Xerostomia Due to Hyposecretion of Salivary GlandPhase 1/2NCT07309588
Hyaluronic Acid in the Treatment of Hyposalivation
A Phase 1/2 study testing Sunecos-200 Injectable Hyaluronic acid and amino acids solution in people with Xerostomia Due to Hyposecretion of Salivary Gland, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 38 to 78 years
- Conditions the study is for
- Xerostomia Due to Hyposecretion of Salivary Gland
- What is being tested?
- Sunecos-200 Injectable Hyaluronic acid and amino acids solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2025to 19 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- smoking,
- alkohol drinking,
- pregnancy,
- breast feeding,
- diabetes,
- immunosuppressive treatment,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Department of Periodontology and Oral Mucosa Diseases, Poznan University of Medical Sciences
Poznan, Greater Poland Voivodeship, 60-812
About this study
Official title: Hyposalivation Treatment With Non-crosslinked Hyaluronic Acid and Amino Acids Solution
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Sunecos-200 Injectable Hyaluronic acid and amino acids solution
- Keywords
- hyaluronic acid, amino acids, dry mouth
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunecos-200 Injectable Hyaluronic acid and amino acids solutionCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group with intervention of Sunecos-200; injectable HA and AA solution | Experimental | 50 patients (age 38-78) with hyposalivation and syptoms of dry mouth were randomly selected, and the treatment protocol was applied. Exclusion criteria: smoking, pregnancy, breast feeding, diabetes, immunosuppressive treatment and neoplastic diseases. Sjögren disease and active inflammation in the oral cavity were also ruled out.
In the study group Sunecos-200; HA and AAs solution were used as an intervention four times in 2 weeks intervals. At the beginning (qualification visit) and the end of study (2 weeks after the last intervention) the patients completed auctorial questionnaire. The pain level was measured with VAS scale. Patients also completed ( on the qualification and final visit) intraoral examination, including a "mirror test" to evaluate unstimulated saliva flow. To evaluate both unstimulated and stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used.
Patients were asked to not change hygienic protocol and not use a saliva stimulants. Receives: Combination Product: Sunecos-200 Injectable Hyaluronic acid and amino acids solution |
| Control group without intervention | No intervention | 50 patients (age 38-78) with hyposalivation and syptoms of dry mouth were randomly selected as a control group. Exclusion criteria: smoking, pregnancy, breast feeding, diabetes, immunosuppressive treatment and neoplastic diseases. Sjögren disease and active inflammation in the oral cavity were also ruled out.At the beginning (qualification visit) and the end of study (2 weeks after the last intervention in study group with intervention) the patients completed auctorial questionnaire. The pain level was measured with VAS scale. Patients also completed (on the qualification and final visit) intraoral examination, including a "mirror test" to evaluate unstimulated saliva flow. To evaluate both unstimulated and stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used. Patients were asked to not change hygienic protocol and discontinue the use of saliva stimulants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)
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.
Measured: Baseline
Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)
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.
Measured: 8 weeks following the baseline
Improvement in patients-reported oral dryness score using an auctorial questioner
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.
Measured: Baseline
Improvement in patients-reported oral dryness score using an auctorial questioner
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.
Measured: 8 weeks following the baseline.
Secondary outcomes (10)
Changes in unstimulated saliva before HA and AAs injections - mirror test
A "mirror test" evaluates unstimulated saliva flow. The examination checks the mobility of dental mirror on chick's mucous membrane. The results were described as movable or unmovable dental mirror.
Measured: Baseline
Changes in unstimulated saliva after HA and AAs injections - mirror test.
A "mirror test" evaluates unstimulated saliva flow. The examination checks the mobility of dental mirror on chick's mocus membrane. The results were described as movable or unmovable dental mirror.
Measured: 8 weeks following the baseline
Consistency changes in unstimulated saliva before HA and AAs injections.
