This review evaluates sialendoscopy-assisted ductal irrigation as a gland-directed adjunct therapy for xerostomia and recurrent sialadenitis in primary Sjögren’s syndrome. Compared with conservative care, this minimally invasive technique targets ductal obstruction and inflammation, potentially improving salivary flow, relieving symptoms, and restoring glandular function while maintaining an acceptable safety profile.
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Review Article
Sialendoscopy-Assisted Ductal Irrigation Versus Standard Care in Primary Sjögren’s Syndrome
In This Article
Summary
Abstract
Primary Sjögren’s syndrome (pSS) is a systemic autoimmune disease characterized by lymphocytic infiltration and progressive dysfunction of exocrine glands, leading to xerostomia, xerophthalmia, and recurrent sialadenitis. Conventional management focuses on symptomatic relief with saliva substitutes, oral hygiene, secretagogues, and systemic immunomodulation for extra-glandular disease. However, these approaches do not directly address ductal obstruction, periductal inflammation, or intraductal strictures that contribute to persistent glandular dysfunction. This review critically evaluates the role of sialendoscopy-assisted ductal irrigation compared with standard care in patients with pSS, with emphasis on clinical efficacy, safety, and future research needs. Randomized controlled trials, prospective cohorts, and systematic reviews were prioritized. Representative high-quality sources were examined in full, with data synthesized into comparative tables. Evidence from controlled trials and prospective cohorts indicates that sialendoscopy with ductal dilation and irrigation, often with corticosteroid instillation, improves unstimulated salivary flow, reduces glandular swelling, and alleviates subjective xerostomia more effectively than conservative therapy alone. Safety data suggest the procedure is well tolerated, with transient glandular discomfort and swelling being the most common adverse events. Compared to standard care, sialendoscopy provides unique advantages by directly targeting ductal pathology, though variability in techniques, small sample sizes, and limited long-term data constrain definitive conclusions. Sialendoscopy-assisted ductal irrigation represents a promising adjunctive therapy for managing salivary gland dysfunction in pSS, addressing pathophysiological mechanisms beyond symptomatic relief. While short-term efficacy and safety appear favourable, larger multicenter randomized trials, standardized protocols, and long-term outcome studies are needed to establish its role within evidence-based treatment algorithms.
Introduction
Primary Sjögren’s syndrome (pSS) is a systemic autoimmune disease that predominantly affects women and is characterized by chronic lymphocytic infiltration of exocrine glands, particularly the salivary and lacrimal glands1. The hallmark clinical manifestations xerostomia (dry mouth) and xerophthalmia (dry eyes) are accompanied by a range of secondary complications such as impaired oral health, dysphagia, dysarthria, dental caries, mucosal infections (notably candidiasis), and substantial impairment of quality of life2. Beyond glandular involvement, a subset of patients experiences extraglandular systemic disease, with potential manifestations across musculoskeletal, pulmonary, renal, and neurological systems, which further complicates disease management3. Conventional management strategies for pSS focus largely on symptomatic relief and the mitigation of systemic disease. Local measures such as saliva substitutes, meticulous oral hygiene practices, and preventive dental care remain cornerstones of therapy. Pharmacologic secretagogues, including muscarinic agonists like pilocarpine and cevimeline, are often prescribed to stimulate residual salivary gland function4. In cases of systemic involvement, immunomodulatory agents such as hydroxychloroquine, conventional immunosuppressants, or biologic therapies (e.g., rituximab, abatacept) may be employed in accordance with EULAR and other international guidelines5. However, these approaches do not specifically address the localized glandular and ductal abnormalities, such as ductal obstruction, mucus plugging, strictures, and periductal inflammation, that contribute significantly to refractory xerostomia and recurrent sialadenitis in a subset of patients6.
