Clinical trial NCT04013659: Effect of Gel Renewal During In-office Dental Bleaching
Official title: Effect of Gel Renewal During In-office Dental Bleaching Using Violet LED Light as Photo-accelerator. A Randomized Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Tooth Bleaching
Lead sponsor: Universidade Ibirapuera
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-07-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split-mouth model design
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Teeth Color 1
timeFrame: Immediately after treatment
measure: Teeth Color 2
timeFrame: Immediately after treatment
measure: Teeth Color 1
timeFrame: 14 days after treatment
measure: Teeth Color 2
timeFrame: 14 days after treatment
measure: Teeth Color 1
timeFrame: 2 months after treatment
measure: Teeth Color 2
timeFrame: 2 months after treatment
Secondary outcomes:
measure: Dental sensitivity
timeFrame: Immediately after treatment
measure: Dental sensitivity
timeFrame: 14 days after treatment
measure: Dental sensitivity
timeFrame: 2 months after treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Ibirapuera
state: SP
Study officials:
References: