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

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ClinicalTrials.gov Identifier: NCT00978861
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : September 17, 2009
Sponsor:
Information provided by:
JDC Tech

Brief Summary:
The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.

Condition or disease Intervention/treatment Phase
Tooth Whitening Drug: Hydrogen Peroxide Phase 3

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  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
Study Start Date : October 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: whitening
30% Hydrogen peroxide
Drug: Hydrogen Peroxide
Whitening product syringe type



Primary Outcome Measures :
  1. colorimeter [ Time Frame: 12 weeks after treatment ]

Secondary Outcome Measures :
  1. colorimeter [ Time Frame: 24 weeks after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978861


Locations
Korea, Republic of
The cathiloc university of korea seoul st. mary`s hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JDC Tech
Investigators
Principal Investigator: Je-Uk Park, PI The cathiloc university of korea seoul st. mary`s hospital

Responsible Party: Je-Uk park / PI, The catholic university of korea seoul st. mary`s hospital
ClinicalTrials.gov Identifier: NCT00978861     History of Changes
Other Study ID Numbers: RE5
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents