Sjögren's SyndromeSSNCT05680064
The Effect of Chewing Gum, Exercises of the Tongue, Lip, Jaw on Salivation, Xerostomia, Dysphagia in Sjögren's Syndrome
A study testing Tongue, lip, chin exercise group in people with Sjögren's Syndrome and Xerostomia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Sjögren's syndrome (SS) is a chronic, systemic and autoimmune disease characterized by inflammation, fibrosis and dysfunction of exocrine glands such as tear and salivary glands. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sjögren's Syndrome, Xerostomia, Dysphagia
- What is being tested?
- Tongue, lip, chin exercise group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2023to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed as SS according to the 2002 American and European Consensus Group SS classification criteria
- Experiencing xerostomia and dysphagia
- Being between the ages of 18-65
- Not using a total denture
- Not having any other serious illness that will cause dry mouth and dysphagia
- Not having difficulty in chewing and tongue, lip, jaw movement
- Have been receiving treatment for SS for at least 3 months
- To be able to continue working physically and mentally
Who cannot join
- Not wanting to participate in the study
- Wanting to leave work voluntarily
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chewing Gum and Exercises of the Tongue, Lip, and Jaw on Salivation, Xerostomia, and Dysphagia in Patients With Sjögren's Syndrome
Sjögren's syndrome (SS) is a chronic, systemic and autoimmune disease characterized by inflammation, fibrosis and dysfunction of exocrine glands such as tear and salivary glands. SS is defined as primary SS when it progresses alone without any other rheumatic disease finding, while the definition of secondary SS is used in the presence of another accompanying autoimmune disease. One of the most disturbing symptoms of SS is hyposalivation, xerostomia and dysphagia due to hypofunction of salivary glands. While xerostomia is the patient's subjective perception of dry mouth, hyposalivation is also evaluated objectively by salivary flow rate measurement methods. Studies have reported that 0.9% to 64.8% of patients with SS experience xerostomia and 32% to 72% of them experience dysphagia. It was planned as a randomized controlled study to examine its effect on dysphagia.
Read the detailed description
Sjögren's syndrome (SS) is a chronic, systemic and autoimmune disease characterized by inflammation, fibrosis, and dysfunction of exocrine glands such as tear and salivary glands. One of the most disturbing symptoms of SS is hyposalivation, xerostomia, and dysphagia due to the hypofunction of salivary glands. While xerostomia is the patient's subjective perception of dry mouth, hyposalivation is also evaluated objectively by salivary flow rate measurement methods (Pinto, 2021). Studies have reported that 0.9% to 64.8% of patients with SS experience xerostomia and 32% to 72% of them experience dysphagia (Orellana et al, 2016).
With the reduction of saliva, patients may experience difficulties in tasting, chewing, swallowing, speaking, and using prosthesis in patients using prostheses (Pinto, 2021). All these negatively affect the quality of life in patients with SS and their treatment is of great importance (Milin et al, 2016; Pinto, 2021). The treatment of dry mouth in patients with SS consists of pharmacological and non-pharmacological stimulation of the salivary glands and the use of artificial saliva preparations (Ramos_casals et al, 2020). Pharmacological methods used in patients with SS have been shown to reduce dry mouth, but these methods are mostly recommended in severe cases (Ramos_casals et al, 2020; Depinoy et al, 2021). In cases where pharmacological methods are not used, non-pharmacological methods such as taste stimulation (lozenge) and mechanical stimulation (gum) are also recommended in the control of dry mouth (Ramos_casals et al., 2020). It is known that chewing gum increases saliva secretion in studies conducted for different patient groups. used in the treatment of xerostomia in patients with SS, but no study has been found examining the relationship between chewing gum and salivation, xerostomia, and dysphagia in patients with SS (Ramos_casals et al, 2020). In the literature review, no study was found in which the effects of the tongue, lip, and jaw exercises on salivation, xerostomia, and dysphagia were evaluated in any patient group. This study was planned to examine the effects of chewing gum and tongue, lip, and jaw exercises on salivation, xerostomia, and dysphagia in patients with SS.
