Effect of Gel Renewal During In-office Dental Bleaching

NCT ID: NCT04013659

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Universidade Ibirapuera

OTHER

Sponsor Role: lead

Responsible Party

Karen Müller Ramalho

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Ibirapuera

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Karen M Ramalho, PhD

Role: CONTACT

karenramalho@hotmail.com

11989385397 ext. +5511

Facility Contacts

Karen M Ramalho, PhD

Role: primary

karenramalho@hotmail.com

+55 11 989385397

Other Identifiers

90670218.3.0000.5597

Identifier Type: -

Identifier Source: org_study_id