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Trial registered on ANZCTR


Registration number
ACTRN12622000306718
Ethics application status
Approved
Date submitted
8/02/2022
Date registered
17/02/2022
Date last updated
22/02/2022
Date data sharing statement initially provided
17/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of the effects of two oral care products on early tooth decay.
Scientific title
Evaluation of the effect of stannous fluoride and Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) -containing oral care products on remineralisation of enamel subsurface lesions in healthy volunteers wearing a palatal appliance with enamel slabs in a double-blind randomised in situ clinical trial
Secondary ID [1] 306333 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 325130 0
Condition category
Condition code
Oral and Gastrointestinal 322537 322537 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
This study will investigate the remineralisation (repair) of early decay-like lesions in tooth enamel after rinsing with two tooth crème/paste slurries prepared by diluting, in distilled filtered (DF) water, tooth crème/pastes containing: (i) a major milk protein casein, combined with calcium and phosphate called CPP-ACP and stannous (tin) fluoride; (ii) stannous fluoride alone. Each treatment will consist of a 1 min rinse with 5 ml of suspension (1g of product suspended in 4 ml Milli Q water) four times a day for 14 consecutive days. One treatment will be a tooth creme/paste slurries containing 1% of CPP-ACP, 220ppm microgram per milliliter of stannous fluoride; and another treatment will be a tooth crème/paste slurries containing 220ppm microgram per milliliter of stannous fluoride alone as control. The Results of this study may provide valuable data assisting further development of a treatment based on CPP-ACP with stannous fluoride that can effectively promote remineralisation (repair) early decay-like lesions in tooth enamel and dentine.
This in situ clinical study will use a randomized, double-blind, crossover design to assess the effects after rinsing with two tooth crème/paste slurries on promoting enamel and dentine remineralization using an intra-oral remineralization model.
Participants will wear a custom-made removable palatal acrylic appliance for 14 consecutive days in each of the two treatment periods. The appliances will be fabricated for the participants under the direct supervision of a registered prosthetist/dental technician at the Royal Dental Hospital of Melbourne. Palatal appliances will contain four presterilized enamel and dentine slabs with demineralised lesions. Participants will wear the appliance for 40 minutes four times a day for two 14-day treatment periods. Participants will be required to rinse with the slurry at the following times: 9.30 am, 11.00 am, 1.30 pm and 3.30 pm, and to keep a record of the time in the diary provided for appliance worn. During the treatment periods, participants will not eat or drink anything when wearing their appliance and will not wear their appliance when participating in sporting activities. The entire project period will comprise a total of five weeks including one-week washout periods between treatments. During the entire five-week project period they will be instructed to brush their teeth twice a day (i.e. start of the day and end of the day) with a toothbrush and a standard fluoride toothpaste (both supplied) with the appliance out of their mouths during the treatment periods.
The study will be carried out at Melbourne Dental School, University of Melbourne at Royal Dental Hospital of Melbourne.


Intervention code [1] 322770 0
Treatment: Other
Comparator / control treatment
The "comparator" is the paste slurry that will contain stannous fluoride alone.
Control group
Active

Outcomes
Primary outcome [1] 330336 0
Remineralisation of artificially-created enamel subsurface carious lesions measured by calculating the difference in mineral content of lesions exposed to the paste slurries, using microdensitometric analysis of microradiographic images of the lesions.
Timepoint [1] 330336 0
14 days post-intervention commencement.
Secondary outcome [1] 405858 0
Remineralisation of dentine subsurface carious lesions assessed using microdensitometric analysis of microradiographic images of the lesions.
Timepoint [1] 405858 0
14 days post-intervention commencement.
Secondary outcome [2] 406096 0
Occlusion of the microscopic tubules in dentine assessed using a scanning electron microscope.
Timepoint [2] 406096 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 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)
Participants will be randomly allocated to one of the two paste slurries during the first treatment period and cross over to the paste slurries during the second treatment period. The order the two paste slurries are allocated to each participant will be random and unknown to the participants or the researchers analyzing the results.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomization procedure
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
7/03/2022
Actual
Date of last data collection
Anticipated
18/04/2022
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 36684 0
3052 - Melbourne University

Funding & Sponsors
Funding source category [1] 310687 0
University
Name [1] 310687 0
Oral Health CRC, University of Melbourne
Country [1] 310687 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville Victoria 3010
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 311906 0
None
Name [1] 311906 0
Address [1] 311906 0
Country [1] 311906 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310271 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 310271 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] 310271 0
Australia
Date submitted for ethics approval [1] 310271 0
26/11/2021
Approval date [1] 310271 0
10/02/2022
Ethics approval number [1] 310271 0

Summary
Brief summary
The study is to compare the remineralisation (repair) of early decay-like lesions in tooth after rinsing with two tooth crème/paste slurries prepared containing: (i) a major milk protein casein, combined with calcium and phosphate (CPP-ACP) and stannous (tin) fluoride (Treatment A); (ii) stannous fluoride alone (Treatment B) in a randomized, double-blind trial. All participants will wear palatal appliances for 14 consecutive days in each of the two treatment periods. This study hypothesis is that treatment A that contains 1% of CPP-ACP with 220ppm fluoride as stannous (tin) fluoride, will enhance remineralisation compared to Treatment B containing 220ppm fluoride as stannous (tin) fluoride alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117078 0
Prof Eric Reynolds
Address 117078 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 117078 0
Australia
Phone 117078 0
+61 3 9341 1547
Fax 117078 0
Email 117078 0
[email protected]
Contact person for public queries
Name 117079 0
Eric Reynolds
Address 117079 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 117079 0
Australia
Phone 117079 0
+61 3 9341 1547
Fax 117079 0
Email 117079 0
[email protected]
Contact person for scientific queries
Name 117080 0
Eric Reynolds
Address 117080 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 117080 0
Australia
Phone 117080 0
+61 3 9341 1547
Fax 117080 0
Email 117080 0
[email protected]

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
14950Informed consent form    383505-(Uploaded-04-02-2022-16-25-16)-Study-related document.pdf



Results publications and other study-related documents

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