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

Tracking Information

First Received Date ^ICMJE

August 31, 2009

Last Updated Date

September 16, 2009

Start Date ^ICMJE

October 2008

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

colorimeter [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

colorimeter [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Tooth Whitening

Intervention ^ICMJE

Drug: Hydrogen Peroxide

Whitening product syringe type

Study Arm (s)

Experimental: whitening

30% Hydrogen peroxide

Intervention: Drug: Hydrogen Peroxide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00978861

Other Study ID Numbers ^ICMJE

RE5

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Je-Uk park / PI, The catholic university of korea seoul st. mary`s hospital

Study Sponsor ^ICMJE

JDC Tech

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Je-Uk Park, PI

The cathiloc university of korea seoul st. mary`s hospital

Information Provided By

JDC Tech

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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