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

Study Overview
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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.

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

Conditions
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Tooth Bleaching, Quality of Life

Intervention / Treatment
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* Other: Dental bleaching with PaintOn Plus VivaStyle
* Other: Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle
* Other: Dental bleaching with Opalescence GO
* Other: Dental Bleaching impact in quality of life with Opalescence GO
* Other: Dental bleaching with Opalescence PF
* Other: Dental Bleaching impact in quality of life with Opalescence PF


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Dental bleaching with PaintOn Plus, HP 6%, 6x10min, two sessions | Other: Dental bleaching with PaintOn Plus VivaStyle<br>* Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent)<br>Other: Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle<br>* 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<br>|
| Experimental: Group B<br>Dental bleaching with Opalescence GO, HP 6%, 10x60min | Other: Dental bleaching with Opalescence GO<br>* Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence GO 6% HP (Ultradent)<br>Other: Dental Bleaching impact in quality of life with Opalescence GO<br>* 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<br>|
| Experimental: Group C<br>Dental bleaching with Opalescence PF, CP 16%, 14x60h | Other: Dental bleaching with Opalescence PF<br>* Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence PF 16% CP (Ultradent)<br>Other: Dental Bleaching impact in quality of life with Opalescence PF<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on visually determination of tooth colour | Determination of tooth colour using a visual tooth shade guide | 2 weeks (before and after treatment) | 
| Change on spectrophotometer determination of tooth colour | Determination of tooth colour using a spectrophotometer | 2 weeks (before and after treatment) | 
| Subjective evaluation of tooth colour change during follow-up | Determination of tooth colour relapse using visual tooth shade guide (VITA shade guide) | 1, 3 and 6 months | 
| Change on quality of life during treatment and follow-up | 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. | 2 weeks (before and after treatment), 1 month, 3 months and 6 months | 
| Objective evaluation of tooth colour change during follow-up | Determination of tooth colour relapse using a spectrophotometer | 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth bleaching, Quality of life