Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000421437
Ethics application status
Approved
Date submitted
14/08/2007
Date registered
21/08/2007
Date last updated
2/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical trial of a tooth cream in the repair of early dental decay.
Scientific title
A three-month, double-blind, parallel-group, placebo-controlled randomized clinical trial to investigate the remineralizing capacity of casein phosphopeptide-amorphous calcium phosphate in a post-orthodontic population.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caries 2253 0
Condition category
Condition code
Oral and Gastrointestinal 2345 2345 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
Tooth Mousse (containing casein phosphopeptide-amorphous calcium phosphate nanocomplexes (CPP-ACP). Tooth Mousse contains 10% w/v CPP-ACP. Dosage is 1ml Tooth Mousse twice daily for 12 weeks.
Intervention code [1] 1965 0
Treatment: Devices
Comparator / control treatment
Placebo. The placebo is a neutral mousse, identical in formulation to the Tooth Mousse, but not containing CPP-ACP.
Control group
Placebo

Outcomes
Primary outcome [1] 3239 0
To investigate in vivo the capacity of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in Tooth Mousse to remineralize enamel white spot lesions in a post-orthodontic population as measured by change in Clinical Assessment score of a white spot lesion from baseline to 12 weeks.
Timepoint [1] 3239 0
Measurements will be taken at baseline, 4, 8 and 12 weeks.
Secondary outcome [1] 5407 0
To investigate in vivo the capacity of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in Tooth Mousse to remineralize enamel white spot lesions in a post-orthodontic population as measured by change in Clinical Assessment score of a white spot lesion from baseline to 4 and 8 weeks.
Timepoint [1] 5407 0
Baseline to 4 and 8 weeks

Eligibility
Key inclusion criteria
Undergoing fixed orthodontic treatment and due to have appliances removed during study period.
Exhibiting a minimum of two WSLs on the buccal surfaces of teeth 14 to 44 (or 15 to 45 when first premolars have been extracted) at time of recruitment.
Able to attend for four visits over a 12 week period.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a.Allergies to milk proteins.
b.Ulcerative mucosal conditions.
c.Chronic use of medication causing xerostomia.
d.Allergies to preservatives (or other ingredients) present in Tooth Mousse or placebo.
e.Unrestored dentinal caries in teeth 14 to 44 (or 15 to 45).
f.Pregnancy.
g.Any other illnesses/conditions that the Investigator deems could affect the study outcome.

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)
Allocation was concealed. All product had previously been de-idenitified, numbered and packaged at a central adminstration site according to the allocation schedule. The Investigator allocated the next available number to each new participant. In the case of medical emergency the treatment code could be accessed for a single subject without breaking the blind for other subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated block randomization schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2501 0
Other Collaborative groups
Name [1] 2501 0
CRC Oral Health Science
Country [1] 2501 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GC Corporation
Address
76-1 Hasunuma-Cho
Itabashi-Ku
Tokyo 174-8585
Country
Japan
Secondary sponsor category [1] 2273 0
Commercial sector/Industry
Name [1] 2273 0
Halas Dental
Address [1] 2273 0
Unit 1-2 44 O'Dea Avenue, Waterloo 2017
Country [1] 2273 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4414 0
University of Melbourne HREC
Ethics committee address [1] 4414 0
Ethics committee country [1] 4414 0
Australia
Date submitted for ethics approval [1] 4414 0
14/12/2004
Approval date [1] 4414 0
Ethics approval number [1] 4414 0
040863

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27983 0
Address 27983 0
Country 27983 0
Phone 27983 0
Fax 27983 0
Email 27983 0
Contact person for public queries
Name 11140 0
Dr Denise Bailey
Address 11140 0
Level 6, 720 Swanston Street
Carlton
VIC 3053
Country 11140 0
Australia
Phone 11140 0
03 9341 1559
Fax 11140 0
03 9341 1559
Email 11140 0
[email protected]
Contact person for scientific queries
Name 2068 0
Dr Denise Bailey
Address 2068 0
Level 6, 720 Swanston Street
Carlton
VIC 3053
Country 2068 0
Australia
Phone 2068 0
03 9341 1559
Fax 2068 0
03 9341 1559
Email 2068 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

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

Documents added automatically
No additional documents have been identified.