Sjogren SyndromeNCT07864987
Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease
A study testing Oral exercise in people with Sjogren Syndrome, run by Nazli Elif Nacar.
Trial summary
Sjögren disease (SjD) is a chronic autoimmune disease in which salivary gland dysfunction commonly causes persistent dry mouth (xerostomia). Although oral dryness is a major and burdensome symptom, evidence for effective non-pharmacological interventions remains limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren Syndrome
- What is being tested?
- Oral exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2026to 30 Sep 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of SjD based on the 2016 ACR/EULAR Classification Criteria;
- ≥18 years of age;
- residual stimulated whole salivary flow rate (≥0.05 ml/min);
- presence of subjective xerostomia (Visual Analogue Scale ≥ 50);
- stable pharmacological treatment for at least 4 weeks before enrolment;
- provision of written informed consent. -
Who cannot join
- history of head and neck radiotherapy,
- severe cognitive impairment (i.e., dementia)
- psychiatric disorders preventing participation,
- neurological disorders affecting oral motor function,
- participation in structured oral motor or swallowing rehabilitation within the previous 2 months,
- inability or unwillingness to comply with the study protocol.
About this study
Official title: Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease: A Randomized Controlled Trial
Sjögren disease (SjD) is a chronic autoimmune disease in which salivary gland dysfunction commonly causes persistent dry mouth (xerostomia). Although oral dryness is a major and burdensome symptom, evidence for effective non-pharmacological interventions remains limited. This randomized controlled trial will investigate whether a structured oral exercise program improves xerostomia in adults with Sjögren disease.
Participants will be randomly allocated to either an intervention group receiving a structured oral exercise program in addition to standardized oral hygiene education and usual medical care, or a control group receiving standardized oral hygiene education and usual medical care alone. The oral exercise program will be performed twice daily for 6 weeks. The primary outcome will be the between-group difference in change in Xerostomia Inventory score from baseline to week 6. Secondary outcomes will include salivary flow, oral health-related quality of life, swallowing symptoms, and perceived dryness. Patient-reported outcomes will also be assessed at week 12 to evaluate maintenance of treatment effects.
Read the detailed description
Sjögren disease (SjD) is a chronic systemic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal gland dysfunction. Dry mouth resulting from salivary gland hypofunction is one of the most common and burdensome manifestations of the disease. Salivary gland hypofunction contributes to chronic xerostomia, impaired oral comfort, difficulties in speaking and swallowing, alterations in taste perception, and reduced oral health-related quality of life.
Although dry mouth has been considered a consequence of immune-mediated salivary gland destruction, accumulating evidence suggests that glandular pathology alone cannot fully explain the severity of symptoms experienced by patients. The degree of exocrine gland destruction correlates only weakly with glandular function, and objective measures of salivary secretion do not consistently correspond with patients' subjective perception of oral dryness. These findings suggest that the symptoms experienced by patients cannot be explained solely by immune-mediated glandular destruction, indicating that additional mechanisms may contribute to xerostomia in SjD.
Current management of xerostomia in SjD includes saliva substitutes, chewing gum, systemic sialogogues, acupuncture, and electrical stimulation. However, current evidence supporting non-pharmacological interventions remains limited, and no specific intervention can currently be recommended with confidence because of the low quality and heterogeneity of the available studies. Consequently, there remains an unmet need for safe, accessible, and evidence-based non-pharmacological interventions for xerostomia in SjD.
Structured oral exercise programs have shown potential benefits for salivary secretion, oral motor function, and xerostomia symptoms in other populations, including older adults and individuals with radiation-induced xerostomia. Repeated oral motor activity may stimulate salivary secretion through mechanical and sensorimotor stimulation of the oral cavity. However, whether structured oral exercises improve xerostomia-related outcomes in patients with SjD remains unknown.
Therefore, the primary aim of this randomized controlled trial is to investigate whether a structured oral exercise programme, in addition to oral hygiene education and usual medical care, reduces xerostomia severity. Secondary aims are to evaluate its effects on salivary flow, oral health-related quality of life, and swallowing symptoms.
- Conditions
- Sjogren Syndrome
- Being tested
- Oral exercise
- Keywords
- sjogren disease, oral exercise, xerostomia, dry mouth
- Medical subject headings
- Sjogren's Syndrome, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral exerciseOther
The oral exercise program will consist of a series of simple oral motor exercises involving coordinated movements of the jaw, lips, cheeks, and tongue. The program was developed based on previously published oral exercise protocols in older adults and patients with xerostomia, with modifications for patients with SjD.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants in the experimental group will subsequently perform the exercises at home twice daily for six weeks. Written instructions and illustrated exercise sheets will be provided to facilitate adherence. The participants will be provided with an exercise diary to record exercise adherence throughout the intervention period. Participants will receive a weekly telephone call from the physiotherapist to encourage adherence and answer any questions regarding the exercise program.
