Combination of Dental Bleaching Techniques, Randomized Clinical Trial

Sponsor

Universidad Iberoamericana (Other)

Overall Status

Completed

CT.gov ID

NCT02682329

Collaborator

(none)

120

Enrollment

Arms

17.9

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tooth Stain	Other: Hydrogen Peroxide and Carbamide Peroxide Other: Hydrogen Peroxide and Hydrogen Peroxide	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Combination of Dental Bleaching Techniques, Randomized Clinical Trial

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in color after the intervention [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universidad Iberoamericana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leandro Feliz, DDS, MEd, Universidad Iberoamericana

ClinicalTrials.gov Identifier:

NCT02682329

Other Study ID Numbers:

Dental Bleaching Techniques

First Posted:

Feb 15, 2016

Last Update Posted:

Feb 18, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Leandro Feliz, DDS, MEd, Universidad Iberoamericana

Peroxide

Additional relevant MeSH terms:

Tooth Discoloration

Hydrogen Peroxide

Carbamide Peroxide

Study Results

No Results Posted as of Feb 18, 2016