- Conditions
- Sjögren's Syndrome, Xerostomia, Dysphagia, Salivary Flow Rate
- Being tested
- Tongue, lip, chin exercise group
- Keywords
- Xerostomia,Hyposalivation,Mouth Dryness,Sjögren's syndrome
- Medical subject headings
- Sjogren's Syndrome, Xerostomia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue, lip, chin exercise groupBehavioural
Also called gum chewing group
In order to evaluate the effect of chewing gum and tongue, lip and chin exercises on salivary flow rate, xerostomia and dysphagia, both intervention groups will work in a determined time frame daily.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients who are routinely followed up will be included in the control group. At the end of 15 days, all patients will come to the second interview. The same data collection methods will be repeated after 15 days. |
| Gum-Chewing Group | Experimental | In the gum-chewing group, routine follow-up and additional gum-chewing training will be given (at least 10 minutes 4 times a day, preferably before meals and with sugar-free gum). Patients in the Gum Chewing Group will chew gum as recommended for 15 days. At the end of 15 days, all patients will come to the second interview. The same data collection methods will be repeated after 15 days. In the study, the chewing gum group will chew Vivident Xylit Full Fresh Mint Flavored Liquid Filled Sugar-Free Sweetener Gum. The contents of the gum; Sweeteners (Xylitol, Sorbitols, Mannitol, Maltitols, Aspartame, Acesulfame-K), Gum Yeast, Stabilizer (Glycerol), Flavorings, Natural Mint Flavoring, Maltodextrin, Starch, Emulsifiers (E473, Soy Lecithin), Green Tea Extract, Consistency Enhancers (Cellulose Gum, Xanthan Gum), Coconut Oil, Antioxidant (E321), Brightener (Carnauba Wax), Colorant (E133). There is no allergen warning. Receives: Behavioral: Tongue, lip, chin exercise group |
| Tongue, lip, chin exercise group | Experimental | In the tongue, lip and chin exercise group, patients who are routinely followed up and who will be given additional tongue, lip and jaw exercises training (at least 10 minutes 4 times a day and preferably before meals) will take place. Patients in Tongue, Lip, Chin Exercise Group will do the tongue, lip and chin exercises as recommended for 15 days. At the end of 15 days, all patients will come the second interview. The same data collection methods are repeated after 15 days. content of the training to be given to the tongue, lip and chin exercise group and the exercise brochure to be given to the patients T.C. Oral-Motor Exercises Brochure published by the Ministry of Health Istanbul Provincial Health Directorate, Basic Evaluation Principles in Treatment Movements book and Specialist. It was determined and prepared in line with the recommendations of physiotherapist İbrahim ÖZDEMİR. Receives: Behavioral: Tongue, lip, chin exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulated and Unsimulated Salivary Flow Rate
Unstimulated Salivary Flow Rate: The patient will be placed in the Fawler position. Individuals will be asked to spit into the graduated tube for 5 minutes to collect saliva samples. The amount of saliva accumulated in the tube will be divided by 5 and the amount of saliva per minute (ml/min) will be calculated.
Stimulated Salivary Flow Rate: The patient will be placed in the fawler position. Warning for collection of saliva samples will be provided with sugar-free gum. Individuals will be asked to hold the gum in their mouth until it becomes soft, chew for a few seconds, and swallow the first saliva formed. Then, they will be asked to continue the chewing movement using both sides of the jaw for 5 minutes and spit the saliva formed into the graduated tube at short intervals. The salivary flow rate will be calculated as ml/min by dividing the amount of saliva obtained after 5 minutes of chewing by the time.
Measured: At the first interview, stimulated and unstimulated salivary flow rate of the patients will be measured. In the second interview after 15 days, stimulated and unstimulated salivary flow rate will be measured to observe the change in salivary flow rate.
Secondary outcomes (3)
Xerostomia
Xerostomia is the patient's subjective perception of dry mouth. The Xerostomia Inventory 11 will be used to evaluate xerostomia. Each item describing the symptoms will be marked between 1 and 5 points according to the degree of severity. The result is an overall score ranging from 11 to 55 points. A higher total score indicates more severe symptoms are present.
Measured: It will be measured 2 times with a scale, with an interval of 15 days.
Oral health-related quality of life
It is the effect of diseases, deficiencies and inadequacies related to oral and dental health on the quality of life. Oral Health Impact Profile will be used. Items will be answered with points between 0 and 4. The lowest possible score is 0, while the highest score is 56. A high total score indicates a poor oral and dental health-related quality of life.
Measured: It will be measured 2 times with a scale, with an interval of 15 days.
