In-office Bleaching Using a Violet Light

Not Applicable

Completed

• Conditions: Dentin Sensitivity; Tooth Bleaching
• Interventions: Procedure: Photochemical protocol 2; Procedure: Hybrid technique 2; Procedure: Violet LED bleaching 2; Procedure: 35% Hydrogen peroxide bleaching; Procedure: 30% Carbamide peroxide bleaching; Procedure: Violet LED bleaching 1; Procedure: Photochemical protocol 1; Procedure: Hybrid technique 1

• Registration Number: NCT03207204
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-30
• Study Start: 2017-07-02
• Study First Posted: 2017-07-02
• Primary Completion: 2017-12-02
• Study Completion: 2020-07-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G6 - Photochemical protocol 2	Photochemical protocol 2	In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week)
G8 - Hybrid technique 2	Hybrid technique 2	Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week).
G4 - Violet LED bleaching 2	Violet LED bleaching 2	In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week);
G1 - 35% Hydrogen peroxide bleaching	35% Hydrogen peroxide bleaching	In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week);
G2 - 30% Carbamide peroxide bleaching	30% Carbamide peroxide bleaching	In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week);
G3 - Violet LED bleaching 1	Violet LED bleaching 1	In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week);
G5 - Photochemical protocol 1	Photochemical protocol 1	In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week);
G7 - Hybrid technique 1	Hybrid technique 1	hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week)

Primary Outcome Measures

Name	Time	Method
Color alteration	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction regarding the treatment	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.
Quality of life of the patients	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.
Color change throughout 6 months with a clinical spectrophotometer	Before, immediately after, 14 days, 3 months and 6 months after bleaching	The evaluation will be performed with a clinical spectrophotometer
Dental sensitivity	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.
Color change throughout 12 months with a visual color scale	Before, immediately after, 14 days, 3 months, 6 months and 12 months after bleaching	The evaluation will be performed with a visual color scale

Trial Locations

Locations (1)

School of Dentistry of USP; 🇧🇷 São Paulo, SP, Brazil