A longitudinal study of caries development in children from 4 to 15 years of age

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000325000

Acronym

ECC 4-15

Enrollment

491

Registered

2010-04-21

Start date

2011-01-01

Completion date

2013-01-01

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

4 Years to 15 Years

Healthy volunteers

Yes

Inclusion criteria

All children who complete research study "A longitudinal study of caries prevention in children aged two to four years"

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.

Outcome results