Dysphagia
It is a disorder in which swallowing time is prolonged and more force is used to swallow than normal. The Eating Assessment Tool is used to evaluate dysphagia symptom severity and response to treatment. Each item is scored from 0 to 4. The total score ranges from 0 to 40. A score approaching 0 in the questionnaire indicates that the severity of the swallowing disorder decreases, and a score closer to 40 indicates that the severity of the swallowing disorder increases.
Measured: It will be measured 2 times with a scale, with an interval of 15 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start10 Jan 2023
- Primary completion1 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental research
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicdan İtişgen, Saglik Bilimleri Universitesi
- Investigators
- Fatma I CINAR, Prof, Principal investigator, Saglik Bilimleri UniversitesiMuhammet CINAR, Prof, Study director, Saglik Bilimleri UniversitesiVicdan ITISGEN, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680064
- Sponsor's protocol ID
- 2022/92
- Acronym
- SS
- Status last verified
- Jul 2023
- First submitted
- 4 Dec 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basakci Calik B, Gur Kabul E, Keskin A, Bozcuk S, Senol H, Cobankara V. Translation and validation of a Turkish version of the Xerostomia Inventory XI in patients with primary Sjogren's syndrome. Turk J Med Sci. 2021 Oct 21;51(5):2477-2484. doi: 10.3906/sag-2005-157.
PubMed 34165270Başol ME, Karaağaçlıoğlu L, Yılmaz B. Türkçe Ağız Sağlığı Etki Ölçeğinin Geliştirilmesi OHIP-14-TR. Turkiye Klinikleri J Dental Sci. 2014; 20: 85-92.
Dalkılıç E, Coşkun BN. Sjögren Sendromunda Sinir Sistemi Tutulumu ve Vaskülit. RAED Dergisi. 2014; 6(2):62-66.
Demir N, Serel Arslan S, Inal O, Karaduman AA. Reliability and Validity of the Turkish Eating Assessment Tool (T-EAT-10). Dysphagia. 2016 Oct;31(5):644-9. doi: 10.1007/s00455-016-9723-9. Epub 2016 Jul 12.
PubMed 27405421Depinoy T, Saraux A, Pers JO, Boisrame S, Cornec D, Marhadour T, Guellec D, Devauchelle-Pensec V, Bressollette L, Jousse-Joulin S. Salivary Glands and Periodontal Changes in a Population of Sjogren's and Sicca Syndrome Treated by Pilocarpine: A Pilot Study. Rheumatol Ther. 2021 Mar;8(1):219-231. doi: 10.1007/s40744-020-00263-y. Epub 2020 Dec 17.
PubMed 33336287Lopez-Pintor RM, Ramirez L, Serrano J, de Pedro M, Fernandez-Castro M, Casanas E, Hernandez G. Effects of Xerostom(R) products on xerostomia in primary Sjogren's syndrome: A randomized clinical trial. Oral Dis. 2019 Apr;25(3):772-780. doi: 10.1111/odi.13019. Epub 2019 Jan 8.
PubMed 30561129Milin M, Cornec D, Chastaing M, Griner V, Berrouiguet S, Nowak E, Marhadour T, Saraux A, Devauchelle-Pensec V. Sicca symptoms are associated with similar fatigue, anxiety, depression, and quality-of-life impairments in patients with and without primary Sjogren's syndrome. Joint Bone Spine. 2016 Dec;83(6):681-685. doi: 10.1016/j.jbspin.2015.10.005. Epub 2016 Jan 13.
PubMed 26774177Mumcu G, Bıçakçıgil M, Cimilli H, Toker, E, Atalay T, Yavuz Ş. Sjögren Sendromlu Hastalarda Ağız Sağlığının Değerlendirilmesi-Pilot Çalışma. EÜ Diş Hek Fak Derg. 2006; 27:39-44.
Orellana MF, Lagravere MO, Boychuk DG, Major PW, Flores-Mir C. Prevalence of xerostomia in population-based samples: a systematic review. J Public Health Dent. 2006 Spring;66(2):152-8. doi: 10.1111/j.1752-7325.2006.tb02572.x.
PubMed 16711637Pinto A. Management of xerostomia and other complications of Sjogren's syndrome. Oral Maxillofac Surg Clin North Am. 2014 Feb;26(1):63-73. doi: 10.1016/j.coms.2013.09.010.
