NCT07594184

Brief 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. 1.Does hyaluronic acid improve the sensation of dry mouth?
  2. 2.What side effects may occur after treatment?
  3. 3.How long does the effect of the treatment last?
  4. 4.Are there changes in salivary flow and pH after treatment?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 11, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

January 11, 2026

Last Update Submit

May 13, 2026

Conditions

Xerostomia

Outcome Measures

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.

    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 Outcomes (1)

  • Salivary secretion in patients with xerostomia before and after submucosal infiltration of hyaluronic acid or placebo

    From enrollment to the end of treatment at 6 months

Other Outcomes (7)

  • Presence of cracks, erosions, and ulcers on the lips and oral mucosa following submucosal infiltration of hyaluronic acid vs placebo

    From enrollment to the end of treatment at 6 months

  • Patient's sensation of comfort after submucosal infiltration of hyaluronic acid vs placebo

    From enrollment to the end of treatment at 6 months

  • Patient's self reported anxiety status after submucosal infiltration of hyaluronic acid vs placebo

    From enrollment to the end of treatment after 6 months

  • +4 more other outcomes

Study Arms (2)

Hyaluronic Acid

EXPERIMENTAL

Submucosal infiltration of non reticulated hyaluronic acid

Device: Submucosal infiltration of non reticulated hyaluronic acid

Saline solution

PLACEBO COMPARATOR

Submucosal infiltration of placebo (0,9% saline solution)

Device: Submucosal infiltration of Placebo

Interventions

Submucosal infiltration of non reticulated hyaluronic acidDEVICE

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

Hyaluronic Acid
Submucosal infiltration of PlaceboDEVICE

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)

Saline solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Odontologico Universidad de Barcelona

Barcelona, Barcelona, 08907, Spain

RECRUITING

Related Publications (8)

  • 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.

    PMID: 38231354BACKGROUND

  • 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.

    PMID: 29733533BACKGROUND

  • 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.

    PMID: 34454465BACKGROUND

  • 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.

    PMID: 35514082BACKGROUND

  • 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.

    PMID: 27324942BACKGROUND

  • 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.

    PMID: 27031061BACKGROUND

  • 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.

    PMID: 30091142BACKGROUND

  • Kim YJ. Xerostomia: Advances and Challenges in Drug Development. Curr Drug Targets. 2024;25(5):301-305. doi: 10.2174/0113894501293941240228050343. No abstract available.

    PMID: 38424432BACKGROUND

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • José López, MD, PhD

    University of Barcelona

    STUDY DIRECTOR

Central Study Contacts

Veronica C Schiavo, DDs, Msc

CONTACT

0034653515208v.schiavo@ub.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2026

First Posted

May 18, 2026

Study Start

November 11, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)