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

This study has been completed.
Information provided by:
JDC Tech Identifier:
First received: August 31, 2009
Last updated: September 16, 2009
Last verified: September 2009
The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.

Condition Intervention Phase
Tooth Whitening
Drug: Hydrogen Peroxide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by JDC Tech:

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

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

Enrollment: 70
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: whitening
30% Hydrogen peroxide
Drug: Hydrogen Peroxide
Whitening product syringe type

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.


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00978861

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

Responsible Party: Je-Uk park / PI, The catholic university of korea seoul st. mary`s hospital Identifier: NCT00978861     History of Changes
Other Study ID Numbers: RE5
Study First Received: August 31, 2009
Last Updated: September 16, 2009

Additional relevant MeSH terms:
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents processed this record on April 25, 2017