Does Hyaluronic Acid Help Relieve Dry Mouth?

May 13, 2026 updated by: 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:

  1. Does hyaluronic acid improve the sensation of dry mouth?
  2. What side effects may occur after treatment?
  3. How long does the effect of the treatment last?
  4. 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Verónica C Schiavo, DDs, MSc
  • Phone Number: 0034653515208
  • Email: v.schiavo@ub.edu

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Odontologico Universidad de Barcelona
        • Contact:
          • Verónica C Schiavo, DDs, MSc
          • Phone Number: 0034653515208
          • Email: v.schiavo@ub.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid
Submucosal infiltration of non reticulated hyaluronic acid
Device: 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)
Placebo Comparator: Saline solution
Submucosal infiltration of placebo (0,9% saline solution)
Device: Submucosal infiltration of Placebo
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary secretion in patients with xerostomia before and after submucosal infiltration of hyaluronic acid or placebo
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of cracks, erosions, and ulcers on the lips and oral mucosa following submucosal infiltration of hyaluronic acid vs placebo
Time Frame: 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.
From enrollment to the end of treatment at 6 months
Patient's sensation of comfort after submucosal infiltration of hyaluronic acid vs placebo
Time Frame: 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
Patient's self reported anxiety status after submucosal infiltration of hyaluronic acid vs placebo
Time Frame: 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
Time Frame: 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
Patient's self reported oral health related quality of life after submucosal infiltration of hyaluronic acid vs placebo
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Investigators

  • Study Director: José López, MD, PhD, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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