Effect of Gel Renewal During In-office Dental Bleaching

Effect of Gel Renewal During In-office Dental Bleaching Using Violet LED Light as Photo-accelerator. A Randomized Blind Clinical Trial

Considering the lack of studies related to the violet LED light (405-410nm), applied to tooth whitening, as well as the lack of protocols for its use, this study aims to evaluate if bleaching gel renewal during dental office whitening associated with Violet LED light interferes with final color result and postoperative sensitivity in a randomized, blinded, split-mouth study. Thirty-three volunteers will be selected to participate in the study (n = 33), and the study groups will be: G1 (Permanence of the Whitening Gel on the tooth enamel for 15 minutes) and G2 (3 Whitening Gel renewal every 5 minutes - Total of 15 minutes). In both G1 and G2, teeth will be illuminated with the Violet LED (405-410nm). In the same patient the two treatments (G1 and G2) will be performed, with a split-mouth protocol. The primary outcome will be immediate and mediated color change, quantitatively assessed by colorimetric (color scale) and spectrophotometry tests. Dental sensitivity will also be evaluated during and after tooth whitening using the VAS pain scale. There will be 3 whitening sessions with a 7-day interval between them. The alteration of color and presence of sensitivity will also be evaluated at the times of 14 days and 2 months after the whitening ends. A gel containing 35% hydrogen peroxide will be used. The final color evaluator and responsible for interviewing the patient about the sensitivity will be blind as to which treatment was applied on each side of the patient's arcade.

Study Overview

• Status: Unknown
• Conditions: Tooth Bleaching
• Intervention / Treatment: Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04661-100
      • Recruiting
      • Universidade Ibirapuera
      • Contact: Karen M Ramalho, PhD; Phone Number: +55 11 989385397; Email: karenramalho@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good oral hygiene conditions
• Good general health conditions and without systemic disease
• Presence of all teeth, without caries, periodontal disease, restorations, endodontic treatment, crowns
• Patients with dental color A3 or darker, according to the VITA * Classical Color Scale.

Exclusion Criteria:

• Pregnant and lactating female patients
• Presence of caries, periodontal disease or any other infectious source in the oral cavity
• Systematic use of tobacco and alcoholic beverages
• Chronic use of corticosteroids, as well as who makes use of analgesics or anti-inflammatories before or during 48 hours after dental bleaching
• Patients with dentin hypersensitivity
• Patients with tooth color alteration by tetracycline, fluorosis, endodontic treatment.
• Volunteers who use removable prostheses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G1 - Permanence of the Whitening Gel; Permanence of the Whitening Gel (Biological Product: 35% Hydrogen Peroxide) on the tooth enamel during the 15 minutes of dental-bleaching	Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation; After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED
Experimental: G2 - Renewal of the Whitening Gel; 3 Whitening Gel (Biological Product: 35% Hydrogen Peroxide) renewal every 5 minutes during the 15 minutes of dental-bleaching	Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation; After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teeth Color 1	assessed quantitatively by colorimetric color scale	Immediately after treatment
Teeth Color 2	assessed quantitatively by spectrophotometry	Immediately after treatment
Teeth Color 1	assessed quantitatively by colorimetric color scale	14 days after treatment
Teeth Color 2	assessed quantitatively by spectrophotometry	14 days after treatment
Teeth Color 1	assessed quantitatively by colorimetric color scale	2 months after treatment
Teeth Color 2	assessed quantitatively by spectrophotometry	2 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental sensitivity	Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)	Immediately after treatment
Dental sensitivity	Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)	14 days after treatment
Dental sensitivity	Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain)	2 months after treatment

Collaborators and Investigators

• Sponsor: Universidade Ibirapuera
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: June 9, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: 90670218.3.0000.5597

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