XerostomiaNCT07594184
Does Hyaluronic Acid Help Relieve Dry Mouth?
A study testing Submucosal infiltration of non reticulated hyaluronic acid in people with Xerostomia, run by University of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Submucosal infiltration of non reticulated hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Odontologico Universidad de Barcelona
Barcelona, Barcelona, 08907
Verónica C Schiavo, DDs, MSc, 0034653515208, v.schiavo@ub.edu
About this study
Official title: 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:
Read more
- 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
- Conditions
- Xerostomia
- Being tested
- Submucosal infiltration of non reticulated hyaluronic acid, Submucosal infiltration of Placebo
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid | Experimental | Submucosal infiltration of non reticulated hyaluronic acid Receives: Device: Submucosal infiltration of non reticulated hyaluronic acid |
| Saline solution | Placebo comparator | Submucosal infiltration of placebo (0,9% saline solution) Receives: Device: Submucosal infiltration of Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start11 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Verónica Carolina Schiavo, University of Barcelona
- Investigators
- José López, MD, PhD, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594184
- Sponsor's protocol ID
- 47/2025
- Status last verified
- May 2026
- First submitted
- 11 Jan 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38231354Lorenzo-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.
PubMed 29733533Berreni 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.
PubMed 34454465Hynnekleiv 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.
PubMed 35514082Salwowska 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.
PubMed 27324942Gil-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.
PubMed 27031061Xu 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.
PubMed 30091142Kim YJ. Xerostomia: Advances and Challenges in Drug Development. Curr Drug Targets. 2024;25(5):301-305. doi: 10.2174/0113894501293941240228050343. No abstract available.
PubMed 38424432
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Submucosal Hyaluronic Acid Infiltration in Improving the Sensation of Dry Mouth in Patients With Xerostomia: A Double-Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07594184
- Acronym / sponsor ID
- 47/2025
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid | Experimental | Device: Submucosal infiltration of non reticulated hyaluronic acidSubmucosal infiltration of non reticulated hyaluronic acid |
| Saline solution | Placebo comparator | Device: Submucosal infiltration of PlaceboSubmucosal infiltration of placebo (0,9% saline solution) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submucosal infiltration of non reticulated hyaluronic acidSubmucosal infiltration of non reticulated hyaluronic acid will be administered all over the buccal cavity (floor of the mouth, yugal mucosa, lips) | Device | Hyaluronic Acid |
| Submucosal infiltration of PlaceboSubmucosal 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) | Device | Saline solution |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 38231354Patel 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.
- Background: PubMed 29733533Lorenzo-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.
- Background: PubMed 34454465Berreni 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.
- Background: PubMed 35514082Hynnekleiv 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.
- Background: PubMed 27324942Salwowska 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.
- Background: PubMed 27031061Gil-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.
- Background: PubMed 30091142Xu 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.
- Background: PubMed 38424432Kim YJ. Xerostomia: Advances and Challenges in Drug Development. Curr Drug Targets. 2024;25(5):301-305. doi: 10.2174/0113894501293941240228050343. No abstract available.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José López, MD, PhD study director
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submucosal infiltration of non reticulated hyaluronic acid in people with Xerostomia, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica C Schiavo, DDs, Msc (0034653515208, v.schiavo@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07594184, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.