Tooth whitening effect of whitening patch with primer

Not Applicable

Completed

• Conditions: Tooth whitening; Oral Health

• Registration Number: ISRCTN63650330
• Lead Sponsor: Kyungpook National University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-10-31
• Study Start: 2020-08-20
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Adults over 20 years of age who agree to take the test
2. People with good general health and oral health
3. A person with six maxillary anterior teeth
4. A person with similar level of discoloration of each tooth showing proper tooth discoloration
5. A person who understands the purpose of the test and is able to read and write
6. Who can follow the test procedure and follow the visit schedule
7. Persons who can follow up during the test

Exclusion Criteria

1. People with inadequate dentition in the practice of tooth whitening
2. People with resin and porcelain restorations in the anterior region
3. A person who shows signs of inflammation in teeth due to dental caries or dental erosion
4. People with hypersensitivity due to gingivitis and periodontitis
5. People with excessive discolouration due to drugs and congenital anomalies
6. Those who have experienced tooth whitening in the past and have not passed 3 years
7. Women who are pregnant, breastfeeding or have a pregnancy plan during the test
8. Other diseases that may affect the efficacy and safety evaluation of the drug
9. A person who is taking or administering medication
10. People participating in other clinical trials or human attachment tests
11. Anyone who can not communicate or follow instructions
12. Those who do not qualify for the test under the judgment of the other examiners

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 09/10/2020:<br> Tooth color measured using ?L, ?a, ?b and ?E with Shade Eye NCC and Vita classical shade guide<br> at baseline, 3, 5, 7 and 10 days<br><br> _____<br><br> Previous primary outcome measure:<br><br> Tooth color measured using ?L, ?a, ?b with Shade Eye NCC and Vita classical shade guide at baseline, 3, 5, 7 and 10 days<br>

Secondary Outcome Measures

Name	Time	Method
Side effects measured using questionnaire, VAS scale and oral examination before patching and after 3, 5, 7 and 10 days