PersonalityNEOFFINCT02330614
Personality Bleaching
An observational study of Personality, run by University of Chile.
Trial summary
128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study. 58 patients were bleaching (experimental group) and 70 patients don't accepted the bleaching procedure (control group) were included in this study and signed a consent… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Personality
- What is being tested?
- Bleaching by peroxide carbamide 10%
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Dec 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study
Who may be able to join
- Participants included in this clinical trial were between 18 and 76 years old and had good general and oral health. Each subject had at least one central incisor with shade A2 or darker, assessed by comparison with a value-oriented shade guide (Vita classical, Vita Zahnfabrik, Bad Säckingen, Germany)
Who cannot join
- Participants that had undergone previous dental bleaching procedures during orthodontic treatment, or those that were pregnant or lactating women and participants with bruxism habits, were not included in the trial. Additionally, participants with restorations on the labial surfaces of their anterior teeth and non-carious cervical lesions, veneers or full crowns, with gingival recession, spontaneous tooth pain, internal tooth discoloration, and teeth with endodontic treatment or fluorosis were also excluded from this trial
About this study
Official title: Is the Personality Relevant in the Choice of Bleaching ?
128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study. 58 patients were bleaching (experimental group) and 70 patients don't accepted the bleaching procedure (control group) were included in this study and signed a consent form.Experimental group Patients who agreed to be bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject With verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications , before and after this procedure was applied again the NEO-FFI personality test form, had 30 minutes to answer it.Control group:Patients who refused to be bleached were administered the personality test NEO-FFI, had 30 minutes to answer it.
Read the detailed description
Data collection NEO-FFI data was collected in a Microsoft Excel data sheet and analyzed by a psychology that was blind to patient's expectations. According to the answers, each scale might get a score between 0 and 50.
Statistical analysis For comparisons between scales between groups of patients were bleaching and who refused to be bleached Mann Whitney test was used.For each pair of scales it was determined if any one of them predominated over its counterpart by Wilcoxon rank test before and after bleaching . To corroborate the statistical power of this study was calculated post-hoc with the NEO-FFI scores values between the comparisons and showed a high statistical power (0.99) by G-Power software.
- Conditions
- Personality
- Being tested
- Bleaching by peroxide carbamide 10%, Nothing - control group
- Keywords
- personality, bleaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleaching by peroxide carbamide 10%Other
bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject With verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications
Nothing - control groupOther
Only NEO-FFI test , data used as control
| Study group | Role | What they receive |
|---|---|---|
| bleaching patients | Patients who agreed to be bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject With verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications , before and after this procedure was applied again the NEO-FFI personality test form, had 30 minutes to answer it. Receives: Other: Bleaching by peroxide carbamide 10% | |
| Control group | Patients who refused to be bleached were administered the personality test NEO-FFI, had 30 minutes to answer it. Receives: Other: Nothing - control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEO-FFI score
Measured: Baseline / 1 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PersonalityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Fernandez, University of Chile
- Investigators
- eduardo fernandez, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330614
- Sponsor's protocol ID
- 2013-18
- Acronym
- NEOFFI
- Status last verified
- Dec 2014
- First submitted
- 27 Dec 2014
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Personality Relevant in the Choice of Bleaching ?
- ClinicalTrials.gov ID
- NCT02330614
- Acronym / sponsor ID
- NEOFFI / 2013-18
- Conditions
- Personality
- Keywords
- personality, bleaching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Jan 2015 (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.
128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study. 58 patients were bleaching (experimental group) and 70 patients don't accepted the bleaching procedure (control group) were included in this study and signed a consent form.Experimental group Patients who agreed to be bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject With verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications , before and after this procedure was applied again the NEO-FFI personality test form, had 30 minutes to answer it.Control group:Patients who refused to be bleached were administered the personality test NEO-FFI, had 30 minutes to answer it.
Detailed description
Data collection NEO-FFI data was collected in a Microsoft Excel data sheet and analyzed by a psychology that was blind to patient's expectations. According to the answers, each scale might get a score between 0 and 50.
Statistical analysis For comparisons between scales between groups of patients were bleaching and who refused to be bleached Mann Whitney test was used.For each pair of scales it was determined if any one of them predominated over its counterpart by Wilcoxon rank test before and after bleaching . To corroborate the statistical power of this study was calculated post-hoc with the NEO-FFI scores values between the comparisons and showed a high statistical power (0.99) by G-Power software.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bleaching patients | – | Other: Bleaching by peroxide carbamide 10%Patients who agreed to be bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject With verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications , before and after this procedure was applied again the NEO-FFI personality test form, had 30 minutes to answer it. |
| Control group | – | Other: Nothing - control groupPatients who refused to be bleached were administered the personality test NEO-FFI, had 30 minutes to answer it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study
Key inclusion criteria (1 listed)
- Participants included in this clinical trial were between 18 and 76 years old and had good general and oral health. Each subject had at least one central incisor with shade A2 or darker, assessed by comparison with a value-oriented shade guide (Vita classical, Vita Zahnfabrik, Bad Säckingen, Germany)
Key exclusion criteria (1 listed)
- Participants that had undergone previous dental bleaching procedures during orthodontic treatment, or those that were pregnant or lactating women and participants with bruxism habits, were not included in the trial. Additionally, participants with restorations on the labial surfaces of their anterior teeth and non-carious cervical lesions, veneers or full crowns, with gingival recession, spontaneous tooth pain, internal tooth discoloration, and teeth with endodontic treatment or fluorosis were also excluded from this trial
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 |
|---|---|---|
| Bleaching by peroxide carbamide 10%bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject With verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications | Other | bleaching patients |
| Nothing - control groupOnly NEO-FFI test , data used as control | Other | Control group |
Primary outcome
NEO-FFI score
Time frame: Baseline / 1 month after
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 5 Jan 2015.
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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.
eduardo fernandez principal investigator
University of Chile
Questions about this trial
What is this clinical trial studying?
An observational study of Personality, run by University of Chile.
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 1 inclusion and 1 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 5 Jan 2015. 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?
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?
NEO-FFI score (time frame: Baseline / 1 month after). 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 5 Jan 2015.