In-office Bleaching Using a Violet Light

NCT03207204 | Completed DMC

• 1 other identifier: 010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Bleaching; Dentin Sensitivity

Keywords

Dental bleaching; Color; Sensitivity; violet LED; Quality of life

Outcome Measures

Primary Outcomes (1)

• Color alteration

  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 Outcomes (5)

• Dental sensitivity

  Immediately after the treatment and 48 hours after the treatment

• Patient satisfaction regarding the treatment

  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

• Color change throughout 12 months 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

  Before, immediately after, 14 days, 3 months and 6 months after bleaching

Study Arms (8)

G1 - 35% Hydrogen peroxide bleaching

ACTIVE COMPARATOR

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

Procedure: 35% Hydrogen peroxide bleaching

G2 - 30% Carbamide peroxide bleaching

ACTIVE COMPARATOR

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

Procedure: 30% Carbamide peroxide bleaching

G3 - Violet LED bleaching 1

EXPERIMENTAL

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

Procedure: Violet LED bleaching 1

G4 - Violet LED bleaching 2

EXPERIMENTAL

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

Procedure: Violet LED bleaching 2

G5 - Photochemical protocol 1

EXPERIMENTAL

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

Procedure: Photochemical protocol 1

G6 - Photochemical protocol 2

EXPERIMENTAL

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

Procedure: Photochemical protocol 2

G7 - Hybrid technique 1

EXPERIMENTAL

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

Procedure: Hybrid technique 1

G8 - Hybrid technique 2

EXPERIMENTAL

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

Procedure: Hybrid technique 2

Interventions

35% Hydrogen peroxide bleaching PROCEDURE

Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.

G1 - 35% Hydrogen peroxide bleaching

30% Carbamide peroxide bleaching PROCEDURE

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.

G2 - 30% Carbamide peroxide bleaching

Violet LED bleaching 1 PROCEDURE

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.

G3 - Violet LED bleaching 1

Violet LED bleaching 2 PROCEDURE

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.

G4 - Violet LED bleaching 2

Photochemical protocol 1 PROCEDURE

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.

G5 - Photochemical protocol 1

Photochemical protocol 2 PROCEDURE

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.

G6 - Photochemical protocol 2

Hybrid technique 1 PROCEDURE

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.

G7 - Hybrid technique 1

Hybrid technique 2 PROCEDURE

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.

G8 - Hybrid technique 2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry of USP

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (2)

• Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.

  PMID: 20166405 BACKGROUND

• Boushell LW, Ritter AV, Garland GE, Tiwana KK, Smith LR, Broome A, Leonard RH. Nightguard vital bleaching: side effects and patient satisfaction 10 to 17 years post-treatment. J Esthet Restor Dent. 2012 Jun;24(3):211-9. doi: 10.1111/j.1708-8240.2011.00479.x. Epub 2011 Oct 11.

  PMID: 22691084 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Officials

• Patricia Freitas, PhD

  Associate Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 2, 2017
• Study Start: July 2, 2017
• Primary Completion: December 2, 2017
• Study Completion: July 2, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)