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

Phase 3

Completed

• Conditions: Tooth Whitening
• Interventions: Drug: Hydrogen Peroxide

• Registration Number: NCT00978861
• Lead Sponsor: JDC Tech

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Study First Submitted: 2009-08-31
• Status Verified: 2009-09
• Study First Submitted QC: 2009-09-16
• Last Update Submitted: 2009-09-16
• Study First Posted: 2009-09-17
• Last Update Posted: 2009-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
whitening	Hydrogen Peroxide	30% Hydrogen peroxide

Primary Outcome Measures

Name	Time	Method
colorimeter	12 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
colorimeter	24 weeks after treatment

Trial Locations

Locations (1)

The cathiloc university of korea seoul st. mary's hospital; 🇰🇷 Seoul, Korea, Republic of