Does Hyaluronic Acid Help Relieve Dry Mouth?
13. Mai 2026 aktualisiert von: 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:
- Does hyaluronic acid improve the sensation of dry mouth?
- What side effects may occur after treatment?
- How long does the effect of the treatment last?
- 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
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Verónica C Schiavo, DDs, MSc
- Telefonnummer: 0034653515208
- E-Mail: v.schiavo@ub.edu
Studienorte
-
-
Barcelona
-
Barcelona, Barcelona, Spanien, 08907
- Rekrutierung
- Hospital Odontologico Universidad de Barcelona
-
Kontakt:
- Verónica C Schiavo, DDs, MSc
- Telefonnummer: 0034653515208
- E-Mail: v.schiavo@ub.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Hyaluronic Acid
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-Komparator: Saline solution
Submucosal infiltration of placebo (0,9% saline solution)
|
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)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Salivary secretion in patients with xerostomia before and after submucosal infiltration of hyaluronic acid or placebo
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Presence of cracks, erosions, and ulcers on the lips and oral mucosa following submucosal infiltration of hyaluronic acid vs placebo
Zeitfenster: 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
|
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Patient's sensation of comfort after submucosal infiltration of hyaluronic acid vs placebo
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: José López, MD, PhD, University of Barcelona
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Kim YJ. Xerostomia: Advances and Challenges in Drug Development. Curr Drug Targets. 2024;25(5):301-305. doi: 10.2174/0113894501293941240228050343. No abstract available.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
11. November 2025
Primärer Abschluss (Geschätzt)
1. November 2026
Studienabschluss (Geschätzt)
1. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
11. Januar 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Mai 2026
Zuerst gepostet (Tatsächlich)
18. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 47/2025
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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