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

NCT03426150 | Completed Phase 4 DMC

• 1 other identifier: 20151225
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Erosion

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

CPP-ACP

EXPERIMENTAL

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

Drug: CPP-ACP

Deionized water

PLACEBO COMPARATOR

Deionized water application on the specimen surface for 3 min

Drug: Placebos

Interventions

CPP-ACP DRUG

The surfaces of specimens were pretreated with CPP-ACP for 3 min

CPP-ACP

Placebos DRUG

The surfaces of specimens were pretreated with deionized water for 3 min

Deionized water

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Related Publications (1)

• 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.

  PMID: 29857075 DERIVED

MeSH Terms

Conditions

Tooth Erosion

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Study Officials

• Hao Yu, DDS, PhD

  School and Hospital of Stomatology, Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 8, 2018
• Study Start: December 25, 2015
• Primary Completion: October 25, 2017
• Study Completion: February 5, 2018
• Last Updated: February 8, 2018

Record last verified: 2018-02