10 pm). They will then expectorate the slurry. Participants will (gently) remove their appliances only when they brush their teeth and clean their appliances in the morning and at night without touching the wells holding the enamel/dentine pieces. There will be at least a week’s rest between each treatment period with a different slurry allocated for each treatment period. The order of slurries for each participant will be unknown to the participants or researchers. At the end of each treatment period, the slabs from the appliance will be returned and x-rayed outside the mouth to measure repair of decay. Closure of dentine tubules will be analyzed with microscopy. This project will provide valuable information for development of novel toothpastes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125642 0
Prof Eric Reynolds
Address 125642 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 125642 0
Australia
Phone 125642 0
+61 3 9341 1547
Fax 125642 0
Email 125642 0
e.reynolds@unimelb.edu.au
Contact person for public queries
Name 125643 0
Prof Eric Reynolds
Address 125643 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 125643 0
Australia
Phone 125643 0
+61 3 9341 1547
Fax 125643 0
Email 125643 0
e.reynolds@unimelb.edu.au
Contact person for scientific queries
Name 125644 0
Prof Eric Reynolds
Address 125644 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 125644 0
Australia
Phone 125644 0
+61 3 9341 1547
Fax 125644 0
Email 125644 0
e.reynolds@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.