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

Grupo de Investigação em Bioquímica e Biologia Oral

Status and phase: Unknown; Phase 4

Conditions: Quality of Life; Tooth Bleaching

Treatments: Other: Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle; Other: Dental bleaching with PaintOn Plus VivaStyle; Other: Dental bleaching with Opalescence PF; Other: Dental Bleaching impact in quality of life with Opalescence PF; Other: Dental Bleaching impact in quality of life with Opalescence GO; Other: Dental bleaching with Opalescence GO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03588871

BL16001

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

Other: Dental bleaching with PaintOn Plus VivaStyle

Other: Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle

Group B

Experimental group

Description:

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

Treatment:

Other: Dental bleaching with Opalescence GO

Other: Dental Bleaching impact in quality of life with Opalescence GO

Group C

Experimental group

Description:

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

Treatment:

Other: Dental Bleaching impact in quality of life with Opalescence PF

Other: Dental bleaching with Opalescence PF