PubMed 24287194Ramos-Casals M, Brito-Zeron P, Bombardieri S, Bootsma H, De Vita S, Dorner T, Fisher BA, Gottenberg JE, Hernandez-Molina G, Kocher A, Kostov B, Kruize AA, Mandl T, Ng WF, Retamozo S, Seror R, Shoenfeld Y, Siso-Almirall A, Tzioufas AG, Vitali C, Bowman S, Mariette X; EULAR-Sjogren Syndrome Task Force Group. EULAR recommendations for the management of Sjogren's syndrome with topical and systemic therapies. Ann Rheum Dis. 2020 Jan;79(1):3-18. doi: 10.1136/annrheumdis-2019-216114. Epub 2019 Oct 31.
PubMed 31672775
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chewing Gum and Exercises of the Tongue, Lip, and Jaw on Salivation, Xerostomia, and Dysphagia in Patients With Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT05680064
- Acronym / sponsor ID
- SS / 2022/92
- Conditions
- Sjögren's Syndrome, Xerostomia, Dysphagia, Salivary Flow Rate
- Keywords
- Xerostomia,Hyposalivation,Mouth Dryness,Sjögren's syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 11 Jan 2023 (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.
Sjögren's syndrome (SS) is a chronic, systemic and autoimmune disease characterized by inflammation, fibrosis and dysfunction of exocrine glands such as tear and salivary glands. SS is defined as primary SS when it progresses alone without any other rheumatic disease finding, while the definition of secondary SS is used in the presence of another accompanying autoimmune disease. One of the most disturbing symptoms of SS is hyposalivation, xerostomia and dysphagia due to hypofunction of salivary glands. While xerostomia is the patient's subjective perception of dry mouth, hyposalivation is also evaluated objectively by salivary flow rate measurement methods. Studies have reported that 0.9% to 64.8% of patients with SS experience xerostomia and 32% to 72% of them experience dysphagia. It was planned as a randomized controlled study to examine its effect on dysphagia.
Detailed description
Sjögren's syndrome (SS) is a chronic, systemic and autoimmune disease characterized by inflammation, fibrosis, and dysfunction of exocrine glands such as tear and salivary glands. One of the most disturbing symptoms of SS is hyposalivation, xerostomia, and dysphagia due to the hypofunction of salivary glands. While xerostomia is the patient's subjective perception of dry mouth, hyposalivation is also evaluated objectively by salivary flow rate measurement methods (Pinto, 2021). Studies have reported that 0.9% to 64.8% of patients with SS experience xerostomia and 32% to 72% of them experience dysphagia (Orellana et al, 2016).
With the reduction of saliva, patients may experience difficulties in tasting, chewing, swallowing, speaking, and using prosthesis in patients using prostheses (Pinto, 2021). All these negatively affect the quality of life in patients with SS and their treatment is of great importance (Milin et al, 2016; Pinto, 2021). The treatment of dry mouth in patients with SS consists of pharmacological and non-pharmacological stimulation of the salivary glands and the use of artificial saliva preparations (Ramos_casals et al, 2020). Pharmacological methods used in patients with SS have been shown to reduce dry mouth, but these methods are mostly recommended in severe cases (Ramos_casals et al, 2020; Depinoy et al, 2021). In cases where pharmacological methods are not used, non-pharmacological methods such as taste stimulation (lozenge) and mechanical stimulation (gum) are also recommended in the control of dry mouth (Ramos_casals et al., 2020). It is known that chewing gum increases saliva secretion in studies conducted for different patient groups. used in the treatment of xerostomia in patients with SS, but no study has been found examining the relationship between chewing gum and salivation, xerostomia, and dysphagia in patients with SS (Ramos_casals et al, 2020). In the literature review, no study was found in which the effects of the tongue, lip, and jaw exercises on salivation, xerostomia, and dysphagia were evaluated in any patient group. This study was planned to examine the effects of chewing gum and tongue, lip, and jaw exercises on salivation, xerostomia, and dysphagia in patients with SS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- experimental research
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients who are routinely followed up will be included in the control group. At the end of 15 days, all patients will come to the second interview. The same data collection methods will be repeated after 15 days. |
