Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001258741p
Ethics application status
Not yet submitted
Date submitted
15/09/2022
Date registered
20/09/2022
Date last updated
20/09/2022
Date data sharing statement initially provided
20/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effects of topical application of oral care agents on white spots in enamel in healthy adults
Scientific title
Evaluating the effect of topical application of gel containing high concentrations of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) with stannous fluoride on white spot lesions in enamel in situ in healthy adults
Secondary ID [1] 307975 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 327643 0
enamel demineralization 327659 0
Condition category
Condition code
Oral and Gastrointestinal 324727 324727 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
Four human participants aged 18 to 75 years of age who fulfil all eligibility criteria will wear custom-made removable denture-like appliances with pre-sterilized slabs of human tooth enamel containing artificially-created early decay (white spots) attached. The appliances will be worn 24 hours a day (except during eating, drinking and oral hygiene) for 14 consecutive days (weekends included) for each of two treatment periods. During one of the two treatment periods, a gel will be applied to the surface of each enamel slab on the appliance by the research team on Monday and Friday when participant is required to be present (first and second week of each 14-day treatment period). The anticipated duration of each treatment visit will be up to 35 minutes. This topical procedure to be performed by the research team is comprised of a) 20 sec polishing the enamel slab surface with Prophy paste, b) 20 min treatment of enamel slab surface with 17% Carbamide peroxide (CP), and c) 60% casein phosphopeptide-amorphous calcium phosphate + 1100 ppm F as stannous fluoride (CPP-ACP/SnF2) x2. The gel that contains 60% (w/w) the major milk protein casein combined with calcium (CPP-ACP) and 1100 ppm fluoride as stannous fluoride will be prepared by the research team. For each of the two treatment periods, participants will be required to apply a tooth crème/paste containing 10% CPP-ACP and 900 ppm fluoride as sodium fluoride on the enamel slabs on their appliances three times per day for 14 days. Treatment with topical application of the tooth crème/paste alone on the enamel slabs on the appliance three times a day will be used as a control. At the end of the first treatment period participants will rest from the project for a week (washout period), then will commence another treatment with new pre-sterilized enamel attached to their appliance. The order of the treatments will be random and unknown to the researchers analyzing the data. Once a day participants will also be asked to brush the surface of their appliance that contacts the roof of their mouth and the other surface containing the enamel slabs, but avoiding brushing the slabs and surrounding trough areas housing the enamel slabs using a toothbrush and a fluoride-free toothpaste (both supplied). After brushing their appliance, they will gently rinse both surfaces of their appliance with distilled filtered water using a wash bottle (both supplied) but will be instructed to avoid rinsing the enamel pieces and surrounding trough areas on the appliance. Whenever participants are not wearing their appliance, they will be requested to store it in a sealed plastic bag with a few drops of distilled filtered water (both supplied) at room temperature to keep the appliance and enamel slabs from drying out. Participants will not eat or drink anything (including water) when wearing their appliance but will otherwise continue with their normal dietary habits.
Intervention code [1] 324434 0
Treatment: Other
Comparator / control treatment
The "comparator" is tooth crème/paste containing 10% CPP-ACP and 900 ppm fluoride as sodium fluoride alone. Treatment with topical application of the tooth crème/paste alone on the enamel slabs on the appliance three times a day will be used as a control.
Control group
Active

Outcomes
Primary outcome [1] 332546 0
Any change in white spots lesions in enamel slabs measured using image analysis of standardized photographs of the white spots.
Timepoint [1] 332546 0

Baseline before intervention, and 14 days post-intervention commencement.
Secondary outcome [1] 413875 0
Any change in the mineralisation content of white spots lesions in enamel 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] 413875 0

Baseline before intervention, and 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 flow rate 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 milk proteins (such as casein), tin or tin-containing products, or any other ingredients in the
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-inflammatory medicines in the month prior to starting the study;
8) Use of drugs that may interact with the toothpaste slurries or which may affect salivary flow 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
Not yet recruiting
Date of first participant enrolment
Anticipated
24/10/2022
Actual
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
5/12/2022
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38520 0
3052 - Melbourne University

Funding & Sponsors
Funding source category [1] 312243 0
University
Name [1] 312243 0
Oral Health CRC, University of Melbourne
Country [1] 312243 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville Victoria 3010
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 313780 0
None
Name [1] 313780 0
Address [1] 313780 0
Country [1] 313780 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311619 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 311619 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] 311619 0
Australia
Date submitted for ethics approval [1] 311619 0
23/09/2022
Approval date [1] 311619 0
Ethics approval number [1] 311619 0

Summary
Brief summary
To evaluate the effects of oral care agents on white spots, healthy human participants will wear appliances with tooth enamel slabs containing artificially-created early decay (white spots) attached. During one of the two treatment periods, a gel containing oral care agent will be applied to the surface of enamel slabs on the appliance. For each of the two treatment periods, participants will also be required to apply an oral care tooth crème on the enamel slabs on their appliances three times per day for 14 days. After completion of each treatment, the enamel slab surface colour change and mineral content in the white spots will be analysed. The study hypothesis will be that topical application of oral care agents on white spots will have no effects on colour changes and mineral content change in enamel in situ.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121742 0
Prof Eric Reynolds
Address 121742 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 121742 0
Australia
Phone 121742 0
+61 3 9341 1547
Fax 121742 0
Email 121742 0
e.reynolds@unimelb.edu.au
Contact person for public queries
Name 121743 0
Prof Eric Reynolds
Address 121743 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 121743 0
Australia
Phone 121743 0
+61 3 9341 1547
Fax 121743 0
Email 121743 0
e.reynolds@unimelb.edu.au
Contact person for scientific queries
Name 121744 0
Prof Eric Reynolds
Address 121744 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 121744 0
Australia
Phone 121744 0
+61 3 9341 1547
Fax 121744 0
Email 121744 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
IPD data will not be available due to privacy concerns as this study involves only a small number of participants and the potential for data matching with previous studies conducted by the Institution.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17129Informed consent form    384671-(Uploaded-15-09-2022-09-29-45)-Study-related document.pdf



Results publications and other study-related documents

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