NCT07594184招募中不适用
Efficacy of Submucosal Hyaluronic Acid Infiltration in Improving the Sensation of Dry Mouth in Patients With Xerostomia: A Double-Blind Randomized Clinical Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if hyaluronic acid infiltration helps relieve dry mouth symptoms in adults with xerostomia. It will also assess the safety and duration of the treatment's effects.
The main questions it aims to answer are:
- Does hyaluronic acid improve the sensation of dry mouth?
- What side effects may occur after treatment?
- How long does the effect of the treatment last?
- Are there changes in salivary flow and pH after treatment?
Researchers will compare hyaluronic acid to a placebo (a look-alike substance with no active ingredient) to determine its effectiveness.
Participants will:
Receive submucosal injection of either hyaluronic acid or placebo Visit the clinic once a month for 6 months for follow-up evaluations Not be required to perform any tasks at home
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
- Triple (Participant, 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
- 否
入选标准
- •Patients over 18 years of age
- •Patients reporting symptoms compatible with xerostomia for at least one year
- •Patients who agree to cooperate in the study, comply with the follow-up plan, and sign the informed consent
排除标准
- •Underage patients
- •Pregnant patients
- •Patients on antiplatelet or anticoagulant therapy
- •Patients with a history of adverse reactions to hyaluronic acid infiltration
- •Patients with active infectious diseases in the oral cavity
- •Immunocompromised patients
- •Patients with other active diseases affecting the oral mucosa
- •Patients with uncontrolled autoimmune diseases
- •Patients allergic to lidocaine and/or mepivacaine
- •Patients undergoing active chemotherapy and/or radiotherapy for head and neck
- •Non-cooperative patients (e.g., psychomotor dysfunctions and behavioral disorders)
研究者
Verónica Carolina Schiavo
Associate Professor
University of Barcelona
研究点 (1)
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