Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07594184

Efficacy of Submucosal Hyaluronic Acid Injection for Dry Mouth Relief in Adults with Xerostomia: A Double-Blind Randomized Clinical Trial

Led by University of Barcelona · Updated on 2026-05-18

40

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find out if injecting hyaluronic acid under the mucous membrane can help relieve dry mouth symptoms in adults with xerostomia. The study will compare hyaluronic acid to a placebo to assess its effect on dry mouth sensation, side effects, duration of treatment benefits, and changes in saliva flow and pH. Participants will receive submucosal injections of either hyaluronic acid or a placebo solution throughout the mouth, including the floor of the mouth, cheek lining, and lips. Treatments will be given once monthly, and the study will last for six months with follow-up visits each month. During the study, participants will have monthly clinic visits for evaluations but will not need to perform any tasks at home. Researchers will monitor symptoms, saliva secretion, and safety throughout the six-month treatment period to understand the treatment's effectiveness and any side effects.

CONDITIONS

Brief Title

Does Hyaluronic Acid Help Relieve Dry Mouth?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 6 months

Participants receive submucosal infiltration of either hyaluronic acid or placebo in the oral mucosa to help relieve dry mouth symptoms.

Visits occur throughout the 6 months of treatment

Trial Site Locations

Total: 1 location

1

Hospital Odontologico Universidad de Barcelona

Barcelona, Barcelona, Spain, 08907

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Research Team

V

Veronica C Schiavo, DDs, Msc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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