Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE (REMEWHITE)
September 16, 2009 updated by: JDC Tech
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.
Study Overview
Detailed Description
This study intended to establish the efficacy of REMEWHITE after using the product under controlled conditions at the hospital.
The efficacy of the product was assessed at the end of the study; clinical examination by the dentist.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of
- The cathiloc university of korea seoul st. mary's hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ability to understand and provide informed consent
- general good health male and female adults, were 20 years or older
- no pregnant woman
- had six caines-free maxillary anterior teeth without restorations on the labial surfaces
Exclusion Criteria:
- had severe internal discoloration (tetracycline stains, fluorosis, pulpless teeth)
- evidence of fracture or major cracks on tooth
- were pregnant or nursing
- had tooth sensitivity
- smokers
- had teeth shade A1, A2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: whitening
30% Hydrogen peroxide
|
Whitening product syringe type
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
colorimeter
Time Frame: 12 weeks after treatment
|
12 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
colorimeter
Time Frame: 24 weeks after treatment
|
24 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Je-Uk Park, PI, The cathiloc university of korea seoul st. mary's hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
August 31, 2009
First Submitted That Met QC Criteria
September 16, 2009
First Posted (ESTIMATE)
September 17, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 17, 2009
Last Update Submitted That Met QC Criteria
September 16, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RE5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.