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

Tooth Whitening Clinical Trial

— REMEWHITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978861
• Other study ID #: RE5
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2009
• Last updated: September 16, 2009
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: JDC Tech
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tooth Whitening

Intervention

Drug:
• Hydrogen Peroxide
Whitening product syringe type

Locations

Country	Name	City	State
Korea, Republic of	The cathiloc university of korea seoul st. mary`s hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JDC Tech

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colorimeter		12 weeks after treatment	No
Secondary	colorimeter		24 weeks after treatment	No