Comparison of the Efficacy and Quality of Life of Three Bleaching Products
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJuly 17, 2018
May 1, 2018
1.7 years
May 4, 2018
July 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (3)
Group A
EXPERIMENTALDental bleaching with PaintOn Plus, HP 6%, 6x10min, two sessions
Group B
EXPERIMENTALDental bleaching with Opalescence GO, HP 6%, 10x60min
Group C
EXPERIMENTALDental bleaching with Opalescence PF, CP 16%, 14x60h
Interventions
Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent)
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
Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence GO 6% HP (Ultradent)
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
Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence PF 16% CP (Ultradent)
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dental Medicine of the University of Lisboa
Lisbon, Portugal
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2018
First Posted
July 17, 2018
Study Start
September 1, 2017
Primary Completion
May 1, 2019
Study Completion
September 1, 2019
Last Updated
July 17, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share