Effects of a 0.5% Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Post-whitening sensitivity assessment
研究概览
简要总结
This randomized, parallel, double-blind, placebo-controlled clinical study aims to investigate the effects of an experimental 0.5% propolis gel on controlling tooth sensitivity and discoloration after in-office dental bleaching. Sixty-six volunteers will be selected according to inclusion and exclusion criteria and will be randomly assigned to three experimental groups: Placebo - received application of a gel without active ingredient (K-Y Original), KF2 - received application of 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and Propolis 0.5% - application of the experimental 0.5% propolis gel. All participants will undergo two in-office bleaching sessions with 35% hydrogen peroxide, with seven-day intervals between them. The bleaching agent will be applied for 30 minutes. The desensitizing agents will be applied prior to bleaching and kept in contact with the vestibular dental surface for ten minutes. Sensitivity will be monitored daily using the Visual Analogue Scale for fourteen days, while color change will be determined by spectrophotometry, using the parameters of the CIELab* system and calculation of ΔE00, measured before bleaching (T0) and 7 days after the second bleaching session (T1). The data will be subjected to statistical analysis according to sample distribution, adopting a power of 80% and a significance level of 5%.
详细描述
All groups will undergo in-office whitening treatment, carried out in 2 sessions with a 7-day interval, according to the steps described below:
Prophylaxis; Application of gingival barrier; Application of desensitizing agent or placebo, according to the established groups; Handling of the whitening material following the manufacturer's instructions: application of Whiteness HP 35% whitening gel for 30 minutes Final removal of the whitening gel and gingival barrier, followed by rinsing with water.
The application of the desensitizing agent or its placebo will follow this sequence:
Relative isolation with cotton rolls; Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; Rinsing with water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good oral hygiene
- •absence of active caries lesions
- •never having previous whitening therapy
- •not present dental hypersensitivity
- •don't be a smoker
- •not be pregnant
- •present at least 28 teeth in the oral cavity.
排除标准
- •volunteers who were under orthodontic treatment,
- •presence of periodontal disease
- •dental cracks or fractures
- •restorations and prostheses on anterior teeth
- •extensive molar restorations
- •gastroesophageal disorders
- •severe internal dental darkening
- •presence of dentinal exposure in anterior and/or posterior teeth.
研究组 & 干预措施
Placebo- KY original gel
The Placebo group received the application of placebo gel for post tooth bleaching sensitivity.
干预措施: Placebo - gel KY original (Other)
KF2- Potassium nitrate
The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity.
干预措施: KF2- Potassium nitrate (Other)
Propolis- Propolis 0,5% gel
The Propolis group received the application of experimental gel of propolis 0,5% for post tooth bleaching sensitivity.
干预措施: Propolis gel (Other)
结局指标
主要结局
Post-whitening sensitivity assessment
时间窗: 14 days
To assess post-operative sensitivity, patients will be instructed to fill out a form to record daily tooth sensitivity during the 14 days of treatment, based on their individual perception of pain. This form will be handed out at each whitening session and returned to the researcher at the following session, that is, always one week after each whitening session. The assessment form will consist of a visual analogue scale (VAS). This scale consists of a 10 cm horizontal line with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day. So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the patient\'s pain intensity level.
次要结局
- Color evaluation(Baseline (T0) and one week after the 2rd whitening session (T1))
研究者
Cecy Martins Silva
Professor of the Graduate Program in Dentistry at the Federal University of Pará
Universidade Federal do Para
