Does Hyaluronic Acid Help Relieve Dry Mouth?
2026年5月13日 更新者：Verónica Carolina Schiavo、University of Barcelona
Efficacy of Submucosal Hyaluronic Acid Infiltration in Improving the Sensation of Dry Mouth in Patients With Xerostomia: A Double-Blind Randomized Clinical Trial.
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
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Verónica C Schiavo, DDs, MSc
- 电话号码：0034653515208
- 邮箱：v.schiavo@ub.edu
学习地点
-
-
Barcelona
-
Barcelona、Barcelona、西班牙、08907
- 招聘中
- Hospital Odontologico Universidad de Barcelona
-
接触：
- Verónica C Schiavo, DDs, MSc
- 电话号码：0034653515208
- 邮箱：v.schiavo@ub.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Hyaluronic Acid
Submucosal infiltration of non reticulated hyaluronic acid
|
Submucosal infiltration of non reticulated hyaluronic acid will be administered all over the buccal cavity (floor of the mouth, yugal mucosa, lips)
|
|
安慰剂比较：Saline solution
Submucosal infiltration of placebo (0,9% saline solution)
|
Submucosal infiltration of placebo (Sterile 0.9% Sodium Chloride Solution for Injection) will be administered all over the buccal cavity (floor of the mouth, yugal mucosa, lips)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Efficacy of submucosal hyaluronic acid infiltration in the oral mucosa, compared to placebo infiltration, in improving symptoms associated with mucosal dehydration in patients with xerostomia.
大体时间：From enrollment to the end of treatment at 6 months
|
Change from baseline in xerostomia severity measured by the Xerostomia Inventory test which ranges from 11 to 55, with lower scores indicating less xerostomia-related impact, at 1 month, 2 months, 3 months, and 6 months after treatment.
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From enrollment to the end of treatment at 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Salivary secretion in patients with xerostomia before and after submucosal infiltration of hyaluronic acid or placebo
大体时间：From enrollment to the end of treatment at 6 months
|
Unstimulated and stimulated salivary flow rates measured by standardized saliva collection procedures to classify salivary flow as normal or reduced.
Salivary flow volumes (mL) will be collected over 5 minutes for unstimulated and stimulated saliva at baseline, and at 1 month, 2 months, 3 months, and 6 months after treatment under standardized morning conditions.
|
From enrollment to the end of treatment at 6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Presence of cracks, erosions, and ulcers on the lips and oral mucosa following submucosal infiltration of hyaluronic acid vs placebo
大体时间：From enrollment to the end of treatment at 6 months
|
Evaluated by standardized visual examination of the oral mucosa, with photographic documentation recorded when lesions are identified, at baseline, and at 1 month, 2 months, 3 months, and 6 months after submucosal infiltration of hyaluronic acid versus placebo.
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From enrollment to the end of treatment at 6 months
|
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Patient's sensation of comfort after submucosal infiltration of hyaluronic acid vs placebo
大体时间：From enrollment to the end of treatment at 6 months
|
Change from baseline in oral dryness assessed using the Visual Analog Scale (VAS) adapted for xerostomia, which ranges from 0 to 10, where 0 indicates no oral dryness and 10 indicates complete oral dryness; higher scores represent worse xerostomia severity (0 = no dryness; 1-3 = mild dryness; 3-7 = moderate dryness; 7-9 = severe dryness; 10 = total dryness).
|
From enrollment to the end of treatment at 6 months
|
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Patient's self reported anxiety status after submucosal infiltration of hyaluronic acid vs placebo
大体时间：From enrollment to the end of treatment after 6 months
|
Anxiety symptoms measured with the Generalized Anxiety Disorder 7-item scale (GAD-7), which ranges from 0 to 21, where higher scores indicate greater anxiety severity.
|
From enrollment to the end of treatment after 6 months
|
|
Patient's self reported depressive symptoms after submucosal infiltration of hyaluronic acid vs placebo
大体时间：From enrollment to the end of treatment after 6 months
|
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9), with scores ranging from 0 to 27, where higher scores reflect more severe depressive symptoms.
|
From enrollment to the end of treatment after 6 months
|
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Patient's self reported oral health related quality of life after submucosal infiltration of hyaluronic acid vs placebo
大体时间：From enrollment to the end of treatment after 6 months
|
Oral health-related quality of life evaluated using the Oral Health Impact Profile - short form (OHIP-Sp5), which ranges from 0 to 20; higher scores indicate worse oral health-related quality of life (greater negative impact).
|
From enrollment to the end of treatment after 6 months
|
|
Presence of oral mucosal pathology in patients diagnosed with xerostomia
大体时间：From enrollment to the end of treatment at 6 months
|
Evaluated by standardized visual examination of the oral mucosa, with photographic documentation recorded when oral mucosal pathology are identified, at baseline, and at 1 month, 2 months, 3 months, and 6 months after submucosal infiltration of hyaluronic acid versus placebo.
|
From enrollment to the end of treatment at 6 months
|
|
Changes in salivary pH following the intervention
大体时间：From enrollment to the end of treatment at 6 months
|
Change from baseline in salivary pH measured using pH indicator strips in unstimulated and stimulated saliva samples collected at baseline, and at 1 month, 2 months, 3 months, and 6 months after treatment.
|
From enrollment to the end of treatment at 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：José López, MD, PhD、University of Barcelona
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gil-Montoya JA, Silvestre FJ, Barrios R, Silvestre-Rangil J. Treatment of xerostomia and hyposalivation in the elderly: A systematic review. Med Oral Patol Oral Cir Bucal. 2016 May 1;21(3):e355-66. doi: 10.4317/medoral.20969.
- Salwowska NM, Bebenek KA, Zadlo DA, Wcislo-Dziadecka DL. Physiochemical properties and application of hyaluronic acid: a systematic review. J Cosmet Dermatol. 2016 Dec;15(4):520-526. doi: 10.1111/jocd.12237. Epub 2016 Jun 21.
- Patel M, Guni A, Nibali L, Garcia-Sanchez R. Interdental papilla reconstruction: a systematic review. Clin Oral Investig. 2024 Jan 17;28(1):101. doi: 10.1007/s00784-023-05409-0.
- Lorenzo-Pouso AI, Garcia-Garcia A, Perez-Sayans M. Hyaluronic acid dermal fillers in the management of recurrent angular cheilitis: A case report. Gerodontology. 2018 Jun;35(2):151-154. doi: 10.1111/ger.12329.
- Berreni N, Salerno J, Chevalier T, Alonso S, Mares P. Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study. BMC Womens Health. 2021 Aug 28;21(1):322. doi: 10.1186/s12905-021-01435-w.
- Hynnekleiv L, Magno M, Vernhardsdottir RR, Moschowits E, Tonseth KA, Dartt DA, Vehof J, Utheim TP. Hyaluronic acid in the treatment of dry eye disease. Acta Ophthalmol. 2022 Dec;100(8):844-860. doi: 10.1111/aos.15159. Epub 2022 May 5.
- Xu F, Laguna L, Sarkar A. Aging-related changes in quantity and quality of saliva: Where do we stand in our understanding? J Texture Stud. 2019 Feb;50(1):27-35. doi: 10.1111/jtxs.12356. Epub 2018 Aug 26.
- Kim YJ. Xerostomia: Advances and Challenges in Drug Development. Curr Drug Targets. 2024;25(5):301-305. doi: 10.2174/0113894501293941240228050343. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年11月11日
初级完成 (估计的)
2026年11月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年1月11日
首先提交符合 QC 标准的
2026年5月13日
首次发布 (实际的)
2026年5月18日
研究记录更新
最后更新发布 (实际的)
2026年5月18日
上次提交的符合 QC 标准的更新
2026年5月13日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There is no plan to share individual participant data (IPD) collected in this study.
Although all data will be anonymized, the clinical nature of the information and the limited sample size may pose a risk of re-identification.
Furthermore, the informed consent obtained from participants does not include authorization for data sharing with external researchers.
To ensure compliance with ethical standards and data protection regulations, IPD will not be made publicly available.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.