CompletedPhase 3ACTRN12607000421437

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.


Sponsor

GC Corporation

Enrollment

46 participants

Start Date

Aug 1, 2006

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 12 YearssMax Age: 18 Yearss

Inclusion Criteria3

  • 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 Criteria7

  • 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.

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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.

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.


Locations(1)

Australia

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