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

Phase 4

• Conditions: Tooth Bleaching; Quality of Life

• Registration Number: NCT03588871
• Lead Sponsor: Grupo de Investigação em Bioquímica e Biologia Oral

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-07-15
• Last Update Submitted: 2018-07-15
• Study First Posted: 2018-07-17
• Last Update Posted: 2018-07-17
• Primary Completion: 2019-05-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change on visually determination of tooth colour	2 weeks (before and after treatment)	Determination of tooth colour using a visual tooth shade guide
Change on spectrophotometer determination of tooth colour	2 weeks (before and after treatment)	Determination of tooth colour using a spectrophotometer
Subjective evaluation of tooth colour change during follow-up	1, 3 and 6 months	Determination of tooth colour relapse using visual tooth shade guide (VITA shade guide)
Change on quality of life during treatment and follow-up	2 weeks (before and after treatment), 1 month, 3 months and 6 months	Impact on quality of life using an oral quality of life measuring questionnaire, the Oral Health Impact Profile 14 (OHIP-14). The OHIP-14 ranges from 0 to 56 (final sum of all the seven subscales), with higher scores indicating poorer quality of life.
Objective evaluation of tooth colour change during follow-up	1, 3 and 6 months	Determination of tooth colour relapse using a spectrophotometer

Trial Locations

Locations (1)

Faculty of Dental Medicine of the University of Lisboa; 🇵🇹 Lisboa, Portugal