Effect of Gel Renewal During In-office Dental Bleaching

NCT04013659 | Unknown Phase 1

• 1 other identifier: 90670218.3.0000.5597
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Bleaching

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Dental sensitivity

  Immediately after treatment

• Dental sensitivity

  14 days after treatment

• Dental sensitivity

  2 months after treatment

Study Arms (2)

G1 - Permanence of the Whitening Gel

EXPERIMENTAL

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

G2 - Renewal of the Whitening Gel

EXPERIMENTAL

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

Interventions

Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation OTHER

After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED

G1 - Permanence of the Whitening Gel; G2 - Renewal of the Whitening Gel

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Ibirapuera: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Universidade Ibirapuera

São Paulo, São Paulo, 04661-100, Brazil

RECRUITING

Central Study Contacts

Karen M Ramalho, PhD

CONTACT

11989385397; karenramalho@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Split-mouth model design

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: July 10, 2019
• Study Start: March 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)