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NCT Number: NCT07594184

Does Hyaluronic Acid Help Relieve Dry Mouth?

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

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Odontologico Universidad de Barcelona

Barcelona, 08907, Spain

Location status: Recruiting

Location contact

Verónica C Schiavo, DDs, MSc

CONTACT

[email protected]

0034653515208

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Submucosal infiltration of non reticulated hyaluronic acid

Device

Submucosal infiltration of non reticulated hyaluronic acid will be administered all over the buccal cavity (floor of the mouth, yugal mucosa, lips)

Submucosal infiltration of Placebo

Device

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Veronica C Schiavo, DDs, Msc

CONTACT

[email protected]

0034653515208

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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