Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE (REMEWHITE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00978861 |
Recruitment Status
:
Completed
First Posted
: September 17, 2009
Last Update Posted
: September 17, 2009
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Sponsor:
JDC Tech
Information provided by:
JDC Tech
Tracking Information | ||||
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First Submitted Date ICMJE | August 31, 2009 | |||
First Posted Date ICMJE | September 17, 2009 | |||
Last Update Posted Date | September 17, 2009 | |||
Study Start Date ICMJE | October 2008 | |||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
colorimeter [ Time Frame: 12 weeks after treatment ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
colorimeter [ Time Frame: 24 weeks after treatment ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE | |||
Brief Summary | The purpose of this study is to determine the effect of REMEWHITE on tooth whitening. | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Tooth Whitening | |||
Intervention ICMJE | Drug: Hydrogen Peroxide
Whitening product syringe type |
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Study Arms | Experimental: whitening
30% Hydrogen peroxide
Intervention: Drug: Hydrogen Peroxide |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
70 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | August 2009 | |||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00978861 | |||
Other Study ID Numbers ICMJE | RE5 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Je-Uk park / PI, The catholic university of korea seoul st. mary`s hospital | |||
Study Sponsor ICMJE | JDC Tech | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | JDC Tech | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |