Evaluation of the Effect of Minimally Invasive Procedures Used in Management of Salivary Ductal Pathologies on Patients' Symptomatology and Gland Function - A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Objective salivary gland performance (salivary flow measurement)
研究概览
简要总结
Aim of the current study was to evaluate the minimally invasive techniques in the management of salivary gland ductal pathologies
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •All patients manifesting with either submandibular or parotid salivary gland ductal pathologies including:
- •Sialolithiasis (salivary stones).
- •Salivary ductal stenosis or stricture.
- •Children with juvenile recurrent parotitis.
- •Sjogren's syndrome.
- •Radio-iodine induced sialadenitis.
排除标准
- •Patients who are unfit for surgery.
- •Patients with previous submandibular or parotid surgical resection.
- •Patients with salivary tumors either benign or malignant.
结局指标
主要结局
Objective salivary gland performance (salivary flow measurement)
时间窗: up to 12 months
We have chosen 6 minutes as our standard time to collect saliva and we have chosen on purpose to collect saliva separately from the two parotids and jointly from the submandibular gland. A 5cmx5cm gaze is applied on the papilla of each Stenson duct and a third one is placed under the tongue. All these tampons are weighted separately after 6 minutes and the results collected.
Subjective salivary gland performance
时间窗: up to 12 months
This was done using a questionnaire to measure salivary score (this questionnaire is formulated by the multidisciplinary salivary gland society "MSGS"). The questionnaire consists of 20 questions divided in two groups: 13 regarding xerostomia and 7 regarding sialadenitis. Each question is scored from 0 to 10 and the total score could vary from 0 to 200 points.
次要结局
未报告次要终点
研究者
Aya Sakr
Assistant Lecturer of Oral and Maxillofacial Surgery
Alexandria University