RecruitingNot ApplicableNCT07594184

Does Hyaluronic Acid Help Relieve Dry Mouth?

Efficacy of Submucosal Hyaluronic Acid Infiltration in Improving the Sensation of Dry Mouth in Patients With Xerostomia: A Double-Blind Randomized Clinical Trial.


Sponsor

University of Barcelona

Enrollment

40 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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)

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Interventions

DEVICESubmucosal 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)

DEVICESubmucosal 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)


Locations(1)

Hospital Odontologico Universidad de Barcelona

Barcelona, Barcelona, Spain

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NCT07594184


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