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)
View Full Details on ANZCTR
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ACTRN12607000421437