Comparison of the Efficacy and Quality of Life of Three Bleaching Products

NCT ID: NCT03588871

Last Updated: 2018-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-09-01

Brief Summary

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The aims of this study are: to compare the efficacy of three different dental bleaching products; to evaluate colour relapse following dental bleaching treatment at 1, 3 and 6 months follow up; to evaluate the impact in quality of life from dental bleaching treatments.

Products to be used represent three different techniques and formulations: in office, universal tray and custom tray (respectively VivaStyle Paint On Plus (Ivoclar Vivadent, Liechtenstein), Opalescence GO 6% (Ultradent, USA) and Opalescence PF 15% (Ultradent, USA).

All products contain 6% hydrogen peroxide or its equivalent.

Detailed Description

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Conditions

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Tooth Bleaching Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Dental bleaching with PaintOn Plus, HP 6%, 6x10min, two sessions

Group Type EXPERIMENTAL

Dental bleaching with PaintOn Plus VivaStyle

Intervention Type OTHER

Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent)

Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle

Intervention Type OTHER

Evaluation of oral quality of life after dental bleaching treatment with PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14

Group B

Dental bleaching with Opalescence GO, HP 6%, 10x60min

Group Type EXPERIMENTAL

Dental bleaching with Opalescence GO

Intervention Type OTHER

Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence GO 6% HP (Ultradent)

Dental Bleaching impact in quality of life with Opalescence GO

Intervention Type OTHER

Evaluation of oral quality of life after dental bleaching treatment with Opalescence GO 6% HP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14

Group C

Dental bleaching with Opalescence PF, CP 16%, 14x60h

Group Type EXPERIMENTAL

Dental bleaching with Opalescence PF

Intervention Type OTHER

Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence PF 16% CP (Ultradent)

Dental Bleaching impact in quality of life with Opalescence PF

Intervention Type OTHER

Evaluation of oral quality of life after dental bleaching treatment with Opalescence PF 16% CP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14

Interventions

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Dental bleaching with PaintOn Plus VivaStyle

Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent)

Intervention Type OTHER

Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle

Evaluation of oral quality of life after dental bleaching treatment with PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14

Intervention Type OTHER

Dental bleaching with Opalescence GO

Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence GO 6% HP (Ultradent)

Intervention Type OTHER

Dental Bleaching impact in quality of life with Opalescence GO

Evaluation of oral quality of life after dental bleaching treatment with Opalescence GO 6% HP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14

Intervention Type OTHER

Dental bleaching with Opalescence PF

Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence PF 16% CP (Ultradent)

Intervention Type OTHER

Dental Bleaching impact in quality of life with Opalescence PF

Evaluation of oral quality of life after dental bleaching treatment with Opalescence PF 16% CP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years old
* Be willing to refrain from use of tobacco products during the study
* Be willing to sign an informed consent form
* At least one teeth 13,11,21,23,33,43 has a gradable VITA shade A3,5 or darker by clinical assessment

Exclusion Criteria

* Teeht with restorations in frontal teeth
* Patients with untreated periodontitis or caries
* Patients with fixed orthodontics appliances
* Patients with know allergies to ingredients
* Patients who are nursing or pregnant
* Patients with severe systemic illnesses
* Patients with development tooth anomalies
* Patients with non vital anterior teeth
* Patients with insufficient oral hygiene
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ivoclar Vivadent AG

INDUSTRY

Sponsor Role collaborator

Grupo de Investigação em Bioquímica e Biologia Oral

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dental Medicine of the University of Lisboa

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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João Silveira, PhD, MSc

Role: CONTACT

+351966168040

Facility Contacts

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João Silveira, Phd, MSc

Role: primary

+351966168040

Other Identifiers

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BL16001

Identifier Type: -

Identifier Source: org_study_id

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