Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE (REMEWHITE)

Tracking Information
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; (submitted: September 16, 2009)	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; (submitted: September 16, 2009)	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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Tooth Whitening
Intervention ICMJE	Drug: Hydrogen Peroxide; Whitening product syringe type
Study Arms	Experimental: whitening; 30% Hydrogen peroxide; Intervention: Drug: Hydrogen Peroxide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 16, 2009)	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: 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
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Je-Uk Park, PI The cathiloc university of korea seoul st. mary`s hospital
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