Evaluation of the Effect of an Experimental Gel Based on Jambu Extract ( Acmella Oleracea) in Reducing Post-bleaching Tooth Sensitivity : a Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of post bleaching sensitivity
研究概览
简要总结
This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing 10% jambu extract (Acmella Oleracea) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into two different groups - GE (A. Oleracea extract at 10%) and GP (placebo). The dental elements of the GE received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. The GP group also received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide.Post-bleaching sensitivity was collected through a form composed of the visual analogue scale (VAS). Color measurement was performed at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).
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
- 是
入选标准
- •good oral hygiene
- •absence of active caries lesions
- •never having undergone 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
EG (Experimental A. Oleracea extract gel)
The EG group received the application of experimental gel of A. Oleracea extract for post tooth bleaching sensitivity.
干预措施: EG (Experimental A. Oleracea extract gel) (Other)
GP (Gel placebo)
The GP group received the application of a placebo gel.
干预措施: GP (Gel placebo) (Other)
结局指标
主要结局
Assessment of post bleaching sensitivity
时间窗: 21 days
For the assessment of postoperative sensitivity, patients were instructed to fill out a form to record tooth sensitivity daily, during the 21 days of treatment, based on individual pain perception. This form was delivered at each bleaching session, being returned to the researcher in the following session, that is, always one week after each bleaching session. The evaluation form consisted of the 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 was 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 could be later measured with the aid of a millimeter ruler, thus obtaining the patient's level of pain intensity.
次要结局
- Color evaluation(Baseline (Ti) and one week after the 3rd whitening session (Tf).)
研究者
Cecy Martins Silva
Professor of the Graduate Program in Dentistry at the Federal University of Pará
Universidade Federal do Para