Over the last decade, sialendoscopy has emerged as a minimally invasive endoscopic technique that allows direct visualization and intervention within the salivary ductal system. Initially developed for obstructive sialadenitis caused by sialolithiasis, sialendoscopy has since been adapted for non-lithiasic inflammatory conditions, including pSS7. The procedure typically involves endoscopic ductal exploration, mechanical dilation, irrigation with saline to remove debris, and intraductal instillation of anti-inflammatory medications such as corticosteroids8. By addressing structural and inflammatory changes within the ductal system, sialendoscopy-assisted ductal irrigation has the potential to restore glandular patency, reduce local inflammation, and improve both objective and subjective measures of salivary gland function9. Several observational studies, prospective cohorts, and small randomized controlled trials have evaluated sialendoscopy in the management of pSS over the past 10–12 years5. These studies suggest improvements in xerostomia scores, salivary flow rates, and recurrence of sialadenitis episodes, with a favorable safety profile10. Nonetheless, the evidence base remains fragmented, with heterogeneity in study design, patient selection, procedural protocols (e.g., use of saline alone versus corticosteroid irrigation), and outcome measures. Furthermore, comparisons with established standard-of-care interventions remain limited, making it difficult to position sialendoscopy within existing therapeutic algorithms11.
A comprehensive synthesis and critical appraisal of the current literature on sialendoscopy-assisted ductal irrigation in primary Sjögren's syndrome (pSS) is timely and necessary. First, the increasing recognition of ductal pathology as a contributor to salivary dysfunction highlights the need to consider gland-targeted interventions alongside systemic immunomodulation12. Second, the growing clinical adoption of sialendoscopy requires a clear evidence framework to guide patient selection, procedural standardization, and integration with existing treatment strategies13. Finally, given the chronic and disabling nature of xerostomia in pSS, identifying durable, mechanism-based therapies that go beyond symptomatic palliation is a pressing clinical priority14. This review, therefore, aims to outline the pathophysiologic rationale for sialendoscopy in pSS, critically evaluate the available clinical evidence for its efficacy and safety, compare outcomes with standard care strategies, and highlight gaps in knowledge and future research directions. In routine clinical practice, sialendoscopy in primary Sjögren’s syndrome is most commonly performed for the management of recurrent sialadenitis, glandular swelling, and pain rather than as a primary therapy for xerostomia. While improvement in salivary flow and subjective dryness has been reported, xerostomia outcomes are typically considered secondary and may vary depending on residual glandular function10,11,12,13. This distinction is important when interpreting the literature and positioning gland-directed interventions within established treatment pathways. By systematically examining this evolving therapeutic approach, the review seeks to inform both clinical decision-making and the design of future trials that could establish the role of sialendoscopy-assisted ductal irrigation in the multidisciplinary management of primary Sjögren’s syndrome.
Over the past decade, increasing attention has been given to gland-directed therapies for the management of salivary gland dysfunction in primary Sjögren’s syndrome (pSS), particularly sialendoscopy-assisted ductal irrigation. Early interest in this technique arose from its success in treating obstructive sialadenitis due to sialolithiasis, which demonstrated that minimally invasive endoscopic ductal interventions could restore salivary flow and reduce gland inflammation1. These principles were subsequently applied to non-lithiasic inflammatory salivary gland diseases, including pSS2.
Several observational studies and prospective cohorts have evaluated sialendoscopy in pSS patients with refractory xerostomia and recurrent sialadenitis. Initial case series reported improvement in salivary gland swelling, pain, and subjective dryness following ductal dilation and saline irrigation3⁻5. These studies also highlighted the frequent presence of ductal stenosis, mucus plugs, and inflammatory changes on endoscopic examination, supporting a mechanistic rationale for intraductal intervention6.
The addition of intraductal corticosteroid irrigation has been a major focus of subsequent investigations. Corticosteroids such as triamcinolone acetonide are commonly diluted in saline and instilled directly into the ductal system to reduce periductal inflammation while avoiding systemic exposure7. Prospective studies have demonstrated that steroid-assisted irrigation leads to greater and more sustained improvements in xerostomia scores and salivary flow rates compared with saline irrigation alone8-10. Improvements in unstimulated whole salivary flow and patient-reported dryness have been observed within weeks of treatment and, in some cases, maintained for up to 6–12 months9.
Randomized controlled trials (RCTs), although limited in number and sample size, provide higher-quality evidence supporting this approach. The randomized trial by Karagozoglu et al. demonstrated statistically significant improvements in both subjective xerostomia and objective salivary flow in pSS patients treated with sialendoscopy and intraductal steroid irrigation compared with control groups receiving conservative therapy5. Similar findings have been reported in other controlled and quasi-randomized studies, reinforcing the consistency of therapeutic benefit10.
