Xerostomia
Conditions
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. 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
Interventions
DEVICESubmucosal 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)
DEVICESubmucosal infiltration of Placebo
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)
Sponsors
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Spain
Contacts
CONTACTVeronica C Schiavo, DDs, Msc
STUDY_DIRECTORJosé López, MD, PhD
University of Barcelona
Outcome results
None listed