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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Erosion
• Intervention / Treatment: Drug: CPP-ACP; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPP-ACP; Tooth mousse (GC, Japan) application on the specimen surface for 3 min.	Drug: CPP-ACP; The surfaces of specimens were pretreated with CPP-ACP for 3 min
Placebo Comparator: Deionized water; Deionized water application on the specimen surface for 3 min	Drug: Placebos; The surfaces of specimens were pretreated with deionized water for 3 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Hao Yu, DDS, PhD, School and Hospital of Stomatology, Fujian Medical University

Publications and helpful links

General Publications

• Yu H, Jiang NW, Ye XY, Zheng HY, Attin T, Cheng H. In situ effect of Tooth Mousse containing CPP-ACP on human enamel subjected to in vivo acid attacks. J Dent. 2018 Sep;76:40-45. doi: 10.1016/j.jdent.2018.05.021. Epub 2018 May 30.

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2015
• Primary Completion (Actual): October 25, 2017
• Study Completion (Actual): February 5, 2018

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Tooth Erosion
• Other Study ID Numbers: 20151225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No