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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03588871
Enrollment
90
Registered
2018-07-17
Start date
2017-09-01
Completion date
2019-09-01
Last updated
2018-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Tooth Bleaching

Keywords

Tooth bleaching, Quality of life

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.

Interventions

OTHERDental 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)

OTHERDental 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

OTHERDental bleaching with Opalescence GO

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

OTHERDental 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

OTHERDental bleaching with Opalescence PF

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

OTHERDental 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

Sponsors

Ivoclar Vivadent AG
CollaboratorINDUSTRY
Grupo de Investigação em Bioquímica e Biologia Oral
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change on visually determination of tooth colour2 weeks (before and after treatment)Determination of tooth colour using a visual tooth shade guide
Change on spectrophotometer determination of tooth colour2 weeks (before and after treatment)Determination of tooth colour using a spectrophotometer
Subjective evaluation of tooth colour change during follow-up1, 3 and 6 monthsDetermination of tooth colour relapse using visual tooth shade guide (VITA shade guide)
Change on quality of life during treatment and follow-up2 weeks (before and after treatment), 1 month, 3 months and 6 monthsImpact 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-up1, 3 and 6 monthsDetermination of tooth colour relapse using a spectrophotometer

Countries

Portugal

Contacts

Primary ContactJoão Silveira, PhD, MSc
joao.silveira@campus.ul.pt+351966168040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026