NCT00978861CompletedPhase 3
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
JDC Tech1 site in 1 country70 target enrollmentStarted: October 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- colorimeter
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •had teeth shade A1, A2
Arms & Interventions
whitening
Experimental
30% Hydrogen peroxide
Intervention: Hydrogen Peroxide (Drug)
Outcomes
Primary Outcomes
colorimeter
Time Frame: 12 weeks after treatment
Secondary Outcomes
- colorimeter(24 weeks after treatment)
Investigators
Study Sites (1)
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