NCT02605239

Brief Summary

58 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study. Those patients were bleaching and included in this study and signed a consent form. The patients 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 OHIP-Esthetics , PIDAQ and OES questionnaire form, had 30 minutes to answer it, were completed before , immediately after and one month control post-bleaching procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

November 11, 2015

Last Update Submit

November 12, 2015

Conditions

Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

  • Oral Health and quality of Life

    Assesed by OHIP-Esthetics survey

    1 month

Secondary Outcomes (2)

  • phycosocial impact

    1 month

  • esthetics perception

    1 month

Study Arms (1)

bleaching teeth

EXPERIMENTAL

Group of patients will be bleaching with 10% peroxide carbamide , and them will be assessed the impact on dental confidence , impact psychosocial and esthetic perception

Drug: Bleaching teeth

Interventions

Bleaching teethDRUG

bleaching teeth with carbamide peroxide 10% for 3 weeks

Also known as: bleaching gel
bleaching teeth

Eligibility Criteria

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

You may qualify if:

  • Healthy patients with Anterior teeth without restorations, previous bleaching procedures, cervical lesions, or dental pain

You may not qualify if:

  • Pregnant or lactating,
  • Had moderate or severe fluorosis,
  • Tetracycline stains,
  • Orthodontic treatment,
  • Periodontal disease,
  • Orofacial tumors,
  • Trauma,
  • Tooth malformation Were taking analgesic, anti-inflammatory, or antibiotic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eduardo Fernandez Godoy

Santiago, 7500505, Chile

Location

Related Publications (2)

  • Martin J, Vildosola P, Bersezio C, Herrera A, Bortolatto J, Saad JR, Oliveira OB Jr, Fernandez E. Effectiveness of 6% hydrogen peroxide concentration for tooth bleaching-A double-blind, randomized clinical trial. J Dent. 2015 Aug;43(8):965-72. doi: 10.1016/j.jdent.2015.05.011. Epub 2015 Jun 6.

    PMID: 26057085BACKGROUND

  • Bersezio C, Martin J, Herrera A, Loguercio A, Fernandez E. The effects of at-home whitening on patients' oral health, psychology, and aesthetic perception. BMC Oral Health. 2018 Dec 11;18(1):208. doi: 10.1186/s12903-018-0668-2.

    PMID: 30537968DERIVED

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Tooth Bleaching

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Esthetics, DentalDentistry

Study Officials

  • eduardo fernandez

    University of Chile

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Eduardo Fernández

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 16, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

October 1, 2015

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

CL(1)