Does Hyaluronic Acid Help Relieve Dry Mouth?
ConditionXerostomia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Barcelona
About this 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:
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Underage patients
Pregnant patients
Patients on antiplatelet or anticoagulant therapy
Patients with a history of adverse reactions to hyaluronic acid infiltration
Trial design
Design model
Parallel
Treatments tested in this trial
Submucosal infiltration of non reticulated hyaluronic acid
DeviceSubmucosal 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
DeviceSubmucosal 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)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Hyaluronic AcidExperimental treatment 1 intervention
Group B: Saline solutionPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 6 monthsSecondary 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.
Time frame
From enrollment to the end of treatment at 6 monthsOther outcomes
1
Presence of cracks, erosions, and ulcers on the lips and oral mucosa following submucosal infiltration of hyaluronic acid vs placebo
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.
Time frame
From enrollment to the end of treatment at 6 months2
Patient's sensation of comfort after submucosal infiltration of hyaluronic acid vs placebo
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).
Time frame
From enrollment to the end of treatment at 6 months3
Patient's self reported anxiety status after submucosal infiltration of hyaluronic acid vs placebo
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.
Time frame
From enrollment to the end of treatment after 6 months4
Patient's self reported depressive symptoms after submucosal infiltration of hyaluronic acid vs placebo
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.
Time frame
From enrollment to the end of treatment after 6 monthsSponsors and contacts
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Source ClinicalTrials.gov