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
CRIS Registration Number |
KCT0004625 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | LG Household & Health Care |
Organization Type | Research Institute |
Project ID | P201702-0000017 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyungpook National University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2020. 12 |
Way of Sharing | To be made available at a later date
(jkk0621@dhc.ac.kr) |
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