Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE - Full Text View

Sponsor:	JDC Tech
Information provided by:	JDC Tech
ClinicalTrials.gov Identifier:	NCT00978861

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 III

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:

Drug Information available for: Hydrogen peroxide

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

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 February 21, 2012