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Trial registered on ANZCTR


Registration number
ACTRN12605000598684
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
5/10/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Remineralisation of decalcified tooth enamel consequent to orthodontic treatment
Scientific title
Remineralisation of decalcified tooth enamel following routine application of fluoride or casein phosphopeptide - amorphous calcium phosphate during in individuals undergoing orthodontic treatment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Enamel demineralisation 727 0
Condition category
Condition code
Oral and Gastrointestinal 804 804 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
Enamel demineralization is a frequent finding during orthodontic treatment, and is associated with poor oral hygiene. This study is directed at determining the optimum agent (or combination of agents) and techniques that will promote maximum resolution of the demineralised enamel lesions. The agents under investigation include single application of Ozone, and routine use of fluoride and casein phosphopeptide - amorphous calcium phosphate.
Intervention code [1] 381 0
None
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 1032 0
The primary outcome that is expected is gradual resolution of the enamel lesions over a period of time.
Timepoint [1] 1032 0
Assessment of the changes will be made every 4 weeks.
Secondary outcome [1] 1921 0
Early detection of enamel lesions and appropriate application of the optimum therapeutic agent to halt and reverse the demineralisation process.
Timepoint [1] 1921 0

Eligibility
Key inclusion criteria
The presence of demineralised enamel lesions.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to milk products.

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)
sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation ie a given number of sealed envelopes are placed within another, and selection (ie generation) is by random selection of envelopes such that within the given block, there will be a certain number within each category.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Each subject serves as their own control (at baseline)
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment outside Australia
Country [1] 175 0
New Zealand
State/province [1] 175 0

Funding & Sponsors
Funding source category [1] 891 0
Other
Name [1] 891 0
Successful research grant
Country [1] 891 0
Primary sponsor type
Individual
Name
Andrew Quick
Address
Country
Secondary sponsor category [1] 753 0
None
Name [1] 753 0
None
Address [1] 753 0
Country [1] 753 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35175 0
Address 35175 0
Country 35175 0
Phone 35175 0
Fax 35175 0
Email 35175 0
Contact person for public queries
Name 9570 0
Andrew Quick
Address 9570 0
School of Dentistry
Discipline of Orthodontics
University of Otago
Box 647
Dunedin
Country 9570 0
New Zealand
Phone 9570 0
+64 3 4797068
Fax 9570 0
+64 3 4797070
Email 9570 0
[email protected]
Contact person for scientific queries
Name 498 0
Andrew Quick
Address 498 0
School of Dentistry
Discipline of Orthodontics
University of Otago
Box 647
Dunedin
Country 498 0
New Zealand
Phone 498 0
+64 3 4797068
Fax 498 0
+64 3 4797070
Email 498 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.