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Combination of Dental Bleaching Techniques, Randomized Clinical Trial

Primary Purpose

Tooth Stain

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Hydrogen Peroxide and Carbamide Peroxide

Hydrogen Peroxide and Hydrogen Peroxide

About this trial

This is an interventional treatment trial for Tooth Stain focused on measuring Peroxide

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

CP 10% + HP 40%

CP 15% + HP 40%

CP 20% + HP 40%

HP 10% + HP 40%

Arm Description

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

Carbamide Peroxide 15% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office

Carbamide Peroxide 20% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT02682329

First Posted

February 3, 2016

Last Updated

February 17, 2016

Sponsor

Universidad Iberoamericana

1. Study Identification

Unique Protocol Identification Number

NCT02682329

Brief Title

Combination of Dental Bleaching Techniques, Randomized Clinical Trial

Official Title

Combination of Dental Bleaching Techniques, Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Iberoamericana

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Stain

Keywords

Peroxide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CP 10% + HP 40%

Arm Type

Active Comparator

Arm Description

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

Arm Title

CP 15% + HP 40%

Arm Type

Active Comparator

Arm Description

Carbamide Peroxide 15% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office

Arm Title

CP 20% + HP 40%

Arm Type

Active Comparator

Arm Description

Carbamide Peroxide 20% + Hydrogen Peroxide 40% were administered to each patient on this group.CP at home and HP at office

Arm Title

HP 10% + HP 40%

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Hydrogen Peroxide and Carbamide Peroxide

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Hydrogen Peroxide and Hydrogen Peroxide

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in color after the intervention

Description

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)

Time Frame

Two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25646134

Citation

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.

Results Reference

result

Learn more about this trial

Combination of Dental Bleaching Techniques, Randomized Clinical Trial

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