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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978861
First Posted: September 17, 2009
Last Update Posted: September 18, 2009
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.
Information provided by:
JDC Tech
August 31, 2009
September 17, 2009
September 18, 2009
October 2008
June 2009   (Final data collection date for primary outcome measure)
colorimeter [ Time Frame: 12 weeks after treatment ]
Same as current
No Changes Posted
colorimeter [ Time Frame: 24 weeks after treatment ]
Same as current
Not Provided
Not Provided
 
Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Tooth Whitening
Drug: Hydrogen Peroxide
Whitening product syringe type
Experimental: whitening
30% Hydrogen peroxide
Intervention: Drug: Hydrogen Peroxide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
August 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00978861
RE5
Yes
Not Provided
Not Provided
Je-Uk park / PI, The catholic university of korea seoul st. mary`s hospital
JDC Tech
Not Provided
Principal Investigator: Je-Uk Park, PI The cathiloc university of korea seoul st. mary`s hospital
JDC Tech
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP