Hyaluronic Acid in the Treatment of Hyposalivation
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Sunecos-200 Injectable Hyaluronic acid and amino acids solution.
- Кому может быть актуально
- Состояния в реестре: Xerostomia Due to Hyposecretion of Salivary Gland. Базовые параметры: 38 лет — 78 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
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- Следующий шаг
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Официальное название
Hyposalivation Treatment With Non-crosslinked Hyaluronic Acid and Amino Acids Solution
Обзор
The goal of this clinical trial is to learn if drug containing non-crosslinked hyaluronic acid and amino acids solution (Sunecos-200) works to treat hyposalivation in adults. It will also learn about the safety of drug Sunecos-200. The main questions it aims to answer are: * Does Sunecos-200 improve the saliva secretion and improve a life comfort? * What medical problems do participants have when taking Sunecos-200? Researchers will compare drug containing non-crosslinked hyaluronic acid and amino acids solution (Sunecos-200) to a control group (without intervention) to see if drug Sunecos-200 works to treat hyposalivation. Participants will: * Take drug Sunecos-200 by into oral mucosa injection or nothing every two weeks for 4 times. * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their symptoms after injection and fill out a primary and final questionary.
Подробное описание
Dry mouth is one of the most common complaints among patients, in both dental and general medicine practices, especially among the older population. Xerostomia (or dry mouth) is a medical term used to describe the subjective sensation of dry mouth that commonly occurs because of decreased salivary flow (hyposalivation). Although the two terms do not correspond to the same conditions and should not be used interchangeably, many physicians do so, since most patients with xerostomia also have hyposalivation.
Approximately 30% of the population complains on some degree of dry mouth. When it happens occasionally, during dehydration or stress, it is not a cause for concern. The situation is more serious if it happens more often, such as every day. It could also point to an underlying health condition. In untreated patients, hyposalivation increase their vulnerability to tooth decay, gingivitis and oral mucosa sensation. Dry mouth is related to pain, sometimes insomnia and psychological problems and results in deterioration of life well-being.
Saliva is produced by major salivary glands (MaSGs), the parotid, submandibular and sublingual glands and by circa 600 to 1,000 minor salivary glands (MiSGs) located in the submucosa layer in the oral cavity. MaSG contributed to 90% of total saliva secretions, whereas MiSG contributed to the remaining 10%. MiSGs are important for preventing the subjective sensation of dry mouth, since the saliva produced by these glands creates a lubricating micron-thick film that protects the oral mucosae. Furthermore, MiSGs play a key role in saliva production during sleep; therefore, reduced MiSG flow appears to be a cause of nocturnal dry mouth.
Saliva is a hypotonic solution composed of 98.5% water with 1% organic and 0.5% inorganic components. The organic and inorganic components of saliva are present in low concentrations, with some proteins synthetized in the gland (such as α-amylase) present in relatively high concentrations. Other organic components detected in saliva are vitamin C, maltase, urea, uric acid, lactase, hormones (testosterone, cortisol), albumin, creatinine, amino acids, mucin and immunoglobulins (IgA, IgG, IgM). Saliva α-amylase and lipase play a role in starch digestion and triglyceride decomposition. Salivary mucins lubricate intraoral structures and help to form a barrier against microbial invasion. Salivary immunoglobulins, especially secretory IgA (SIgA), play a key role in neutralizing toxins, agglutinating bacteria, and preventing their adhesion to mucosal surfaces.
By moistening the oral mucosa, saliva facilitates chewing, swallowing, and speech. Furthermore, a constant flow of saliva facilitates the mechanical removal of food debris and microorganisms and regulates the oral pH, protecting against acidic byproducts of bacterial metabolism. This buffering capacity is essential for maintaining a healthy oral microbiome and preventing demineralization of tooth enamel. Saliva also serves as a protective factor against infections because of its numerous organic components. People with dry mouth not only have trouble chewing and swallowing food but also have difficulty with tasting, speaking, and a reduced tolerance for dentures. Furthermore, xerostomia increases the risk of caries, periodontal disease, candidiasis, oral ulcers, and dysphagia, which can negatively impact nutritional status and quality of life.
There is wide variability in individual salivary flow rates. The average daily flow of whole saliva varies between 0.5 and 1.5 L. The accepted range for normal unstimulated salivary flow is above 0.1 ml/min. Any unstimulated flow rate below 0.1 ml/min is considered hypofunction. Stimulated saliva represents 80 to 90 % of daily salivary production, and the stimulated flow rate varies from 1 to 3 mL/minute.
