Association Between Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery: Randomized Clinical Trial, Placebo-controlled, Double-blind
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Trismus - Vertical Opening
研究概览
简要总结
A randomized clinical trial will be performed in parallel, placebo controlled, triple-blind to evaluate the effectiveness of the association Bromelina and Horse-chestnut (titrated in escin) (Noflogo®, Mavenpharma s.r.l., Rome, Italy) in the management of post trauma-surgery following surgery periodontal and implant surgery.
详细描述
At least 50 volunteers between the ages of 18 and 50, will be enlisted, with the need to perform one of the interventions described above and that fall within the criteria of inclusion.
The study will be carried out in accordance with the Helsinki Declaration on In Vivo Studies and will be initiated with the approval of the Internal Review Board of the University of L'Aquila.
The protocol follows the guidelines of the CONSORT Statement for parallel studies and will be recorded on the data base clinicaltrials.gov.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple blind randomization and computer-based random allocation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No signs of gingival inflammation;
- •FMBS and FMPS ≤ 20% after non-surgical causal therapy (Only for patients undergoing periodontal surgery)
- •Smokers have to indicate how many cigarettes they smoke and how long have they been smoking
排除标准
- •Gingival inflammation
- •Positive anamensis for relevant systemic pathologies (renal, cardiovascular, hepatic, infectious, neoplastic and diabetological)
- •Treatment with anti-inflammatory and/or antibiotics in the two weeks preceding the start of the trial
- •History of allergy to one or more components of the medication to be tested
- •Pregnant women
结局指标
主要结局
Trismus - Vertical Opening
时间窗: 7 days
A calibre has been used to measure vertical opening.
Edema - Cheek Volume
时间窗: 7 days
The distance between the angle of the mouth and the lobe of the ear and the distance between the outer side of the eye and the angle of the jaw, following the bulge of the cheek. In addition, where possible, a facial scanner has been used.
Pain - (VAS)
时间窗: 7 days
The patient fills in the visual analog scale. This scale has values from 0 to 10 where 0 indicates "no pain" and 10 indicates "worst pain imaginable"
次要结局
未报告次要终点
研究者
Enrico Marchetti
Prof. Enrico Marchetti
University of L'Aquila