search
Back to results

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

Primary Purpose

Dental Erosion

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
CPP-ACP
Placebos
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Erosion

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CPP-ACP

    Deionized water

    Arm Description

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

    Deionized water application on the specimen surface for 3 min

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 24, 2018
    Last Updated
    February 6, 2018
    Sponsor
    Fujian Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03426150
    Brief Title
    Casein Phosphopeptide--amorphous Calcium Phosphate on Human Enamel Subjected to in Vivo Acid Attacks
    Official Title
    In Situ Effect of Casein Phosphopeptide--amorphous Calcium Phosphate on the Surface Microhardness of Human Enamel Subjected to in Vivo Acid Attacks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 25, 2015 (Actual)
    Primary Completion Date
    October 25, 2017 (Actual)
    Study Completion Date
    February 5, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fujian Medical University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Erosion

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CPP-ACP
    Arm Type
    Experimental
    Arm Description
    Tooth mousse (GC, Japan) application on the specimen surface for 3 min.
    Arm Title
    Deionized water
    Arm Type
    Placebo Comparator
    Arm Description
    Deionized water application on the specimen surface for 3 min
    Intervention Type
    Drug
    Intervention Name(s)
    CPP-ACP
    Intervention Description
    The surfaces of specimens were pretreated with CPP-ACP for 3 min
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    The surfaces of specimens were pretreated with deionized water for 3 min
    Primary Outcome Measure Information:
    Title
    Surface microhardness
    Description
    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.
    Time Frame
    baseline
    Title
    Surface microhardness
    Description
    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.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hao Yu, DDS, PhD
    Organizational Affiliation
    School and Hospital of Stomatology, Fujian Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29857075
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs