Bleaching; SatisfactoryNCT03153605
The Correlation and Relationship Between Chromaticity Parameters and Treatment Satisfaction Before and After Tooth Bleaching
A study testing Common toothpaste in people with Bleaching; Satisfactory, run by Fujian Medical University.
Trial summary
Explore the correlation and specific relationship between chromaticity parameters and treatment satisfaction before and after tooth bleaching, compare the curative effect of different tooth bleaching programs. Read more about this study
- Who is it for?
- Ages 20 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Bleaching; Satisfactory
- What is being tested?
- Common toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to 9 Dec 2017
- Phase
- Interventional
- 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 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age around 20~28 years,
- at least six anterior teeth without restorations,
- good general and oral health (no dental caries and periodontal disease).
Who cannot join
- tooth sensitivity,
- any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure),
- participants under orthodontic treatment,
- smokers.
About this study
Explore the correlation and specific relationship between chromaticity parameters and treatment satisfaction before and after tooth bleaching, compare the curative effect of different tooth bleaching programs.
- Conditions
- Bleaching; Satisfactory
- Being tested
- Common toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common toothpasteOther
different toothpaste
| Study group | Role | What they receive |
|---|---|---|
| SATISI_7 | Experimental | Not described Receives: Other: Common toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of tooth color
The certain points of tooth color
Measured: baseline, 7 days after treatment, 14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study startApr 2016
- Primary completion9 Oct 2017 (estimated)
- Study completion9 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleaching; SatisfactoryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Yu, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153605
- Sponsor's protocol ID
- 201502311
- Status last verified
- May 2017
- First submitted
- 24 Apr 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation and Relationship Between Chromaticity Parameters and Treatment Satisfaction Before and After Tooth Bleaching
- ClinicalTrials.gov ID
- NCT03153605
- Acronym / sponsor ID
- 201502311
- Conditions
- Bleaching; Satisfactory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 9 Oct 2017 (estimated)
- Study completion
- 9 Dec 2017 (estimated)
- First posted
- 15 May 2017 (actual)
- 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.
Explore the correlation and specific relationship between chromaticity parameters and treatment satisfaction before and after tooth bleaching, compare the curative effect of different tooth bleaching programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SATISI_7 | Experimental | Other: Common toothpaste |
Who may qualify
- Ages
- 20 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age around 20~28 years,
- at least six anterior teeth without restorations,
- good general and oral health (no dental caries and periodontal disease).
Key exclusion criteria (4 listed)
- tooth sensitivity,
- any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure),
- participants under orthodontic treatment,
- 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 |
|---|---|---|
| Common toothpastedifferent toothpaste | Other | SATISI_7 |
Primary outcome
Changes of tooth color
Time frame: baseline, 7 days after treatment, 14 days after treatment
The certain points of tooth color
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Bleaching; Satisfactory
Enrolling by invitation
Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction
Bleaching; Satisfactory, Bleaching Sensitivity
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Common toothpaste in people with Bleaching; Satisfactory, run by Fujian Medical University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Changes of tooth color (time frame: baseline, 7 days after treatment, 14 days 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 29 Sep 2017.