Several studies have considered changes in saliva quantity and quality throughout the lifetime. No consensus has been reached on the decrease in the salivary flow rate with age. Despite this, recent research by Vandenberghe-Descamps et al revealed a 38.5% reduction in the resting salivary flow rate and 38.0% reduction of stimulated salivary flow rate in elderly subjects compared with young subjects. The cause of salivary flow decline has been connected to the loss of acinar cells; loss of secretory tissue and adiposity increase, as well as neurophysiological deterioration. Additionally, changes in saliva composition with age have been reported in some studies. Most notably, the mucin concentration decreases, which promotes the development of diseases of the oral mucosa and dry mouth.
Given the impact of reduced salivary flow on quality of life and oral health, assessing salivary function should be part of routine dental examinations, especially since saliva sampling is easy and noninvasive. The most advocated clinical method for diagnosing salivary gland dysfunction is to quantify unstimulated and stimulated whole saliva flow rates (sialometry). Recently, the Clinical Dry Mouth Score (CODS) was developed to objectively quantify clinical signs of decreased salivary flow. The CODS aims to provide a quick, easy, and objective method for assessing salivary gland function in a clinical setting. The CODS assesses dry mouth through clinical and visual examination of the oral cavity on the basis of several signs of dryness, such as frothy saliva, dry oral mucosa, and sticking of the mouth mirror to the tongue or cheek fold.
Despite the various etiological factors underlying xerostomia, the available treatment options do not differ on the basis of the cause and are predominantly symptomatic-except in cases of drug-induced xerostomia, where therapy involves discontinuation of the systemic medication.
Therapeutic strategies implemented to manage xerostomia, regardless of its etiology, have thus far failed to yield definitive or consistently effective outcomes.
Вмешательства
- Комбинированный продукт Sunecos-200 Injectable Hyaluronic acid and amino acids solution
In the study group with intervention a total of 2 mL (1 mL on each side) of Sunecos-200 solution (HA and AAs) were injected into the buccal mucosa four times at two-week intervals. The distance between the points of the injections was approximately 10 mm. The total number of injection points per side was 5. Cosmetic syringes (1 ml) and needles 30 G 4 mm were used for injection.
Первичные конечные точки
- Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS) [Срок оценки: Baseline]
- Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS) [Срок оценки: 8 weeks following the baseline]
- Improvement in patients-reported oral dryness score using an auctorial questioner [Срок оценки: Baseline]
- Improvement in patients-reported oral dryness score using an auctorial questioner [Срок оценки: 8 weeks following the baseline.]
Вторичные конечные точки (10)
- Changes in unstimulated saliva before HA and AAs injections - mirror test [Срок оценки: Baseline]
- Changes in unstimulated saliva after HA and AAs injections - mirror test. [Срок оценки: 8 weeks following the baseline]
- Consistency changes in unstimulated saliva before HA and AAs injections. [Срок оценки: Baseline]
- Consistency changes in unstimulated saliva after HA and AAs injections. [Срок оценки: 8 weeks following the baseline]
- pH changes in unstimulated saliva before HA and AAs injections. [Срок оценки: Baseline]
- pH changes in unstimulated saliva after HA and AAs injections. [Срок оценки: 8 weeks following the baseline]
- Quantity of saliva changes in stimulated saliva before HA and AAs injections. [Срок оценки: Baseline]
- Quantity of saliva changes in stimulated saliva after HA and AAs injections. [Срок оценки: 8 weeks following the baseline]
- Buffering capacity changes in stimulated saliva before HA and AAs injections. [Срок оценки: Baseline]
- Buffering capacity changes in stimulated saliva after HA and AAs injections. [Срок оценки: 8 weeks following the baseline]
Критерии участия
Критерии включения
- subjective feeling of dry mouth caused by a lack of saliva for at least 3 month,
- informed consent sing by patient,
- other complains including difficulty during eating, speaking or swallowing, taste disorders, trouble wearing dentures, the sensation that the tongue is stuck to the palate, bad breath and insomnia, feeling dry mouth at night, which made it difficult or impossible to sleep.
Критерии исключения
- smoking,
- alkohol drinking,
- pregnancy,
- breast feeding,
- diabetes,
- immunosuppressive treatment,
- neoplastic diseases,
- Sjögren disease,
- active inflammation in the oral cavity,
- participation in other clinical trial in within the last 3 months,
- allergy or hipersensitivity to hyaluronic acid or amino acides,
- no planned hospital stay during the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Польша · 1 центр
- Department of Periodontology and Oral Mucosa Diseases, Poznan University of Medical Scienc — Poznan
Публикации
- Wyganowska ML, Klewin-Steinbock S, Ao P. Hyposalivation Treatment with Non-Crosslinked Hyaluronic Acid and Amino Acids Solution-A Clinical Pilot Study. Life (Basel). 2026 May 25;16(6):887. doi: 10.3390/life16060887. PMID 42355415
Идентификаторы
NCT: NCT07309588 · PUMS-Hyposalivation-2025-01