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

July 15, 2018 updated by: Grupo de Investigação em Bioquímica e Biologia Oral

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Lisboa, Portugal
        • Recruiting
        • Faculty of Dental Medicine of the University of Lisboa
        • Contact:
        • Principal Investigator:
          • António Mata, PhD, MSc
        • Sub-Investigator:
          • Duarte Marques, PhD, MSc
        • Sub-Investigator:
          • João Silveira, PhD, MSc
        • Sub-Investigator:
          • Ruben Pereira, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Dental bleaching with PaintOn Plus, HP 6%, 6x10min, two sessions
Other: Dental 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)
Other: Dental 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
Experimental: Group B
Dental bleaching with Opalescence GO, HP 6%, 10x60min
Other: Dental bleaching with Opalescence GO
Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence GO 6% HP (Ultradent)
Other: Dental 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
Experimental: Group C
Dental bleaching with Opalescence PF, CP 16%, 14x60h
Other: Dental bleaching with Opalescence PF
Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence PF 16% CP (Ultradent)
Other: Dental 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigação em Bioquímica e Biologia Oral

Collaborators

Ivoclar Vivadent AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

July 15, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL16001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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