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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
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Scientific title
Evaluation of Efficacy of New Dentifrice Formulations Containing Different Forms of Fluoride and other Agents to Remineralize Enamel Subsurface Lesions In Situ
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Secondary ID [1]
309330
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
dental caries
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enamel demineralization
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Condition category
Condition code
Oral and Gastrointestinal
326465
326465
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
325764
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Treatment: Other
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Baseline before intervention, and 14 days post-intervention commencement.
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Secondary outcome [1]
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Closure of dentine tubules will be analyzed with microscopy.
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Assessment method [1]
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Timepoint [1]
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Baseline before intervention, and 14 days post-intervention commencement.
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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14 days post-intervention commencement.
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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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/05/2023
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Actual
6/06/2023
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Date of last participant enrolment
Anticipated
22/05/2023
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Actual
21/06/2023
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Date of last data collection
Anticipated
29/09/2023
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Actual
11/12/2023
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Sample size
Target
12
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
39993
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3052 - Melbourne University
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Procter & Gamble
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Address [1]
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Procter & Gamble | Oral Care Clinical Operations
8700 Mason Montgomery Road, Mason, OH 45040
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Procter & Gamble
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Address
Procter & Gamble | Oral Care Clinical Operations
8700 Mason Montgomery Road, Mason, OH 45040
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Melbourne Central Human Research Ethics Committee
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Ethics committee address [1]
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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
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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17/04/2023
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Approval date [1]
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05/06/2023
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Ethics approval number [1]
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Ethics application ID 26846.
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Eric Reynolds
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Address
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Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
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Country
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Australia
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Phone
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+61 3 9341 1547
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Eric Reynolds
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Address
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Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
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Country
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Australia
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Phone
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+61 3 9341 1547
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Eric Reynolds
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Address
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Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
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Country
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Australia
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Phone
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+61 3 9341 1547
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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