Evaluation of Anti-inflammatory Steroids of Use in the Prevention of Tooth Sensitivity in Teeth Whitening Technique Office
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Visual Analogic Scale (0-100) for Tooth Sensibility.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental
35 patients in this group will undergo the whitening procedure using the Dexamethasone acetate intervention.
干预措施: Dexamethasone acetate (Drug)
Placebo
35 patients in this group will undergo the whitening procedure using the Potassium Nitrate intervention
干预措施: Potassium Nitrate (Drug)
结局指标
主要结局
Visual Analogic Scale (0-100) for Tooth Sensibility.
时间窗: One hour
The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Visual Analogic Scale(0-100) for Tooth Sensibility.
时间窗: Forty eight hours
The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
次要结局
未报告次要终点
研究者
Luiz Augusto da Costa Poubel
Professor
Universidade Federal Fluminense