| Gum-Chewing Group | Experimental | Behavioral: Tongue, lip, chin exercise groupIn the gum-chewing group, routine follow-up and additional gum-chewing training will be given (at least 10 minutes 4 times a day, preferably before meals and with sugar-free gum). Patients in the Gum Chewing Group will chew gum as recommended for 15 days. At the end of 15 days, all patients will come to the second interview. The same data collection methods will be repeated after 15 days. In the study, the chewing gum group will chew Vivident Xylit Full Fresh Mint Flavored Liquid Filled Sugar-Free Sweetener Gum. The contents of the gum; Sweeteners (Xylitol, Sorbitols, Mannitol, Maltitols, Aspartame, Acesulfame-K), Gum Yeast, Stabilizer (Glycerol), Flavorings, Natural Mint Flavoring, Maltodextrin, Starch, Emulsifiers (E473, Soy Lecithin), Green Tea Extract, Consistency Enhancers (Cellulose Gum, Xanthan Gum), Coconut Oil, Antioxidant (E321), Brightener (Carnauba Wax), Colorant (E133). There is no allergen warning. |
| Tongue, lip, chin exercise group | Experimental | Behavioral: Tongue, lip, chin exercise groupIn the tongue, lip and chin exercise group, patients who are routinely followed up and who will be given additional tongue, lip and jaw exercises training (at least 10 minutes 4 times a day and preferably before meals) will take place. Patients in Tongue, Lip, Chin Exercise Group will do the tongue, lip and chin exercises as recommended for 15 days. At the end of 15 days, all patients will come the second interview. The same data collection methods are repeated after 15 days. content of the training to be given to the tongue, lip and chin exercise group and the exercise brochure to be given to the patients T.C. Oral-Motor Exercises Brochure published by the Ministry of Health Istanbul Provincial Health Directorate, Basic Evaluation Principles in Treatment Movements book and Specialist. It was determined and prepared in line with the recommendations of physiotherapist İbrahim ÖZDEMİR. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be diagnosed as SS according to the 2002 American and European Consensus Group SS classification criteria
- Experiencing xerostomia and dysphagia
- Being between the ages of 18-65
- Not using a total denture
- Not having any other serious illness that will cause dry mouth and dysphagia
Key exclusion criteria (2 listed)
- Not wanting to participate in the study
- Wanting to leave work voluntarily
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 |
|---|---|---|
| Tongue, lip, chin exercise groupAlso: gum chewing groupIn order to evaluate the effect of chewing gum and tongue, lip and chin exercises on salivary flow rate, xerostomia and dysphagia, both intervention groups will work in a determined time frame daily. | Behavioural | Gum-Chewing Group, Tongue, lip, chin exercise group |
Primary outcome
Simulated and Unsimulated Salivary Flow Rate
Time frame: At the first interview, stimulated and unstimulated salivary flow rate of the patients will be measured. In the second interview after 15 days, stimulated and unstimulated salivary flow rate will be measured to observe the change in salivary flow rate.
Unstimulated Salivary Flow Rate: The patient will be placed in the Fawler position. Individuals will be asked to spit into the graduated tube for 5 minutes to collect saliva samples. The amount of saliva accumulated in the tube will be divided by 5 and the amount of saliva per minute (ml/min) will be calculated. Stimulated Salivary Flow Rate: The patient will be placed in the fawler position. Warning for collection of saliva samples will be provided with sugar-free gum. Individuals will be asked to hold the gum in their mouth until it becomes soft, chew for a few seconds, and swallow the first saliva formed. Then, they will be asked to continue the chewing movement using both sides of the jaw for 5 minutes and spit the saliva formed into the graduated tube at short intervals. The salivary flow rate will be calculated as ml/min by dividing the amount of saliva obtained after 5 minutes of chewing by the time.
3 secondary outcomes
Xerostomia
Time frame: It will be measured 2 times with a scale, with an interval of 15 days.
Oral health-related quality of life
Time frame: It will be measured 2 times with a scale, with an interval of 15 days.
Dysphagia
Time frame: It will be measured 2 times with a scale, with an interval of 15 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 34165270Basakci Calik B, Gur Kabul E, Keskin A, Bozcuk S, Senol H, Cobankara V. Translation and validation of a Turkish version of the Xerostomia Inventory XI in patients with primary Sjogren's syndrome. Turk J Med Sci. 2021 Oct 21;51(5):2477-2484. doi: 10.3906/sag-2005-157.
- BackgroundBaşol ME, Karaağaçlıoğlu L, Yılmaz B. Türkçe Ağız Sağlığı Etki Ölçeğinin Geliştirilmesi OHIP-14-TR. Turkiye Klinikleri J Dental Sci. 2014; 20: 85-92.
