A clinical trial of a tooth cream in the repair of early dental decay.

A three-month, double-blind, parallel-group, placebo-controlled randomized clinical trial to investigate the remineralizing capacity of casein phosphopeptide-amorphous calcium phosphate in a post-orthodontic population.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000421437

Enrollment

Registered

2007-08-21

Start date

2006-08-01

Completion date

Unknown

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

Interventions

Tooth Mousse (containing casein phosphopeptide-amorphous calcium phosphate nanocomplexes (CPP-ACP). Tooth Mousse contains 10% w/v CPP-ACP. Dosage is 1ml Tooth Mousse twice daily for 12 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Healthy volunteers

Inclusion criteria

Undergoing fixed orthodontic treatment and due to have appliances removed during study period. Exhibiting a minimum of two WSLs on the buccal surfaces of teeth 14 to 44 (or 15 to 45 when first premolars have been extracted) at time of recruitment. Able to attend for four visits over a 12 week period.

Exclusion criteria

a.Allergies to milk proteins. b.Ulcerative mucosal conditions. c.Chronic use of medication causing xerostomia. d.Allergies to preservatives (or other ingredients) present in Tooth Mousse or placebo. e.Unrestored dentinal caries in teeth 14 to 44 (or 15 to 45). f.Pregnancy. g.Any other illnesses/conditions that the Investigator deems could affect the study outcome.

Outcome results