A controlled trial of Casein Phosphopeptide - Amorphous Calcium Phosphate (CPP-ACP) toothpaste in 6 year old children

A randomised double blind study to evaluate the effectiveness of a CPP-ACP toothpaste to prevent carious lesions in at-risk six year old children.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001227583

Enrollment

210

Registered

2015-11-10

Start date

2016-04-11

Completion date

2018-03-31

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 study aims to determine - the effectiveness of using a CPP-ACP toothpaste in preventing dental caries in children - the microbial changes in plaque such as the reduction in decay causing bacteria Participants will attend routine dental examination appointments at public oral health services. In addition to standard examination a sample of plaque will be taken by swabbing selected teeth with a small brush. A questionnaire will be completed by the participant's parents regarding medical, social, toothbrushing and dietary histories. Dental radiographs will be taken at the recruitment appointment. All identified treatment will be undertaken. At the first appointment, a participant's toothbrushing group will be randomly allocated. The allocation is either the CPP-ACP toothpaste or the placebo toothpaste (blinded groups) or commercial fluoridated toothpaste (non blinded). For the blinded groups (CPP-ACP and placebo), the toothpaste packaging will be marked with a digital code, but the content will not be known to the participants, the clinicians or the investigator. The codes will be provided to the chief supervisor of the study. Only after the statistical evaluation is completed will the decoding occur. All the toothbrushes and toothpaste will be provided free of charge for the duration of the study. Participants are asked to brush twice daily will the allocated toothpaste. Compliance will be monitored by a phone call questionnaire at 3 and 9 months and in person at 6 and 12 month . The examination appointment will be repeated at 6 months and 12 months. Dental radiographs will be taken at 12 months.

Interventions

Toothbrushing twice daily with a smear amount of CPP-ACP toothpaste for 12 months. At three monthly intervals, participants will be questioned on their product use/ adherence to the intervention and asked about their product supply needs.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

5 Years to 7 Years

Healthy volunteers

Yes

Inclusion criteria

One or more partially erupted/ erupted first molars One or more DMFT/ dmft according to the WHO criteria

Exclusion criteria

- Children with a milk protein allergy - Children with a benzoate sensitivity - Children who are participating or have participated in the previous two years to other intervention studies - Children using topical antimicrobials (except for fluoridated toothpaste) - Children who have had systemic antibiotics use in the three months prior to baseline - Children who reside in areas that have a non-fluoridated water supply - Children who do not complete baseline treatment within 8 weeks - Edentulous or children with less than 4 teeth - Children with fixed or removable orthodontic appliances for cleft lip and palate - Children with severe facial trauma

Outcome results