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

NCT ID: NCT00978861

Last Updated: 2009-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tooth Whitening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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whitening

30% Hydrogen peroxide

Group Type EXPERIMENTAL

Hydrogen Peroxide

Intervention Type DRUG

Whitening product syringe type

Interventions

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Hydrogen Peroxide

Whitening product syringe type

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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JDC Tech

INDUSTRY

Sponsor Role lead

Responsible Party

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The catholic university of korea seoul st. mary's hospital

Principal Investigators

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Je-Uk Park, PI

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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RE5

Identifier Type: -

Identifier Source: org_study_id

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