More recently, attention has shifted toward less invasive alternatives, such as office-based ductal irrigation without endoscopic visualization. Several cohort studies suggest that intraductal steroid irrigation alone may produce symptomatic relief comparable to that achieved with full sialendoscopy in selected patients11. These findings raise the possibility that the pharmacologic effect of localized corticosteroid delivery may be a primary driver of benefit, particularly in patients without complex ductal strictures12. However, sialendoscopy retains diagnostic value by allowing visualization of ductal pathology and enabling mechanical dilation when strictures or significant stenosis are present13.
Systematic reviews and narrative syntheses consistently conclude that sialendoscopy-assisted ductal irrigation is safe and associated with clinically meaningful improvements in xerostomia, salivary flow, and glandular symptoms in pSS514. Reported adverse events are generally mild and transient, most commonly temporary gland swelling or discomfort, with serious complications being rare3. Nonetheless, these reviews emphasize the heterogeneity of study designs, procedural protocols, outcome measures, and follow-up durations, which limits the strength of pooled conclusions15.
From a clinical perspective, current literature supports the use of sialendoscopy-assisted ductal irrigation as an adjunctive therapy rather than a replacement for standard care. Most studies evaluate this intervention in patients with persistent symptoms despite saliva substitutes, secretagogues, and optimized oral care16,7,8,9,10,11,12,13,14,15,16,17,18. Importantly, professional guidelines such as those from EULAR continue to recommend symptomatic therapies as first-line management, while acknowledging the potential role of gland-targeted interventions in selected refractory cases17.
Despite promising results, key gaps remain. There is a lack of large, multicenter RCTs directly comparing sialendoscopy-assisted irrigation with optimized systemic secretagogue therapy or office-based irrigation alone18. Additionally, predictors of therapeutic response—such as disease duration, imaging findings, or residual glandular function—have not been clearly defined19. Standardization of irrigation protocols, corticosteroid dosing, and outcome assessment tools is urgently needed to improve comparability across studies9. Future research should focus on integrating gland-directed procedures into stepwise treatment algorithms, identifying patient subgroups most likely to benefit, and evaluating long-term outcomes, including durability of symptom relief, gland preservation, and cost-effectiveness20. With further methodological refinement and high-quality evidence, sialendoscopy-assisted ductal irrigation has the potential to become an important component of personalized, mechanism-based management strategies for primary Sjögren’s syndrome.
Literature search strategy
To compile the evidence for this narrative review, we conducted targeted searches of biomedical literature databases, focusing on publications relevant to sialendoscopy, intraductal irrigation, and the management of xerostomia in primary Sjögren’s syndrome (pSS). The primary database searched was PubMed, MEDLINE, and Google Scholar. To capture additional studies not indexed in PubMed, we also screened major publisher platforms (Elsevier, Springer, and Taylor & Francis) and specialty journals in rheumatology, otolaryngology, oral medicine, and salivary gland disorders. Further sources were obtained from the reference lists of papers included and recent systematic reviews. The search terms included a combination of controlled vocabulary (MeSH) and free-text keywords, applied singly and in Boolean combinations. Core terms were: sialendoscopy, salivary duct irrigation OR intraductal irrigation; steroid irrigation OR intraductal corticosteroid; Sjogren’s syndrome OR primary Sjogren’s; xerostomia; sialadenitis; randomized controlled trial OR prospective cohort. The search covered publications from January 2000 through March 2025, reflecting the period during which sialendoscopy became widely available and adapted for inflammatory salivary gland diseases.
Study selection
Titles and abstracts were screened for relevance by two reviewers independently. Full-texts were retrieved when abstracts suggested inclusion. Priority was given to: Randomized controlled trials (RCTs) and controlled prospective studies evaluating sialendoscopy or intraductal irrigation in pSS. Followed by systematic reviews and meta-analyses synthesizing such studies. Followed by prospective and retrospective cohorts with detailed outcomes (xerostomia scores, salivary flow, recurrence of sialadenitis). Followed by guideline documents (notably EULAR and related professional society recommendations). Finally, key mechanistic or pilot studies clarifying procedural techniques, safety, or pathophysiological rationale.
Exclusion criteria include studies not in English, case reports with fewer than 5 patients, reviews or commentaries without original data, studies involving sialendoscopy for lithiasic disease only (sialolithiasis) unless they provided relevant insights into technique or outcomes applicable to pSS.
