Clinical trial NCT02956070: Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity
Official title: Evaluation of Anti-inflammatory Steroids of Use in the Prevention of Tooth Sensitivity in Teeth Whitening Technique Office
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: dental bleaching
antiinflammatory
tooth sensitivity
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clinical randomized, triple-blind, used to measure the level of tooth sensitivity on volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.

Detailed description: The experimental design will follow the consolidated standards for test reports (CONSORT). After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal Fluminense University located in Nova Friburgo.Every Health Institute participants will be informed about the nature and objectives of the study.It will be one test study Clinical randomized, parallel, triple-blind, used to measure the level of tooth sensitivity volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.

Eligibility criteria: Inclusion Criteria:

* The selected volunteers should present a good general state of health, be at least 18 years of age, regardless of gender, color / race and ethnicity, sexual orientation, and gender identity.
* Volunteers must have an acceptable oral hygiene, present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
* These elements have to be healthy, that is, not having any kind of restoration.
* Volunteers must sign the consent form and clarification, have committed to return for periodic examinations and belong to the group of nonsmokers.

Exclusion Criteria:

* Do not have medical history of diseases that can affect the results of the study;
* subjects could not have made use of cigarettes in the last 30 days; have some important pathology in the oral cavity;
* not being pregnant and also are not breastfeeding;
* having any history of sensitivity or adverse reactions to anti-inflammatory used in the study;
* not having calculations or advanced periodontal disease;
* have not consumed drugs, alcohol or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
* The volunteers should not have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product and not present recession or exacerbated hypersensitivity history.

Primary outcomes:
measure: Visual Analogic Scale (0-100) for Tooth Sensibility.
timeFrame: One hour
measure: Visual Analogic Scale(0-100) for Tooth Sensibility.
timeFrame: Twenty four hours
measure: Visual Analogic Scale(0-100) for Tooth Sensibility.
timeFrame: Forty eight hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fluminense Federal University
name: Marcos O Barceleiro, MSD, PhD
role: PRINCIPAL_INVESTIGATOR
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