The oral exercise program will consist of a series of simple oral motor exercises involving coordinated movements of the jaw, lips, cheeks, and tongue. Receives: Other: Oral exercise |
| Control group | No intervention | Both groups will receive standardized oral hygiene education. All participants will be instructed to continue their usual medical treatment throughout the study period without changing medication unless clinically indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerostomia Inventory (XI)
The XI is a patient-reported assessment tool designed to evaluate the sensation of dry mouth. It consists of 11 items using a 5-point Likert scale, with each item scored from 1 (never) to 5 (very frequently). The total score ranges from 11 to 55, with higher scores indicating a more severe level of dry mouth.
Measured: baseline, week 6, week 12
Secondary outcomes (7)
EULAR Primary Sjögren's Syndrome Patient-Reported Index (ESSPRI)
ESSPRI was developed to assess-based on patient self-reporting-the symptoms of dryness, fatigue, and pain experienced by individuals with pSS over the preceding two weeks. These three symptoms are evaluated individually, with the severity of each rated on a scale from 0 (absent) to 10 (most severe). Individuals are asked to score the severity of their symptoms within this range. The total score is calculated by averaging the component scores. An ESSPRI score below 5 is considered an acceptable disease state, whereas a score of 5 or higher is regarded as an indication of high disease activity.
Measured: baseline, week 6, week 12
Dryness severity
The severity of perceived mouth, eye, and nose dryness will be assessed using a 100-mm Visual Analogue Scale (VAS); over the preceding two weeks.
Measured: baseline, week 6, week 12
unstimulated whole salivary flow rate
Unstimulated whole saliva will be collected for 5 minutes. Participants will continuously expectorate the accumulated whole saliva into a pre-weighed collection tube without swallowing
Measured: baseline, week 6
stimulated whole salivary flow rate
Stimulated whole saliva will be collected for 5 minutes using a standardised citric acid stimulation procedure. A cotton-tipped applicator soaked in 2% citric acid will be applied to the lateral borders of the tongue at the beginning of the collection and reapplied every 60 seconds. Participants will continuously expectorate the accumulated whole saliva into a pre-weighed collection tube without swallowing
Measured: baseline, immediately post-first exercise session, week 6
Oral Health Impact Profile-14
Oral health will be evaluated with OHIP-14 using a 5-point Likert scale (ranging from "4=very often" to "0=never"). The total score obtained by totaling the item for the 14 items at the same frequency; the total score ranged from 0 to 56.
Measured: baseline, week 6, week 12
Eating Assessment Tool-10
The EAT-10 is a self-report assessment tool used to identify individuals at high risk for swallowing disorders. It consists of 10 items, each scored on a five-point Likert-type scale ranging from 0 (no problem) to 4 (severe problem). A score of three or higher on the EAT-10 indicates the possible presence of dysphagia.
Measured: baseline, week 6, week 12
Global Rating of Change scale
Participants' perceived change in oral dryness will also be evaluated using a Global Rating of Change scale. (much better, a little better, no change, a little worse, much worse).
Measured: week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazli Elif Nacar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazli Elif Nacar, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864987
- Sponsor's protocol ID
- KSU/2026-09
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07864987
- Acronym / sponsor ID
- KSU/2026-09
- Conditions
- Sjogren Syndrome
- Keywords
- sjogren disease, oral exercise, xerostomia, dry mouth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Nazli Elif NacarUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 8 Oct 2026 (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 disease (SjD) is a chronic autoimmune disease in which salivary gland dysfunction commonly causes persistent dry mouth (xerostomia). Although oral dryness is a major and burdensome symptom, evidence for effective non-pharmacological interventions remains limited. This randomized controlled trial will investigate whether a structured oral exercise program improves xerostomia in adults with Sjögren disease.
Participants will be randomly allocated to either an intervention group receiving a structured oral exercise program in addition to standardized oral hygiene education and usual medical care, or a control group receiving standardized oral hygiene education and usual medical care alone. The oral exercise program will be performed twice daily for 6 weeks. The primary outcome will be the between-group difference in change in Xerostomia Inventory score from baseline to week 6. Secondary outcomes will include salivary flow, oral health-related quality of life, swallowing symptoms, and perceived dryness. Patient-reported outcomes will also be assessed at week 12 to evaluate maintenance of treatment effects.
