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

This study has been completed.
Sponsor:
Information provided by:
JDC Tech
ClinicalTrials.gov Identifier:
NCT00978861
First received: August 31, 2009
Last updated: September 16, 2009
Last verified: September 2009

August 31, 2009
September 16, 2009
October 2008
June 2009   (final data collection date for primary outcome measure)
colorimeter [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00978861 on ClinicalTrials.gov Archive Site
colorimeter [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00978861
RE5
Yes
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