NCT01959789

Brief Summary

The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

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

August 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

October 6, 2013

Last Update Submit

October 9, 2013

Conditions

Keywords

Randomized Controlled Clinical TrialTooth Bleaching

Outcome Measures

Primary Outcomes (1)

  • Tooth sensibility

    1 year

Secondary Outcomes (1)

  • Color

    1 year

Study Arms (2)

Control

Standard treatment

2 days

bleaching treatments made in 2 days

Eligibility Criteria

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

Participants included in this clinical trial were at least 18 years old and had good general and oral health. Participants were recruited by means of visual communication through posters in the university and in stores at Umuarama city. A total of 116 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria.

You may qualify if:

  • The participants should have:
  • At least six maxillary and mandibular anterior teeth caries-free. Without restorations on the labial surfaces. The central incisors should be C2 or darker according to a value-oriented shade guide (Vita Lumin).

You may not qualify if:

  • Pre-existing anterior restorations. Pregnant/lactating. Severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).
  • Taking any drug with anti-inflammatory and antioxidant action. Bruxism habits or any other pathology that could cause Tooth Sensbility (such as recession, dentine exposure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Paranaense - UNIPAR

Umuarama, Paraná, 87.502-210, Brazil

Location

Related Publications (1)

  • de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23.

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Eloisa A Paula, MD

    Universidade Estadual de Ponta Grossa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 10, 2013

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

August 1, 2012

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations