Does Hyaluronic Acid Help Relieve Dry Mouth?
2026年5月13日 更新者：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
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Verónica C Schiavo, DDs, MSc
- 電話番号：0034653515208
- メール：v.schiavo@ub.edu
研究場所
-
-
Barcelona
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Barcelona、Barcelona、スペイン、08907
- 募集
- Hospital Odontologico Universidad de Barcelona
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コンタクト：
- Verónica C Schiavo, DDs, MSc
- 電話番号：0034653515208
- メール：v.schiavo@ub.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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)
|
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プラセボコンパレーター：Saline solution
Submucosal infiltration of placebo (0,9% saline solution)
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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)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Salivary secretion in patients with xerostomia before and after submucosal infiltration of hyaluronic acid or placebo
時間枠：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.
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From enrollment to the end of treatment at 6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of cracks, erosions, and ulcers on the lips and oral mucosa following submucosal infiltration of hyaluronic acid vs placebo
時間枠：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.
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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
時間枠：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
|
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Patient's self reported anxiety status after submucosal infiltration of hyaluronic acid vs placebo
時間枠：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.
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From enrollment to the end of treatment after 6 months
|
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Patient's self reported depressive symptoms after submucosal infiltration of hyaluronic acid vs placebo
時間枠：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
|
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Patient's self reported oral health related quality of life after submucosal infiltration of hyaluronic acid vs placebo
時間枠：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
|
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Presence of oral mucosal pathology in patients diagnosed with xerostomia
時間枠：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
時間枠：From enrollment to the end of treatment at 6 months
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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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：José López, MD, PhD、University of Barcelona
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年11月11日
一次修了 (推定)
2026年11月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年1月11日
QC基準を満たした最初の提出物
2026年5月13日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。