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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by JDC Tech:

Primary Outcome Measures:
  • colorimeter [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • colorimeter [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 31, 2009
Last Updated: September 16, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013