Hyposalivation Treatment With Non-crosslinked Hyaluronic Acid and Amino Acids Solution
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 38 Years 至 78 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)
时间窗: Baseline
The Visual Analogue Scale (VAS) assess the pain intensity on a scale from 0 to 10, where 0 indicates no pain; 1-3 - indicates mild pain; 4-6 - indicates moderate pain; 7-9 - indicates severe pain; and 10 - indicates unbearable pain.
Improvement in patients-reported oral dryness score using an auctorial questioner
时间窗: Baseline
The auctorial questioner conteins 10 questions based on Xerostomia Inventory test. The 5 stages Likert scale is used for answer: 1-never, 2-rarely, 3-sometimes, 4-often, 5-always. The score 11-20 means mild dryness; 21-35 means moderate dryness; 36-50 severe dryness. The change of 5 points or more in the score is considered a clinically significant outcome, indicatig the success of treatment.
Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)
时间窗: 8 weeks following the baseline
The Visual Analogue Scale (VAS) assess the pain intensity on a scale from 0 to 10, where 0 indicates no pain; 1-3 - indicates mild pain; 4-6 - indicates moderate pain; 7-9 - indicates severe pain; and 10 - indicates unbearable pain.
Improvement in patients-reported oral dryness score using an auctorial questioner
时间窗: 8 weeks following the baseline.
The auctorial questioner conteins 10 questions based on Xerostomia Inventory test. The 5 stages Likert scale is used for answer: 1-never, 2-rarely, 3-sometimes, 4-often, 5-always. The score 11-20 means mild dryness; 21-35 means moderate dryness; 36-50 severe dryness. The change of 5 points or more in the score is considered a clinically significant outcome, indicatig the success of treatment.
次要结局
- Changes in unstimulated saliva before HA and AAs injections - mirror test(Baseline)
- Changes in unstimulated saliva after HA and AAs injections - mirror test.(8 weeks following the baseline)
- Consistency changes in unstimulated saliva before HA and AAs injections.(Baseline)
- Consistency changes in unstimulated saliva after HA and AAs injections.(8 weeks following the baseline)
- pH changes in unstimulated saliva before HA and AAs injections.(Baseline)
- pH changes in unstimulated saliva after HA and AAs injections.(8 weeks following the baseline)
- Quantity of saliva changes in stimulated saliva before HA and AAs injections.(Baseline)
- Quantity of saliva changes in stimulated saliva after HA and AAs injections.(8 weeks following the baseline)
- Buffering capacity changes in stimulated saliva before HA and AAs injections.(Baseline)
- Buffering capacity changes in stimulated saliva after HA and AAs injections.(8 weeks following the baseline)
