Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000653460
Ethics application status
Approved
Date submitted
19/12/2007
Date registered
20/12/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The repair of early tooth decay after rinsing with two solutions, one containing fluoride and a major component of milk called casein, and another containing fluoride only.
Scientific title
The Remineralization of Subsurface Enamel Carious Lesions in situ by Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) and 900 ppm fluoride in Tooth Mousse Plus™, and 5000 ppm fluoride in Neutrafluor 5000™
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early (subsurface) enamel caries 2622 0
Condition category
Condition code
Oral and Gastrointestinal 2729 2729 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
Rinsing with 1:4 dilutions in distilled deionized water of: 1) a tooth creme product containing 10% weight per volume(w/w) casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and 900 parts per million (ppm) sodium fluoride (final concentration 2% (w/v) CPP-ACP and 180 ppm fluoride); 2) an oral care product containing 5000 ppm sodium fluoride (final concentration 1000 ppm fluoride).
The subjects will each wear an upper removable custom-made denture-like appliance that will hold four pre-sterilized enamel pieces each. These enamel pieces will contain artificially-created subsurface carious lesions. The appliances with attached enamel pieces will be worn by the subjects for 40 minutes four times a day for 10 consecutive days and worn immediately before rinsing with the solution. Subjects will also rinse with the solution for 60 seconds four times a day immediately after inserting the appliance each time. After 10 days, the enamel pieces will be removed from the appliance and replaced with new enamel pieces containing the subsurface lesions for the next treatment period.
This is a cross over trial - each participant will rinse with either the intervention or control solution (randomly allocated) for the first 10 days and then crossover to rinse with the other solution for another 10 days after a four day washout period between.
Intervention code [1] 2350 0
Treatment: Other
Comparator / control treatment
Mouthrinse made from 1:4 dilution in distilled deionized water of a commercially-available oral care product containing 5000 ppm fluoride (mouthrinse therefore contains 1000 ppm fluoride).
Subjects will rinse with this solution four times a day, for 60 seconds each time, over 10 consecutive days.
Subjects will wear the appliances holding pre-sterilized enamel pieces containing artificially-created subsurface carious lesions as per the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 3627 0
Remineralization of artificially-created subsurface carious lesions measured by calculating the difference in mineral content in lesions exposed to the solutions and the mineral content of the respective control lesions (not exposed to the solutions), using microdensitometric analysis of microradiographic images of the lesions.
Timepoint [1] 3627 0
Mineral content will be measured once at the end of 10 days' rinsing with each of the two solutions.
Secondary outcome [1] 6079 0
N/A
Timepoint [1] 6079 0
N/A

Eligibility
Key inclusion criteria
Adults in good general and dental health
Have at least 22 teeth
Produce normal amounts of saliva (determined by measuring the volume of a two-minute unstimulated saliva sample and a two-minute stimulated saliva sample).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergic or adverse reactions to milk or milk products.
History of dry mouth, or medical conditions or taking medication likely to cause xerostomia.
Bleeding disorders.
Infectious diseases including blood-borne diseases such as HIV/AIDS; or Hepatitis C.
Active dental caries or periodontal diseases.
History of rheumatic heart disease, heart murmurs, etc. where risk of complications following bacteremia is present.
pregnancy.

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)
The institution will be provided with the products in packets as they are marketed. Participants will be enrolled after they have fulfilled inclusion criiteria and do not have any of the medical or dental conditions that would exclude them from the study. They will sign a written consent form before participating. Allocation of products to participants will be random. Each participant will be given a coded plastic tube each day containing freshly prepared solution allocated to them. The code will only be known to researchers preparing the solutions from these products to give to the participants. Therefore, the sequence of treatments for each subject will only be known to the researchers preparing the solutions and not the participants or the researchers measuring mineral content in the enamel lesions or analyzing the remineralization data collected. In the case of a medical emergency, the code can be accessed for a single participant without breaking the blinding for other participants.
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?



Intervention assignment
Crossover
Other design features
This a two-way crossover study with a washout period of four days between treatments.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2877 0
Commercial sector/Industry
Name [1] 2877 0
Co-operative Research Centre for Oral Health Sciences
Country [1] 2877 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 2592 0
Commercial sector/Industry
Name [1] 2592 0
GC Corporation
Address [1] 2592 0
76-1 Hasunuma-cho
Itabashi-ku
Tokoyo 174-8585
Country [1] 2592 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4811 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 4811 0
Ethics Office
Melbourne Research Office
Level 5
Alan Gilbert Building
161 Barry Street
University Square
Carlton VIC 3052
Ethics committee country [1] 4811 0
Australia
Date submitted for ethics approval [1] 4811 0
14/08/2007
Approval date [1] 4811 0
23/11/2007
Ethics approval number [1] 4811 0
0712157

Summary
Brief summary
The aim of this study is to compare the repair of early tooth decay and penetration of fluoride into the repaired decay after mouthrinsing four times a day for 10 days with a solution of: 1) a tooth creme product containing fluoride and a major component of milk called casein; 2) an oral care product containing fluoride alone.
Subjects will wear a custom-made removable plastic denture-like appliance that will each hold four pieces of pre-sterilized human tooth enamel containing early decay that has been artificially-created in the laboratory. Subjects will insert their appliance, rinse with 5 mL of one of the two solutions for one minute, spit out the solution, then continue wearing the appliance for a total of 40 minutes. After 10 days' rinsing with one of the solutions, subjects will rest from the study for four days before repeating the exercise with the other solution as before.
The research team will prepare the solutions by diluting the products in distilled filtered water. Solutions will be freshly prepared for use at the start of each weekday and enough solution for subjects to use on the weekends will be prepared on the Friday beforehand.
Subjects will brush their teeth with a fluoride toothpaste at least one hour before first inserting their appliance that day and rinse their mouths with tap water and their appliance with distilled filtered water immediately prior to inserting their appliance each time. They will also rinse their appliance with distilled filtered water after removing it each time and store their appliance in a humid container at room temperature. Subjects will also be instructed to clean their appliance, avoiding the enamel pieces, with a fluoride-free denture paste once daily. The solutions will be stored at room temperature at all times. Subjects will not eat or drink anything except rinse with their allocated solution when wearing their appliance. Otherwise, subjects will maintain their normal oral hygiene and dietary habits throughout the study.
The hypotheses for this study are:
1) there will be significantly greater repair of decay after rinsing with the solution containing casein and fluoride than after rinsing with the solution containing fluoride only.
2) penetration of fluoride into the repaired decay will be significantly greater after rinsing with the solution containing casein and fluoride than the solution containing fluoride alone.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 28234 0
Address 28234 0
Country 28234 0
Phone 28234 0
Fax 28234 0
Email 28234 0
Contact person for public queries
Name 11391 0
Professor Eric Reynolds AO
Address 11391 0
School of Dental Science
University of Melbourne
720 Swanston St
Melbourne VIC 3010
Country 11391 0
Australia
Phone 11391 0
+61 3 93411547
Fax 11391 0
+61 3 93411596
Email 11391 0
[email protected]
Contact person for scientific queries
Name 2319 0
Professor Eric Reynolds AO
Address 2319 0
School of Dental Science
University of Melbourne
720 Swanston St
Melbourne VIC 3010
Country 2319 0
Australia
Phone 2319 0
+61 3 93411547
Fax 2319 0
+61 3 93411596
Email 2319 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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