Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
REMEWHITE
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
1 other identifier
interventional
70
1 country
1
Brief Summary
The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 31, 2009
CompletedFirst Posted
Study publicly available on registry
September 17, 2009
CompletedSeptember 17, 2009
September 1, 2009
8 months
August 31, 2009
September 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
colorimeter
12 weeks after treatment
Secondary Outcomes (1)
colorimeter
24 weeks after treatment
Study Arms (1)
whitening
EXPERIMENTAL30% Hydrogen peroxide
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JDC Techlead
Study Sites (1)
The cathiloc university of korea seoul st. mary's hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Je-Uk Park, PI
The cathiloc university of korea seoul st. mary's hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 31, 2009
First Posted
September 17, 2009
Study Start
October 1, 2008
Primary Completion
June 1, 2009
Study Completion
August 1, 2009
Last Updated
September 17, 2009
Record last verified: 2009-09