NCT02682329

Brief Summary

To determine the effectiveness of combining different concentrations of hydrogen peroxide and carbamide used during tooth bleaching.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

February 3, 2016

Last Update Submit

February 17, 2016

Conditions

Keywords

Peroxide

Outcome Measures

Primary Outcomes (1)

  • Change in color after the intervention

    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

Study Arms (4)

CP 10% + HP 40%

ACTIVE COMPARATOR

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

CP 15% + HP 40%

ACTIVE COMPARATOR

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

CP 20% + HP 40%

ACTIVE COMPARATOR

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

HP 10% + HP 40%

ACTIVE COMPARATOR

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

Interventions

Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office

CP 10% + HP 40%CP 15% + HP 40%CP 20% + HP 40%

Hydrogen Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP at home and HP at office

HP 10% + HP 40%

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Feliz-Matos L, Hernandez LM, Abreu N. Dental Bleaching Techniques; Hydrogen-carbamide Peroxides and Light Sources for Activation, an Update. Mini Review Article. Open Dent J. 2015 Jan 6;8:264-8. doi: 10.2174/1874210601408010264. eCollection 2014.

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Hydrogen PeroxideCarbamide Peroxide

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic ChemicalsUreaAmides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MEd

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 15, 2016

Study Start

February 1, 2014

Primary Completion

January 1, 2015

Study Completion

August 1, 2015

Last Updated

February 18, 2016

Record last verified: 2016-02