- BackgroundDalkılıç E, Coşkun BN. Sjögren Sendromunda Sinir Sistemi Tutulumu ve Vaskülit. RAED Dergisi. 2014; 6(2):62-66.
- Background: PubMed 27405421Demir N, Serel Arslan S, Inal O, Karaduman AA. Reliability and Validity of the Turkish Eating Assessment Tool (T-EAT-10). Dysphagia. 2016 Oct;31(5):644-9. doi: 10.1007/s00455-016-9723-9. Epub 2016 Jul 12.
- Background: PubMed 33336287Depinoy T, Saraux A, Pers JO, Boisrame S, Cornec D, Marhadour T, Guellec D, Devauchelle-Pensec V, Bressollette L, Jousse-Joulin S. Salivary Glands and Periodontal Changes in a Population of Sjogren's and Sicca Syndrome Treated by Pilocarpine: A Pilot Study. Rheumatol Ther. 2021 Mar;8(1):219-231. doi: 10.1007/s40744-020-00263-y. Epub 2020 Dec 17.
- Background: PubMed 30561129Lopez-Pintor RM, Ramirez L, Serrano J, de Pedro M, Fernandez-Castro M, Casanas E, Hernandez G. Effects of Xerostom(R) products on xerostomia in primary Sjogren's syndrome: A randomized clinical trial. Oral Dis. 2019 Apr;25(3):772-780. doi: 10.1111/odi.13019. Epub 2019 Jan 8.
- Background: PubMed 26774177Milin M, Cornec D, Chastaing M, Griner V, Berrouiguet S, Nowak E, Marhadour T, Saraux A, Devauchelle-Pensec V. Sicca symptoms are associated with similar fatigue, anxiety, depression, and quality-of-life impairments in patients with and without primary Sjogren's syndrome. Joint Bone Spine. 2016 Dec;83(6):681-685. doi: 10.1016/j.jbspin.2015.10.005. Epub 2016 Jan 13.
- BackgroundMumcu G, Bıçakçıgil M, Cimilli H, Toker, E, Atalay T, Yavuz Ş. Sjögren Sendromlu Hastalarda Ağız Sağlığının Değerlendirilmesi-Pilot Çalışma. EÜ Diş Hek Fak Derg. 2006; 27:39-44.
- Background: PubMed 16711637Orellana MF, Lagravere MO, Boychuk DG, Major PW, Flores-Mir C. Prevalence of xerostomia in population-based samples: a systematic review. J Public Health Dent. 2006 Spring;66(2):152-8. doi: 10.1111/j.1752-7325.2006.tb02572.x.
- Background: PubMed 24287194Pinto A. Management of xerostomia and other complications of Sjogren's syndrome. Oral Maxillofac Surg Clin North Am. 2014 Feb;26(1):63-73. doi: 10.1016/j.coms.2013.09.010.
- Background: PubMed 31672775Ramos-Casals M, Brito-Zeron P, Bombardieri S, Bootsma H, De Vita S, Dorner T, Fisher BA, Gottenberg JE, Hernandez-Molina G, Kocher A, Kostov B, Kruize AA, Mandl T, Ng WF, Retamozo S, Seror R, Shoenfeld Y, Siso-Almirall A, Tzioufas AG, Vitali C, Bowman S, Mariette X; EULAR-Sjogren Syndrome Task Force Group. EULAR recommendations for the management of Sjogren's syndrome with topical and systemic therapies. Ann Rheum Dis. 2020 Jan;79(1):3-18. doi: 10.1136/annrheumdis-2019-216114. Epub 2019 Oct 31.
- Individual participant dataSharing planned: No
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Sjögren's Disease
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren'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. This study is not recruiting at the moment.
Fatma I CINAR, Prof principal investigator
Saglik Bilimleri Universitesi
Muhammet CINAR, Prof study director
Saglik Bilimleri Universitesi
Vicdan ITISGEN study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue, lip, chin exercise group in people with Sjögren's Syndrome and Xerostomia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jul 2023. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Simulated and Unsimulated Salivary Flow Rate (time frame: At the first interview, stimulated and unstimulated salivary flow rate of the patients will be measured. In the second interview after 15 days, stimulated and unstimulated salivary flow rate will be measured to observe the change in salivary flow rate.). 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 NCT05680064, which also lists 11 linked publications.
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 20 Jul 2023.