Data extraction and collection
From each eligible study, we extracted the following information: study design (RCT, cohort, retrospective, case series); population characteristics (diagnostic criteria for pSS, sample size, demographics); intervention details (sialendoscopy procedure, type of irrigation [saline, corticosteroid], number of sessions); comparator(s) (standard care: saliva substitutes, secretagogues, systemic immunomodulation).
The following outcome measures were assessed: subjective xerostomia scores (VAS, ESSPRI, patient-reported outcomes); objective salivary flow rates (unstimulated and stimulated whole saliva); recurrence/frequency of sialadenitis; glandular imaging changes (ultrasound, scintigraphy); adverse events and safety data; duration of follow-up.
Main findings and limitations
To strengthen validity, higher-quality evidence (multicenter RCTs, systematic reviews) was used as anchors for interpretation, while observational and uncontrolled studies were used to expand context and provide real-world insights. Where available, comparative data between sialendoscopy-assisted irrigation and standard care were emphasized. This review does not attempt to perform a formal meta-analysis; instead, it synthesizes the available clinical and translational evidence to provide a critical appraisal of sialendoscopy-assisted ductal irrigation in the management of xerostomia and salivary gland dysfunction in primary Sjögren's syndrome (pSS). Emphasis is placed on therapeutic efficacy, procedural safety, comparison with conventional care, and implications for clinical practice and future research.
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Review and Perspective
Pathophysiologic rationale for gland-directed irrigation in pSS
pSS pathogenesis involves immune-mediated destruction of glandular tissue, chronic periductal inflammation, epithelial injury, and progressive acinar atrophy and fibrosis5. Ductal changes stenosis, strictures, mucus plugs can further impede salivary flow and predispose to stagnation and recurrent bacterial or inflammatory flares (sialadenitis). Direct mechanical and pharmacologic intervention of the ductal system aims to physically clear mucus, inspissated secretions, and debris that limit flow; dilate strictures to re-establish luminal patency and facilitate secretion drainage; deliver high local concentrations of anti-inflammatory agents (typically corticosteroids) directly to affected periductal tissues without systemic exposure, potentially reducing local inflammation and interrupting vicious cycles of obstruction and inflammation; and restore or improve gland function by promoting drainage, reducing intraglandular pressure, and possibly modulating local immune responses3.
The interplay between immune-mediated glandular destruction, periductal inflammation, and mechanical obstruction underlies the persistent xerostomia seen in pSS. While systemic immunomodulators address the inflammatory component, they do not directly relieve intraductal pathology. Figure 1 summarizes the proposed mechanisms of disease and highlights how sialendoscopy-assisted ductal irrigation may intervene at multiple levels mechanical clearance of debris, ductal dilation, localized steroid delivery, and modulation of inflammatory pathways.
Figure 1: Pathophysiology of salivary gland dysfunction in primary Sjögren’s syndrome and therapeutic targets of sialendoscopy-assisted irrigation. Please click here to view a larger version of this figure.
This rationale supports both sialendoscopy (direct endoscopic visualization with interventional maneuvers) and less invasive office-based ductal irrigation (retrograde catheter irrigation without endoscopy) as evidenced in Table 1. Mechanistic data are limited, but early clinical responses and objective salivary flow improvements reported in trials are consistent with this model10,11,12,13,14,15,16,17,18.
| S.No. | Mechanism | Evidence Source | Clinical Correlate | Knowledge Gaps | References |
| 1 | Mechanical clearance of mucus plugs/debris | Endoscopic visualization, pilot studies | Reduced episodes of painful sialadenitis | Quantitative data on debris burden and clearance lacking | [15] |
| 2 | Ductal dilation & restoration of patency | Interventional case series | Improved salivary flow, reduced ductal obstruction | Durability of dilation unclear; risk of restenosis | [16] |
| 3 | Local corticosteroid delivery | RCTs (Karagozoglu 2021, Frontiers Immunology 2022) | Improved xerostomia scores, ESSPRI | Optimal steroid type, dose, frequency not standardized | [8] |
| 4 | Modulation of periductal inflammation | Limited mechanistic studies (salivary cytokines pre/post irrigation) | Symptom relief persisting beyond acute irrigation | No clear biomarker signature; need translational studies | [17] |
| 5 | Pressure-mediated flushing of inflammatory milieu | Office irrigation and pilot data | Temporary symptom relief even with saline alone | Mechanistic confirmation lacking | [18] |
Table 1: Proposed mechanisms of benefit from sialendoscopy-assisted irrigation in Pss.
