In-office Bleaching Using a Violet Light

November 3, 2020 updated by: Patricia Moreira de Freitas, University of Sao Paulo

Long-term Clinical Evaluation of In-office Dental Bleaching Using a Violet Light (405-410 nm)

The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life. After being informed of the objectives of the study, 200 participants will be selected and randomly divided into a treatment group (n = 25): G1 - 35% hydrogen peroxide (HP) (4 sessions, 1 session/week); G2 - 30% carbamide peroxide (CP) (4 sessions, 1 session/week); G3 - Violet LED (405-410 nm, 4 sessions, 1 session/week); G4 - Violet LED (405-410 nm, 4 sessions, 2 sessions/week); G5 - Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); G6 - Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week); G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week); G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week). The color evaluation will be performed at predetermined times (before and immediately after treatment, 14 days after completion of bleaching and 3, 6 and 12 months after completion of bleaching), and quantitatively evaluated by colorimetric tests (objective and subjective) and spectrophotometry. In addition, it will be evaluated the tooth sensitivity during and after (48 hours) tooth whitening (VAS Scale), satisfaction with the treatment and impact on quality of life (OHIP-14 questionnaire). The data, except for survey data of satisfaction (descriptive evaluation), will be subjected to statistical analysis to determine the homogeneity and normality of the sample and for comparison between treatment groups, considering a 5% significance level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life.

This study was approved by the research ethics committee of School of Dentistry of University of Sao Paulo (Protocol# 1.981.756). The experimental design is in according to CONSORT. The present research will be a blind, parallel and randomized study with similar allocation between the treatment groups. It will be included 200 participants, selected among the patients of the Special Laboratory of lasers in dentistry (LELO-FOUSP). After being being informed of the objectives of the study the participants will be randomly divided into a treatment group (n = 25):

G1 - In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week).

G2 - In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week).

G3 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week).

G4 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week).

G5 - In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week).

G6 - In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week).

G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week).

G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week).

The primary outcome of this study is the color alteration, which will be evaluated quantitatively by colorimetric (subjective) and spectrophotometric (objective) tests. Additionally, will be evaluated dental sensitivity during and after treatment (predetermined times), patient satisfaction regarding the treatment, and impact on patient quality of life (questionnaire OHIP-14).

The color measurement will be blind, in predetermined times (before the treatment, immediately after the treatment, 14 days after, 3 months after, 6 months after and 12 months after). It will be performed by two methods: subjectively, with a color scale; and objectively, with a clinical spectrophotometer.

The evaluation of dental sensitivity will be measured with a Visual analogue scale (VAS). It will be performed immediately after the treatment and 48 hours after the treatment.

The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment, and will be applied 14 days after the end of treatment, 3 months after, 6 months after and 12 months after.

The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire, which will be applied after the end of the treatment.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05508-000
        • School of Dentistry of USP

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 to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of all the teeth, without restorations or caries on anterior teeth.
  • Patients presenting the canine tooth color A3 (according to Vita classical scale) or darker.

Exclusion Criteria:

  • Patients presenting systemic pathologies
  • Patients presenting periodontal diseases
  • Smokers or patients with systematic use of alcohol
  • Patients presenting teeth with color alterations by tetracycline, fluorosis, endodontic treatments.
  • Patients with historic of self-referenced sensitivity
  • Pregnant or Breastfeeding period patients
  • Presence of restorations on anterior teeth
  • Patients presenting bruxism or systematic use of analgesics or anti-inflammatory drugs

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: G1 - 35% Hydrogen peroxide bleaching
In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week);
Procedure: 35% Hydrogen peroxide bleaching
Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
Active Comparator: G2 - 30% Carbamide peroxide bleaching
In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week);
Procedure: 30% Carbamide peroxide bleaching
Protocol: Application of 35% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
Experimental: G3 - Violet LED bleaching 1
In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week);
Procedure: Violet LED bleaching 1
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Experimental: G4 - Violet LED bleaching 2
In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week);
Procedure: Violet LED bleaching 2
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 2 times a week.
Experimental: G5 - Photochemical protocol 1
In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week);
Procedure: Photochemical protocol 1
Protocol: Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Experimental: G6 - Photochemical protocol 2
In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week)
Procedure: Photochemical protocol 2
Protocol: Application of 30% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Experimental: G7 - Hybrid technique 1
hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week)
Procedure: Hybrid technique 1
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 35% Hydrogen peroxide to act concomitantly with the light.
Experimental: G8 - Hybrid technique 2
Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week).
Procedure: Hybrid technique 2
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 30% Carbamide peroxide to act concomitantly with the light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color alteration
Time Frame: 12 months after the treatment
The color measurement will be blind, in predetermined time (12 months after the treatment). It will be performed with a clinical spectrophotometer.
12 months after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental sensitivity
Time Frame: Immediately after the treatment and 48 hours after the treatment
The evaluation of dental sensitivity will be measured with a Visual analogue scale (VAS). It will be performed immediately after the treatment and 48 hours after the treatment.
Immediately after the treatment and 48 hours after the treatment
Patient satisfaction regarding the treatment
Time Frame: 14 days after the end of treatment, 3 months after, 6 months after and 12 months after
The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment, and will be applied 14 days after the end of treatment, 3 months after, 6 months after and 12 months after.
14 days after the end of treatment, 3 months after, 6 months after and 12 months after
Quality of life of the patients
Time Frame: Immediately after the end of bleaching
The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire, which will be applied after the end of the treatment.
Immediately after the end of bleaching
Color change throughout 12 months with a visual color scale
Time Frame: Before, immediately after, 14 days, 3 months, 6 months and 12 months after bleaching
The evaluation will be performed with a visual color scale
Before, immediately after, 14 days, 3 months, 6 months and 12 months after bleaching
Color change throughout 6 months with a clinical spectrophotometer
Time Frame: Before, immediately after, 14 days, 3 months and 6 months after bleaching
The evaluation will be performed with a clinical spectrophotometer
Before, immediately after, 14 days, 3 months and 6 months after bleaching

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Patricia Freitas, PhD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 2, 2017

Primary Completion (Actual)

December 2, 2017

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010

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

No

Studies a U.S. FDA-regulated device product

No

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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