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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid | Experimental | Submucosal infiltration of non reticulated hyaluronic acid |
|
| Saline solution | Placebo Comparator | Submucosal infiltration of placebo (0,9% saline solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Submucosal infiltration of non reticulated hyaluronic acid | Device | Submucosal infiltration of non reticulated hyaluronic acid will be administered all over the buccal cavity (floor of the mouth, yugal mucosa, lips) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronica C Schiavo, DDs, Msc | Contact | 0034653515208 | v.schiavo@ub.edu |
| Name | Affiliation | Role |
|---|---|---|
| José López, MD, PhD | University of Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Odontologico Universidad de Barcelona | Recruiting | Barcelona | Barcelona | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38231354 | Background | 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. | |
| 29733533 | Background | 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. |
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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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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Submucosal infiltration of Placebo | Device | 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) |
|
| From enrollment to the end of treatment at 6 months |
| 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). | From enrollment to the end of treatment at 6 months |
| 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. | From enrollment to the end of treatment after 6 months |
| 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. | 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 | 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 | 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 | 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 |
| 34454465 | Background | 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. |
| 35514082 | Background | 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. |
| 27324942 | Background | 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. |
| 27031061 | Background | 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. |
| 30091142 | Background | 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. |
| 38424432 | Background | Kim YJ. Xerostomia: Advances and Challenges in Drug Development. Curr Drug Targets. 2024;25(5):301-305. doi: 10.2174/0113894501293941240228050343. No abstract available. |