NCT02330614

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
Last Updated

January 5, 2015

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

December 27, 2014

Last Update Submit

December 31, 2014

Conditions

Keywords

personalitybleaching

Outcome Measures

Primary Outcomes (1)

  • NEO-FFI score

    Baseline / 1 month after

Study Arms (2)

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.

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.

Other: Nothing - control group

Interventions

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

bleaching patients

Only NEO-FFI test , data used as control

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • eduardo fernandez

    University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Eduardo Fernández G.

Study Record Dates

First Submitted

December 27, 2014

First Posted

January 5, 2015

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

January 5, 2015

Record last verified: 2014-12