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

Dental Erosion Clinical Trial

Official title:

In Situ Effect of Casein Phosphopeptide--amorphous Calcium Phosphate on the Surface Microhardness of Human Enamel Subjected to in Vivo Acid Attacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426150
• Other study ID #: 20151225
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2018
• Last updated: February 6, 2018
• Start date: December 25, 2015
• Est. completion date: February 5, 2018

Study information

• Verified date: February 2018
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 5, 2018
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Erosion
• Tooth Erosion

Intervention

Drug:
• CPP-ACP
The surfaces of specimens were pretreated with CPP-ACP for 3 min
• Placebos
The surfaces of specimens were pretreated with deionized water for 3 min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surface microhardness	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.	baseline
Primary	Surface microhardness	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.	7 days