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

Phase 4

Completed

• Conditions: Dental Erosion
• Interventions: Drug: Placebos; Drug: CPP-ACP

• Registration Number: NCT03426150
• Lead Sponsor: Fujian Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-25
• Primary Completion: 2017-10-25
• Study First Submitted: 2018-01-24
• Status Verified: 2018-02
• Study Completion: 2018-02-05
• Study First Submitted QC: 2018-02-06
• Last Update Submitted: 2018-02-06
• Study First Posted: 2018-02-08
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Deionized water	Placebos	Deionized water application on the specimen surface for 3 min
CPP-ACP	CPP-ACP	Tooth mousse (GC, Japan) application on the specimen surface for 3 min.

Primary Outcome Measures

Name	Time	Method
Surface microhardness	7 days	a Vickers microhardness tester with microscopic lens was used, with a 100 g load and 30-s dwell time. Three microhardness measurements were obtained on the top surface of each specimen.