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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588871
• Other study ID #: BL16001
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Quality of Life
• Tooth Bleaching

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