To evaluate unstimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used. The consistency of unstimulated saliva was assessed visually by the same dentist. The consistency was described as watery, sticky or frothy according to instruction of a Saliva-Check Buffer GC test kit.
Measured: Baseline
Consistency changes in unstimulated saliva after HA and AAs injections.
To evaluate unstimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used. The consistency of unstimulated saliva was assessed visually by the same dentist. The consistency was described as watery, sticky or frothy according to instruction of a Saliva-Check Buffer GC test kit.
Measured: 8 weeks following the baseline
pH changes in unstimulated saliva before HA and AAs injections.
To evaluate unstimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used.
The pH measurement was performed by placing a pH test strip in a sample of unstimulated saliva for 10 s and comparing the results with the test chart included in the package. The samples were divided into strongly acidic (pH 5.0-5.8), moderately acidic (pH 6.0-6.6) and healthy saliva (pH 6.8-7.8) groups.
Measured: Baseline
pH changes in unstimulated saliva after HA and AAs injections.
To evaluate unstimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used.
The pH measurement was performed by placing a pH test strip in a sample of unstimulated saliva for 10 s and comparing the results with the test chart included in the package. The samples were divided into strongly acidic (pH 5.0-5.8), moderately acidic (pH 6.0-6.6) and healthy saliva (pH 6.8-7.8) groups.
Measured: 8 weeks following the baseline
Quantity of saliva changes in stimulated saliva before HA and AAs injections.
To evaluate stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used.
The quantity test of stimulated saliva was performed. The patient was instructed to chew a piece of wax to stimulate saliva production. for 5 minutes. Saliva volume was measured by checking the ml markings on the container wall.
Measured: Baseline
Quantity of saliva changes in stimulated saliva after HA and AAs injections.
To evaluate stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used.
The quantity test of stimulated saliva was performed. The patient was instructed to chew a piece of wax to stimulate saliva production. for 5 minutes. Saliva volume was measured by checking the ml markings on the container wall.
Measured: 8 weeks following the baseline
Buffering capacity changes in stimulated saliva before HA and AAs injections.
To evaluate stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used.
The buffering capacity test of stimulated saliva was performed. The test strip included in the test kit was used to test buffering capacity. The result was calculated after 2 minutes according to the conversion table provided in the kit.
Measured: Baseline
Buffering capacity changes in stimulated saliva after HA and AAs injections.
To evaluate stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used.
The buffering capacity test of stimulated saliva was performed. The test strip included in the test kit was used to test buffering capacity. The result was calculated after 2 minutes according to the conversion table provided in the kit.
Measured: 8 weeks following the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jul 2025
- Primary completion19 Dec 2025 (estimated)
- Study completion19 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Xerostomia Due to Hyposecretion of Salivary GlandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical investigation for new indication of medical device. In this protocol the investigators use medical device class III, not a registerd drug. Study Model: Interventional, Open-label, Controlled
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marzena Liliana Wyganowska, Professor, Study director, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309588
- Sponsor's protocol ID
- PUMS-Hyposalivation-2025-01
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underline the results reported in this clinical trial will be made available upon reasonable request.
Publications
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.