Procedural approaches: techniques and variations
There are two broad procedural strategies discussed in the literature
Diagnostic/Interventional sialendoscopy with intraductal irrigation: Performed under local or general anaesthesia depending on patient comfort and setting. A small endoscope (0.8–1.6 mm) is inserted into Stensen’s or Wharton’s duct, permitting visualization of ductal pathology (mucus plugs, strictures, mucosal erythema). Interventional tools allow dilation, stone removal, and targeted irrigation9. Irrigation solutions vary normal saline, corticosteroid solutions (e.g., triamcinolone acetonide diluted in saline), or saline with adjunctive agents (antibiotics, hyaluronidase in some reports). Corticosteroid instillation is the most reported pharmacologic adjunct19. For the purpose of this review, standard conservative care was defined as symptomatic and pharmacologic management strategies, including saliva substitutes, topical oral care, muscarinic agonists (pilocarpine, cevimeline), preventive dental measures, and systemic immunomodulatory therapy when clinically indicated. Gland-directed interventions included office-based ductal irrigation and sialendoscopy-assisted ductal dilation and irrigation, with or without intraductal corticosteroid instillation.
Office-based ductal irrigation (non-endoscopic): A cannula or catheter is introduced into the duct orifice, and retrograde irrigation is performed in the clinic without endoscopic visualization. This approach is simpler, more cost-effective, and repeatable, but does not permit direct visualization or mechanical dilation beyond that achieved by catheter passage. Several recent trials and observational studies have used office irrigation with saline or steroid solutions9.
Technique variables that differ across studies: Choice of saline vs steroid, steroid concentration, and volume, whether both parotid and submandibular glands were treated, number and frequency of irrigation sessions (single session vs multiple sessions over weeks), and use of adjunctive dilation or extraction maneuvers20. These procedural heterogeneities complicate pooled interpretation. Several prospective and randomized studies have evaluated sialendoscopy-assisted ductal irrigation in patients with primary Sjögren’s syndrome, demonstrating improvements in salivary flow and subjective dryness (Table 2).
| S.No. | Study Design | Intervention | Comparator | Sample Size | Outcomes | Main Findings | Follow-up | References |
| 1 | Randomized controlled trial (single-blind) | Sialendoscopy with saline or saline + triamcinolone irrigation | No irrigation (control) | 45 | UWS, SWS, xerostomia scores | Salivary flow and dryness improved in irrigation groups; some effects persisted up to 60 weeks | 60 weeks | [16] |
| 2 | Randomized controlled trial | Office ductal irrigation with saline vs steroid (TA) | Baseline control | 40 | Salivary flow, patient-reported dryness | Both saline and steroid improved secretion; no major safety issues | 24 weeks | [21] |
| 3 | Prospective cohort | Sialendoscopy + ductal steroid irrigation cycles | None (before-after) | 20 | Episodes of sialadenitis, xerostomia scores | Reduced recurrence of painful sialadenitis; improved dryness | 6–12 months | [22] |
| 4 | Cohort | Sialendoscopy with steroid irrigation | Standard care (historical control) | 30 | Salivary flow, xerostomia VAS | Symptom improvement and modest flow increase; low complication rates | 6 months | [23] |
| 5 | Systematic/narrative | Mixed: sialendoscopy ± irrigation | Standard care | Multiple studies | Salivary function, QoL | Consensus: promising but heterogeneous; need larger RCTs | Variable | [22] |
Table 2: Key clinical studies evaluating sialendoscopy-assisted ductal irrigation in primary Sjögren’s syndrome.
Against conservative standard care (saliva substitutes, pilocarpine/cevimeline), sialendoscopy-assisted irrigation offers a gland-targeted approach that addresses ductal obstruction and periductal inflammation directly. While pharmacologic secretagogues improve salivary flow in patients with residual gland function, their systemic side effects and limited impact on ductal pathology restrict efficacy in refractory cases. By contrast, sialendoscopy and office-based ductal irrigation can restore patency, clear mucus plugs, and deliver corticosteroids locally with fewer systemic effects. This comparative framework is summarized in Figure 2, which visually contrasts the mechanisms, outcomes, and safety of standard care versus sialendoscopy-assisted ductal irrigation.
