Clinical Study to Evaluate of The Whitening Efficacy and... | NCT00978861

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

NCT00978861

Sponsor

JDC Tech

Status

Completed

Last Update Posted

Sep 17, 2009Estimated

Enrollment

70Actual

Phase

Phase 3

Conditions

Tooth Whitening

Interventions

Hydrogen Peroxide

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Aug 31, 2009

First Submission Date that Met QC Criteria

Sep 16, 2009

First Posted Date

Sep 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2009

Last Update Posted Date

Sep 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
whitening	Experimental	30% Hydrogen peroxide	Drug: Hydrogen Peroxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrogen Peroxide	Drug	Whitening product syringe type	whitening

Measure	Description	Time Frame
colorimeter		12 weeks after treatment

Measure	Description	Time Frame
colorimeter		24 weeks after treatment

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Je-Uk Park, PI	The cathiloc university of korea seoul st. mary's hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The cathiloc university of korea seoul st. mary's hospital		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D006861	Hydrogen Peroxide

Ancestor Terms

ID	Term
D010545	Peroxides
D010087	Oxides
D000838	Anions
D007477	Ions
D004573

Browse Leaves

Not provided

Browse Branches

Not provided