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Completed

NCT Number: NCT00978861

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

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

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Key information

Conditions

Tooth Whitening

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrogen Peroxide

Drug

Whitening product syringe type

Primary outcomes

  1. colorimeter

    Time frame: 12 weeks after treatment

Secondary outcomes

  1. colorimeter

    Time frame: 24 weeks after treatment

Sponsors and collaborators

Lead sponsor

JDC Tech

Industry

Registry information

Official study title

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

Acronym: REMEWHITE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 17, 2009
Registry last updated
Sep 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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