Combination of Dental Bleaching Techniques, Randomized Clinical Trial

February 17, 2016 updated by: Leandro Feliz, Universidad Iberoamericana
To determine the effectiveness of combining different concentrations of hydrogen peroxide and carbamide used during tooth bleaching.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

120 patiens over 18 years old.

Design:

Hydrogen peroxide (HP) Carbamide Peroxide (CP)

Group 1: CP 10% + HP 40% Group 2: CP 15% + HP 40% Group 3: CP 20% + HP 40% Group 4: HP 10% + HP 40%

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 45 years old
  • Student, teacher or administrative personnel at UNIBE.

Exclusion Criteria:

  • Dental Hypersensitivity
  • Periodontal disease
  • Active caries lesions
  • Allergy to latex
  • Orthodontic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CP 10% + HP 40%
Carbamide Peroxide 10% + Hydrogen Peroxide 40% were administered to each patient on this group. CP at home and HP at office
Other: Hydrogen Peroxide and Carbamide Peroxide
Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office
ACTIVE_COMPARATOR: CP 15% + HP 40%
Carbamide Peroxide 15% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office
Other: Hydrogen Peroxide and Carbamide Peroxide
Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office
ACTIVE_COMPARATOR: CP 20% + HP 40%
Carbamide Peroxide 20% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office
Other: Hydrogen Peroxide and Carbamide Peroxide
Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office
ACTIVE_COMPARATOR: HP 10% + HP 40%
Hydrogen Peroxide 10% + Hydrogen Peroxide 40% were administered to each patient on this group. HP at Home and HP at office
Other: Hydrogen Peroxide and Hydrogen Peroxide
Hydrogen Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP at home and HP at office

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in color after the intervention
Time Frame: Two weeks
The color was taken with conventional hade guide VITA by human observation, with the color range from A to D, each color range with 5 classifications. (Ej. A1, A2, A3, A4, A5)
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Iberoamericana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (ESTIMATE)

February 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dental Bleaching Techniques

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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