A controlled longitudinal study of caries prevention in children aged 2 to 4 years

A randomised longitudinal phase III study to evaluate the effects of chlorhexidine toothpaste and Casein Phosphopeptide - Amorphous Calcium Phosphate (CPP-ACP Tooth Mousse) in the treatment of condition Early Childhood Caries to prevent carious lesions in deciduous teeth

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000330246

Acronym

ECC2-4

Enrollment

491

Registered

2009-05-22

Start date

2009-09-01

Completion date

2012-06-01

Last updated

2020-01-13

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 be continuing to follow participants recruited for the research project “Preventive Strategies for Early Childhood Caries from Antenatal to age 24 months" Princess Alexandra (PA) Ethics no. 2006/145, and Australian Clinical Trials Registry (ACTR) registration number ACTRN012606000356561 who have undergone preventative methods of education, home visits and toothbrushing with low-dose fluoride toothpaste, 0.2% chlorhexidine gel and casein-phosphopeptide amorphous calcium phosphate (CPP-ACP, ToothMousse). The effectiveness of these strategies will be assessed through - Pre- and post questionnaires - microbial analysis for the presence of decay causing bacteria - dental screen analysis for all participants at age 3 and 4 - statistical analysis of data for case and control groups

Interventions

Toothbrushing daily only with low dose fluoride toothpaste or in combination with either CPP-ACP Tooth Mousse or 0.2% chlorhexidine toothpaste from 2 to four 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

16 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

All mothers who completed research Study "Preventive Strategies for Early Childhood Caries from Antenatal to age 24 months"

Exclusion criteria

Children with milk protein allergies will be removed from the intervention group of Tooth mousse and continue with the control group

Outcome results