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Preventive Strategies for Early Childhood Caries (ECC) from Antenatal to age 24 months

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000356561
Enrollment
1017
Registered
2006-08-18
Start date
2007-01-12
Completion date
2008-06-30
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

This project aims to determine the best preventive methods for ECC by assessing variations of strategies. The strategies that will be used are • Education classes to antenatal and new parent groups • Preventive agents – participants will be randomly assigned to the following groups: toothbrushing with low-dose fluoride toothpaste, toothbrushing with 0.2 percent chlorhexidine gel, and toothbrushing with casein-phosphoprotein gel (CPP-ACP, Tooth Mousse) • Support through home visits and phone calls The effectiveness of these strategies will be assessed through • Pre and post questionnaires including dental knowledge, feeding practices and oral hygiene practices • Microbial analysis for the presence of decay-causing bacteria (blinded) • Dental screen analysis of participants having home visits (calibrated operators, not blinded) • Dental screen analysis at the 2 year recall (blinded) • Statistical analysis of data for case and control groups Participants will be recruited either from antenatal classes, pre-registration for maternity ward or new parent classes. All participants will be recalled when their child is approximately 6-9 months, 9-12 months and 15-18 months either through the home visit or by telephone. All will be asked to attend an appointment at the 24-26 month recall with their child. Swab samples of the teeth and gums will be taken and tested for the presence of decay-causing bacteria (mutans streptococci) and general oral bacteria in which participants will be informed of the results. The Mother’s teeth will be wiped with sterile cotton-tipped swabs at the initial contact, when the child is born and at the final recall. Those who wish to participate in home visits will also have their teeth swabbed at the 6-9 month period and their child’s teeth will be swabbed when their child is 6-9 months, 9-12 months and 15-18 months. Resources such as toothbrushes and preventive products will be supplied free of charge for the duration of participation or until the child is 24-26 months.

Interventions

Toothbrushing daily only with low dose fluoride toothpaste or in combination with either Casein Phosphopeptide – Amorphous Calcium Phosphate (Tooth Mousse) or 0.2% Chlorhexidine toothpaste from eruption of first tooth until child is 24 months of age.

Sponsors

Oral Health Program, Logan-Beaudesert Health Service District, Queensland Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Pregnant women and new mothers in the Logan-Beaudesert Health Service District.

Exclusion criteria

Children with milk protein allergies (due to reaction to preventive agent to be used).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026