Casein Phosphopeptide--amorphous Calcium Phosphate on Human Enamel Subjected to in Vivo Acid Attacks

Fujian Medical University

Status and phase: Completed; Phase 4

Conditions: Dental Erosion

Treatments: Drug: CPP-ACP; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03426150

20151225

Details and patient eligibility

About

40 specimens were prepared from fresh-extracted human molars and further embedded using the acrylic resin. Specimens were randomly divided into 2 groups according to the treatment before in vivo erosion (n=20): CPP-ACP for 3 min (CPP-ACP group) and deionized water for 3 min (control group). 10 healthy volunteers were recruited and customized maxillary appliance containing 4 specimens (2 from CPP-ACP group and 2 from control group) was fabricated for each volunteer. Participants were instructed to drink 150 ml cola in 5 min using the gargling method after placing appliances intraorally for 2 h. The in vivo attacks were performed 4 X 5 min with 1-h interval daily over 7 d. The surface microhardness and surface microstructure of the specimens were evaluated at the baseline and after the treatment. The data were statistically analyzed using three-way ANOVA and post hoc tests. Data were considered statistically significant at a level of P <0.05.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 60 years of age and in good general health
• Dental erosion and wear degree is 0-1

Exclusion criteria

• Systemic diseases or oral mucosal disorders
• Current orthodontic treatment
• Pregnancy
• Known allergies to the experimental drink
• Had been given drugs which lead to dry oral more regularly within half a year

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

CPP-ACP

Experimental group

Description:

Tooth mousse (GC, Japan) application on the specimen surface for 3 min.

Treatment:

Drug: CPP-ACP

Deionized water

Placebo Comparator group

Description:

Deionized water application on the specimen surface for 3 min

Treatment:

Drug: Placebos