Tooth WhiteningPhase 3REMEWHITENCT00978861
Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
A Phase 3 study testing Hydrogen Peroxide in people with Tooth Whitening, run by JDC Tech at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the effect of REMEWHITE on tooth whitening. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Whitening
- What is being tested?
- Hydrogen Peroxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The cathiloc university of korea seoul st. mary's hospital
Seoul
About this study
Official title: A Randomized, Double-blind, Placebo-controlled 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.
Read the 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.
- Conditions
- Tooth Whitening
- Being tested
- Hydrogen Peroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen PeroxideDrug
Whitening product syringe type
| Study group | Role | What they receive |
|---|---|---|
| whitening | Experimental | 30% Hydrogen peroxide Receives: Drug: Hydrogen Peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
colorimeter
Measured: 12 weeks after treatment
Secondary outcomes (1)
colorimeter
Measured: 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WhiteningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- JDC Tech
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Je-Uk Park, PI, Principal investigator, The cathiloc university of korea seoul st. mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978861
- Sponsor's protocol ID
- RE5
- Acronym
- REMEWHITE
- Status last verified
- Sep 2009
- First submitted
- 31 Aug 2009
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
- ClinicalTrials.gov ID
- NCT00978861
- Acronym / sponsor ID
- REMEWHITE / RE5
- Conditions
- Tooth Whitening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- JDC TechIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| whitening | Experimental | Drug: Hydrogen Peroxide30% Hydrogen peroxide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen PeroxideWhitening product syringe type | Drug | whitening |
Primary outcome
colorimeter
Time frame: 12 weeks after treatment
1 secondary outcome
colorimeter
Time frame: 24 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Je-Uk Park, PI principal investigator
The cathiloc university of korea seoul st. mary's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrogen Peroxide in people with Tooth Whitening, run by JDC Tech at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colorimeter (time frame: 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2009.