Detailed description
Sjögren disease (SjD) is a chronic systemic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal gland dysfunction. Dry mouth resulting from salivary gland hypofunction is one of the most common and burdensome manifestations of the disease. Salivary gland hypofunction contributes to chronic xerostomia, impaired oral comfort, difficulties in speaking and swallowing, alterations in taste perception, and reduced oral health-related quality of life.
Although dry mouth has been considered a consequence of immune-mediated salivary gland destruction, accumulating evidence suggests that glandular pathology alone cannot fully explain the severity of symptoms experienced by patients. The degree of exocrine gland destruction correlates only weakly with glandular function, and objective measures of salivary secretion do not consistently correspond with patients' subjective perception of oral dryness. These findings suggest that the symptoms experienced by patients cannot be explained solely by immune-mediated glandular destruction, indicating that additional mechanisms may contribute to xerostomia in SjD.
Current management of xerostomia in SjD includes saliva substitutes, chewing gum, systemic sialogogues, acupuncture, and electrical stimulation. However, current evidence supporting non-pharmacological interventions remains limited, and no specific intervention can currently be recommended with confidence because of the low quality and heterogeneity of the available studies. Consequently, there remains an unmet need for safe, accessible, and evidence-based non-pharmacological interventions for xerostomia in SjD.
Structured oral exercise programs have shown potential benefits for salivary secretion, oral motor function, and xerostomia symptoms in other populations, including older adults and individuals with radiation-induced xerostomia. Repeated oral motor activity may stimulate salivary secretion through mechanical and sensorimotor stimulation of the oral cavity. However, whether structured oral exercises improve xerostomia-related outcomes in patients with SjD remains unknown.
Therefore, the primary aim of this randomized controlled trial is to investigate whether a structured oral exercise programme, in addition to oral hygiene education and usual medical care, reduces xerostomia severity. Secondary aims are to evaluate its effects on salivary flow, oral health-related quality of life, and swallowing symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Oral exerciseParticipants in the experimental group will subsequently perform the exercises at home twice daily for six weeks. Written instructions and illustrated exercise sheets will be provided to facilitate adherence. The participants will be provided with an exercise diary to record exercise adherence throughout the intervention period. Participants will receive a weekly telephone call from the physiotherapist to encourage adherence and answer any questions regarding the exercise program. The oral exercise program will consist of a series of simple oral motor exercises involving coordinated movements of the jaw, lips, cheeks, and tongue. |
| Control group | No intervention | –Both groups will receive standardized oral hygiene education. All participants will be instructed to continue their usual medical treatment throughout the study period without changing medication unless clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a diagnosis of SjD based on the 2016 ACR/EULAR Classification Criteria;
- ≥18 years of age;
- residual stimulated whole salivary flow rate (≥0.05 ml/min);
- presence of subjective xerostomia (Visual Analogue Scale ≥ 50);
- stable pharmacological treatment for at least 4 weeks before enrolment;
Key exclusion criteria (6 listed)
- history of head and neck radiotherapy,
- severe cognitive impairment (i.e., dementia)
- psychiatric disorders preventing participation,
- neurological disorders affecting oral motor function,
- participation in structured oral motor or swallowing rehabilitation within the previous 2 months,
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 |
|---|---|---|
| Oral exerciseThe oral exercise program will consist of a series of simple oral motor exercises involving coordinated movements of the jaw, lips, cheeks, and tongue. The program was developed based on previously published oral exercise protocols in older adults and patients with xerostomia, with modifications for patients with SjD. | Other | Experimental group |
Primary outcome
Xerostomia Inventory (XI)
Time frame: baseline, week 6, week 12
The XI is a patient-reported assessment tool designed to evaluate the sensation of dry mouth. It consists of 11 items using a 5-point Likert scale, with each item scored from 1 (never) to 5 (very frequently). The total score ranges from 11 to 55, with higher scores indicating a more severe level of dry mouth.
7 secondary outcomes
EULAR Primary Sjögren's Syndrome Patient-Reported Index (ESSPRI)
Time frame: baseline, week 6, week 12
Dryness severity
Time frame: baseline, week 6, week 12
unstimulated whole salivary flow rate
Time frame: baseline, week 6
stimulated whole salivary flow rate
Time frame: baseline, immediately post-first exercise session, week 6
Oral Health Impact Profile-14
Time frame: baseline, week 6, week 12
Eating Assessment Tool-10
Time frame: baseline, week 6, week 12
Global Rating of Change scale
Time frame: week 6, week 12
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 8 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oral exercise in people with Sjogren Syndrome, run by Nazli Elif Nacar.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Xerostomia Inventory (XI) (time frame: baseline, week 6, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.