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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03588871
Other study ID # BL16001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2017
Est. completion date September 1, 2019

Study information

Verified date May 2018
Source Grupo de Investigação em Bioquímica e Biologia Oral
Contact João Silveira, PhD, MSc
Phone +351966168040
Email joao.silveira@campus.ul.pt
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date September 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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)
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
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)
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
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)
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

Locations

Country Name City State
Portugal Faculty of Dental Medicine of the University of Lisboa Lisboa

Sponsors (2)

Lead Sponsor Collaborator
Grupo de Investigação em Bioquímica e Biologia Oral Ivoclar Vivadent AG

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change on visually determination of tooth colour Determination of tooth colour using a visual tooth shade guide 2 weeks (before and after treatment)
Primary Change on spectrophotometer determination of tooth colour Determination of tooth colour using a spectrophotometer 2 weeks (before and after treatment)
Primary 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
Primary 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
Primary Objective evaluation of tooth colour change during follow-up Determination of tooth colour relapse using a spectrophotometer 1, 3 and 6 months
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