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Clinical Efficacy of Self-Bleaching Agent Combining Primer and Patch

Status Approved

  • First Submitted Date

    2019/12/05

  • Registered Date

    2020/01/14

  • Last Updated Date

    2020/01/03

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004625
    Unique Protocol ID KNU 2019-0009
    Public/Brief Title Study on the efficacy of whitening agent that combines protective and whitening agent
    Scientific Title Clinical Efficacy of Self-Bleaching Agent Combining Primer and Patch
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KNU 2019-0009
    Approval Date 2019-03-04
    Institutional Review Board Name Kyungpook National University Industry Foundation
    Institutional Review Board Address Institutional Review Board of Kyungpook National University, 80, Daehak-ro, Buk-gu, Daegu
    Institutional Review Board Telephone 053-950-2353
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Song Keun Bae
    Title Professor
    Telephone +82-53-660-6870
    Affiliation Kyungpook National University
    Address Department of Preventive Dentistry School of Dentistry, Kyungpook National University 2177 Dalgubeol-daero, Jung-gu daegu 700-412, Korea
    Contact Person for Public Queries
    Name Kim Jin Kyoung
    Title Reseacher
    Telephone +82-53-660-6870
    Affiliation Kyungpook National University
    Address Department of Preventive Dentistry School of Dentistry, Kyungpook National University 2177 Dalgubeol-daero, Jung-gu daegu 700-412, Korea
    Contact Person for Updating Information
    Name Kim Jin Kyoung
    Title Reseacher
    Telephone +82-53-660-6870
    Affiliation Kyungpook National University
    Address Department of Preventive Dentistry School of Dentistry, Kyungpook National University 2177 Dalgubeol-daero, Jung-gu daegu 700-412, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-03-04 Actual
    Target Number of Participant 112
    Primary Completion Date 2019-04-08 , Actual
    Study Completion Date 2019-04-08 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Kyungpook National University
    Recruitment Status Completed
    Date of First Enrollment 2019-03-04 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name LG Household & Health Care
    Organization Type Research Institute
    Project ID P201702-0000017
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kyungpook National University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    As part of dental cosmetology, social interests and desires for whitening teeth, which brightens the color tone of teeth, have increased. It is the whitening treatment that returns the color of the colored tooth to the original tooth color or makes it brighter than before, due to external or internal causes, and the whitening is the most conservative and popular treatment for discolored teeth without elimination of hemorrhoids. It became a cure. In response, various types of tooth whitening products have been competitively developed in many countries.
      Self-whitening products include whitening toothpaste, pre-loaded tray whitening products and whitening patches. Among them, the patch for whitening is a medium for applying peroxide, which is a whitening component, to the tooth surface.The patch is shorter in application time and has less loss of whitening components and is easier to use than a conventional tray type product containing a gel type whitening agent. . In addition, while using a low concentration of the peroxide has been reported to have a satisfactory whitening effect and little side effects. However, in Korea, according to the recommendations of the KFDA, whitening agents containing more than 3% of peroxide cannot be used. Patch products used before have a relatively long application time and are cumbersome when removing patches.
      Taurine is a free amino acid in the body, and it is known to have a calcium regulating ability to increase its availability under conditions of low calcium availability in the body. I confirmed it. These perceptual mitigating ingredients can help to prevent side effects such as hypersensitivity that can occur during whitening treatment.   Therefore, in this study, we compared the whitening effect according to application time for 30 minutes and 60 minutes of attachment of taurine-containing primer and 3.0% peroxide self-whitening patch to prevent hypersensitivity of hard and soft tissues. The purpose of this study is to investigate the inconvenience and side effects of patch attachment and removal.
      1) When a whitening patch containing 3.0% peroxide is applied for a minimum of 30 minutes and a maximum of 60 minutes, it confirms the effectiveness of whitening compared to the placebo control group, and confirms the difference according to the application time of 30 minutes and 60 minutes.2) After applying taurine-containing primers, the clinical safety was checked by examining the side effects of whitening through self-introduction questionnaire asking the patient's subjective symptoms and oral examination by the dentist. Check for differences.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Factorial  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    - Drugs: hydrogen peroxide
    - Capacity: 3.0%
    - Number of times: once / day
    - Duration: 10 days
    - Injection route: Remove the patch containing the chemicals on the tooth surface
    - 30 minutes placebo control group, 30 minutes experiment group, 60 minutes placebo control group, 60 minutes experiment group
    - 30 minute group (placebo control group, experimental group): Remove the patch containing the drug once per day for 30 minutes
    - 60 minutes group (placebo control group, experimental group): Remove the patch containing the drug once per day for 60 minutes and remove it
    Number of Arms 4
    Arm 1