PubMed 42355415
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyposalivation Treatment With Non-crosslinked Hyaluronic Acid and Amino Acids Solution
- ClinicalTrials.gov ID
- NCT07309588
- Acronym / sponsor ID
- PUMS-Hyposalivation-2025-01
- Keywords
- hyaluronic acid, amino acids, dry mouth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 19 Dec 2025 (estimated)
- Study completion
- 19 Jan 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical investigation for new indication of medical device. In this protocol the investigators use medical device class III, not a registerd drug. Study Model: Interventional, Open-label, Controlled
| Arm | Type | Receives |
|---|---|---|
| Study group with intervention of Sunecos-200; injectable HA and AA solution | Experimental | Combination Product: Sunecos-200 Injectable Hyaluronic acid and amino acids solution50 patients (age 38-78) with hyposalivation and syptoms of dry mouth were randomly selected, and the treatment protocol was applied. Exclusion criteria: smoking, pregnancy, breast feeding, diabetes, immunosuppressive treatment and neoplastic diseases. Sjögren disease and active inflammation in the oral cavity were also ruled out. In the study group Sunecos-200; HA and AAs solution were used as an intervention four times in 2 weeks intervals. At the beginning (qualification visit) and the end of study (2 weeks after the last intervention) the patients completed auctorial questionnaire. The pain level was measured with VAS scale. Patients also completed ( on the qualification and final visit) intraoral examination, including a "mirror test" to evaluate unstimulated saliva flow. To evaluate both unstimulated and stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used. Patients were asked to not change hygienic protocol and not use a saliva stimulants. |
| Control group without intervention | No intervention | –50 patients (age 38-78) with hyposalivation and syptoms of dry mouth were randomly selected as a control group. Exclusion criteria: smoking, pregnancy, breast feeding, diabetes, immunosuppressive treatment and neoplastic diseases. Sjögren disease and active inflammation in the oral cavity were also ruled out.At the beginning (qualification visit) and the end of study (2 weeks after the last intervention in study group with intervention) the patients completed auctorial questionnaire. The pain level was measured with VAS scale. Patients also completed (on the qualification and final visit) intraoral examination, including a "mirror test" to evaluate unstimulated saliva flow. To evaluate both unstimulated and stimulated saliva characteristic, a Saliva-Check Buffer GC test kit was used. Patients were asked to not change hygienic protocol and discontinue the use of saliva stimulants. |
Who may qualify
- Ages
- 38 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- smoking,
- alkohol drinking,
- pregnancy,
- breast feeding,
- diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunecos-200 Injectable Hyaluronic acid and amino acids solutionIn 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. | Combination product | Study group with intervention of Sunecos-200; injectable HA and AA solution |
Primary outcome
Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)
Time frame: 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.
Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS)
Time frame: 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
Time frame: 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.
Improvement in patients-reported oral dryness score using an auctorial questioner
Time frame: 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.
10 secondary outcomes
Changes in unstimulated saliva before HA and AAs injections - mirror test
Time frame: Baseline
Changes in unstimulated saliva after HA and AAs injections - mirror test.
Time frame: 8 weeks following the baseline
Consistency changes in unstimulated saliva before HA and AAs injections.
Time frame: Baseline
Consistency changes in unstimulated saliva after HA and AAs injections.
Time frame: 8 weeks following the baseline
pH changes in unstimulated saliva before HA and AAs injections.
Time frame: Baseline
pH changes in unstimulated saliva after HA and AAs injections.
Time frame: 8 weeks following the baseline
Quantity of saliva changes in stimulated saliva before HA and AAs injections.
Time frame: Baseline
Quantity of saliva changes in stimulated saliva after HA and AAs injections.
Time frame: 8 weeks following the baseline
Buffering capacity changes in stimulated saliva before HA and AAs injections.
Time frame: Baseline
Buffering capacity changes in stimulated saliva after HA and AAs injections.
Time frame: 8 weeks following the baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 42355415Wyganowska 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underline the results reported in this clinical trial will be made available upon reasonable request.
Related trials for Xerostomia Due to Hyposecretion of Salivary Gland
Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
Xerostomia Due to Radiotherapy (Disorder)
Active, not recruitingPhase 3
Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine
Xerostomia
Not yet recruitingPhase 2
Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
Xerostomia Due to Hyposecretion of Salivary Gland, Xerostomia Due to Radiotherapy
RecruitingPhase 1/2
Intraglandular Treatment With Adipose-derived Mesenchymal Stem Cells in Patients With Xerostomia Due to Sjögren's Disease
Sjorgren's Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marzena Liliana Wyganowska, Professor study director
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sunecos-200 Injectable Hyaluronic acid and amino acids solution in people with Xerostomia Due to Hyposecretion of Salivary Gland, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported pain connected with oral dryness using Visual Analog Scale (VAS) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07309588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.