Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000325000
Ethics application status
Approved
Date submitted
18/04/2010
Date registered
21/04/2010
Date last updated
1/12/2020
Date data sharing statement initially provided
17/07/2019
Date results information initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A longitudinal study of caries development in children from 4 to 15 years of age
Scientific title
A randomised phase III study to determine the longitudinal effects of chlorhexidine toothpaste and Casein Phosphopeptide- Amorphous Calcium Phosphate (CPP-ACP Tooth Mousse) in the treatment of dental caries in children to prevent new lesions
Secondary ID [1] 251638 0
"None"
Universal Trial Number (UTN)
Trial acronym
ECC 4-15
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 257206 0
Condition category
Condition code
Oral and Gastrointestinal 257349 257349 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 is a continuation of study "A longitudinal study of caries prevention in children aged two to four years" ACTRN12609000330246 and will be recruiting participants who have already undergone and will continue to undergo two interventions arms. Either brushing teeth with fluoridated toothpaste in combination with CPP-ACP Tooth Mousse or brushing teeth with fluoridated toothpaste in combination with 0.12% chlorhexidine toothpaste from 4 years until 7 years of age.
Intervention code [1] 256332 0
Prevention
Comparator / control treatment
Control group is toothbrushing daily with only fluoridated toothpaste
Control group
Active

Outcomes
Primary outcome [1] 258248 0
Less numbers of carious lesions and or demineralised tooth surfaces as detected through visual examination.
Timepoint [1] 258248 0
6 monthly starting when a child is 4.5 years of age and then once when they are 12 years of age and once when they are 15 years of age
Primary outcome [2] 258249 0
Less numbers of teeth with erosion as determined through visual examination.
Timepoint [2] 258249 0
6 monthly starting when a child is 4.5 years of age and then once when they are 12 years of age and once when they are 15 years of age
Secondary outcome [1] 263906 0
Lower levels of decay causing bacteria as detected through Caries Risk Test (CRT) Bacteria Test by Ivoclar.
Timepoint [1] 263906 0
6 monthly starting when a child is 4.5 years of age and then once when they are 12 years of age and once when they are 15 years of age

Eligibility
Key inclusion criteria
All children who complete research study "A longitudinal study of caries prevention in children aged two to four years"
Minimum age
4 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children who are diagnosed with milk protein allergies will be removed from the intervention group of Tooth Mousse and continue the project in the Fluoride only group.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Continuation of previously randomised product use as per allocation by opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Continuation of simple randomisation by using procedures such as coin tossing and dice rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
1/01/2013
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
2100
Accrual to date
Final
491
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 2828 0
4114

Funding & Sponsors
Funding source category [1] 256836 0
Government body
Name [1] 256836 0
Metro South Health Service District, Oral Health Program, Logan Beaudesert Division
Country [1] 256836 0
Australia
Primary sponsor type
Government body
Name
Metro South Health Service District, Oral Health Program, Logan Beaudesert Division
Address
Kingston Oral Health Centre, Juers St Kingston, Qld 4114
Country
Australia
Secondary sponsor category [1] 256111 0
None
Name [1] 256111 0
Address [1] 256111 0
Country [1] 256111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258853 0
Metro South Health Service District (HSD) Human Research Ethics Committee (HREC)
Ethics committee address [1] 258853 0
Level 2, Building 35, Princess Alexandra Hospital,
Ipswich Road, Woolloongabba, QLD 4102
Ethics committee country [1] 258853 0
Australia
Date submitted for ethics approval [1] 258853 0
10/05/2010
Approval date [1] 258853 0
13/10/2010
Ethics approval number [1] 258853 0
Ethics committee name [2] 300662 0
The University of Queensland Dental Sciences Research Ethics Committee
Ethics committee address [2] 300662 0
200 Turbot St Brisbane Queensland 4000
Ethics committee country [2] 300662 0
Australia
Date submitted for ethics approval [2] 300662 0
11/11/2010
Approval date [2] 300662 0
02/12/2010
Ethics approval number [2] 300662 0
1014

Summary
Brief summary
In this study we will continue to follow participants recruited to " A longitudinal study of caries prevention in children aged two to four years" HREC/09/QPAH/158, ACTRN12609000330246 who have undergone preventative methods of education, home visits and toothbrushing with fluoride toothpaste, 0.12% chlorhexideine gel and CPP-ACP Tooth Mousse.

The effectiveness of these strategies will be assessed through
-microbial analysis for the presence of decay causing bacteria
- clinical dental examination data
- statistical analysis of data for case and control groups
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31070 0
Ms Leigh Harrison-Barry
Address 31070 0
Metro South Oral Health, 228 Logan Road, Woolloongabba, QLD, 4102
Country 31070 0
Australia
Phone 31070 0
+617 33171481
Fax 31070 0
+617 33171499
Email 31070 0
[email protected]
Contact person for public queries
Name 14317 0
Ms Leigh Harrison-Barry
Address 14317 0
Metro South Oral Health, 228 Logan Road, Woolloongabba, QLD, 4102
Country 14317 0
Australia
Phone 14317 0
+617 33171481
Fax 14317 0
+617 33171499
Email 14317 0
[email protected]
Contact person for scientific queries
Name 5245 0
Ms Leigh Harrison-Barry
Address 5245 0
Metro South Oral Health, 228 Logan Road, Woolloongabba, QLD, 4102
Country 5245 0
Australia
Phone 5245 0
+617 33171481
Fax 5245 0
+617 33171499
Email 5245 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


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.