    Arm Label

    30 min placebo control group

    Target Number of Participant

    25

    Arm Type

    Placebo comparator

    Arm Description

    - Drugs: Placebo
    - Number of times: once / day
    - Duration: 30min /10 days
    - Injection route: Remove patch after attaching patch that doesn't contain the drug
    Arm 2

    Arm Label

    30 min experiment group

    Target Number of Participant

    25

    Arm Type

    Experimental

    Arm Description

    - Drugs: hydrogen peroxide
    - Capacity: 3.0%
    - Number of times: once / day
    - Duration: 30 min / 10 days
    - Injection route: After applying taurine, attach the patch containing the relevant chemical to the tooth surface and remove
    Arm 3

    Arm Label

    60 min placebo control group

    Target Number of Participant

    25

    Arm Type

    Placebo comparator

    Arm Description

    - Drugs: Placebo
    - Number of times: once / day
    - Duration: 60min /10 days
    - Injection route: Remove patch after attaching patch that doesn't contain the drug
    Arm 4

    Arm Label

    60 min experiment group

    Target Number of Participant

    25

    Arm Type

    Experimental

    Arm Description

    - Drugs: hydrogen peroxide
    - Capacity: 3.0%
    - Number of times: once / day
    - Duration: 60 min / 10 days
    - Injection route: After applying taurine, attach the patch containing the relevant chemical to the tooth surface and remove
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (K00-K93)Diseases of the digestive system 
       (K03.6)Deposits[accretions] on teeth 

    Those who want to change the color of teeth brightly and have no oral or systemic diseases
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~60Year

    Description

    * Inclusion *
    - Adults over 20 years of age who agree to participate in the test
    - Have good general health and oral health
    - Person with six maxillary anterior teeth
    - People who have a proper level of discoloration of teeth and similar degree of discoloration of each tooth
    - A person who understands the purpose of the test and who can read and write
    - A person who can follow the test procedure well and follow the visit schedule
    - Who can be followed during the test
    Exclusion Criteria
    * Exclusion *
    - People with inadequate dentition in the practice of teeth whitening
    - Resin and porcelain restoration in the anterior region
    - Inflammation of the pulp due to dental caries or tooth abrasion
    - People with hypersensitivity due to gingivitis and periodontitis
    - People with excessive discoloration due to medication and birth defects
    - Haven't had teeth whitening in the past 3 years
    - Women who are pregnant, lactating or planning pregnancy during the trial
    - There are other diseases or administration of the drug that may affect the efficacy or safety evaluation of the drug
    - Participants in other clinical or human trials
    - Others unable to communicate or have difficulty following instructions
    - Others who are not suitable for the examination under the judgment of the person in charge of the examination
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Efficacy - delta L, a, b, E
    Timepoint
    Before the procedure, aftrer the procedure 3 days, 5 days, 7 days, 10 days
    Primary Outcome(s) 2
    Outcome
    Efficacy - National Bureau of Standards (NBS) unit
    Timepoint
    Before the procedure, aftrer the procedure 3 days, 5 days, 7 days, 10 days
    Secondary Outcome(s) 1
    Outcome
    Safety - Gingival index, tooth sensitivity, gingival irritation
    Timepoint
    Before the procedure, aftrer the procedure 3 days, 5 days, 7 days, 10 days
    Secondary Outcome(s) 2
    Outcome
    Safety - Tooth sensitivity
    Timepoint
    Before the procedure, aftrer the procedure 3 days, 5 days, 7 days, 10 days
    Secondary Outcome(s) 3
    Outcome
    Safety - Gingival irritation
    Timepoint
    Before the procedure, aftrer the procedure 3 days, 5 days, 7 days, 10 days
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2020. 12
    Way of Sharing To be made available at a later date
    (jkk0621@dhc.ac.kr)
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