Figure 2: Comparative overview of standard care and sialendoscopy-assisted ductal irrigation in primary Sjögren’s syndrome, highlighting mechanisms, outcomes, and safety considerations. Please click here to view a larger version of this figure.
On the other side, compared with conventional conservative management, sialendoscopy provides direct ductal clearance and intraductal drug delivery, offering unique advantages and limitations as summarized in Table 3.
| S.No. | Aspect | Standard Care (Saliva substitutes, secretagogues, systemic therapy) | Sialendoscopy-Assisted Ductal Irrigation | References |
| 1 | Target mechanism | Symptomatic relief (moisturizing, systemic muscarinic stimulation); systemic immunomodulation for extraglandular disease | Local ductal clearance, stricture dilation, intraductal corticosteroid delivery | [24] |
| 2 | Effect on salivary flow | Variable; pilocarpine/cevimeline increase flow if gland reserve remains; substitutes do not restore flow | RCTs and cohorts show modest but significant increases in UWS/SWS | [25] |
| 3 | Effect on xerostomia | Often partial, many patients remain symptomatic | Improvements in dryness scores, CODS, ESSPRI in multiple trials | [26] |
| 4 | Effect on recurrent sialadenitis | Not directly targeted | Reduced recurrence in several prospective studies | [27] |
| 5 | Safety | Systemic side effects (e.g., sweating, flushing, GI upset, cardiovascular effects) from secretagogues; long-term safety known | Local adverse events rare (transient ductal trauma, swelling); systemic steroid exposure minimal | [13] |
| 6 | Evidence base | Large trials for secretagogues; EULAR guideline-endorsed | Emerging RCT and cohort data, systematic reviews support promise but stress heterogeneity and limited durability data | [5] |
| 7 | Durability of effect | Requires continuous systemic therapy; effects reversible after discontinuation | Benefits may persist weeks–months, but often require repeat irrigation; long-term durability >1 year uncertain | [28] |
| 8 | Accessibility | Widely available, oral medications, low procedural demand | Requires trained operator, equipment; more costly, limited availability outside specialized centers | [29] |
Table 3: Comparative overview: sialendoscopy-assisted irrigation vs standard care in pSS.
Against conservative standard care (saliva substitutes, pilocarpine/cevimeline): Standard pharmacologic secretagogues (pilocarpine, cevimeline) and symptomatic measures are recommended as first-line therapies by professional bodies (EULAR, national guidelines)5. These medications increase salivary flow in many patients but have systemic side effects (sweating, GI upset) and may be less effective in glands with severe structural damage. Sialendoscopy targets ductal obstruction/inflammation directly and could be complementary: in some RCTs, sialendoscopy-assisted irrigation produced objective salivary flow increases over baseline and symptomatic improvement that are clinically meaningful30. However, head-to-head randomized comparisons versus systemic secretagogues are lacking; thus, the current evidence supports sialendoscopy as an adjunctive gland-directed option for patients with refractory symptoms or recurrent obstructive events.
Irrigation alone vs sialendoscopy: Some studies indicate that intraductal steroid irrigation alone (office irrigation) may achieve similar outcomes to sialendoscopy plus steroid instillation, suggesting the pharmacologic irrigation may be a major driver of benefit31,32. Some observational data highlight that ductal steroid irrigation alone had comparable symptom improvements in select cohorts33,34. This raises the question of whether full sialendoscopy (with visualization/dilation) is always necessary or whether simpler office irrigation can be attempted first. However, visualization allows diagnosis of strictures or other pathology and targeted mechanical intervention that office irrigation cannot provide32.
Outcomes: objective and patient-reported measures
Objective flow rates: The RCT evidence shows modest but statistically significant increases in unstimulated and stimulated whole saliva (UWS, SWS) in irrigation groups versus baseline and control in some trials19,32,33. The magnitude of benefit varies by study and by whether steroids were used in the irrigation solution19.
Patient-reported xerostomia and quality of life: Clinical trials and cohorts report improvements in validated xerostomia inventories (XI), the Clinical Oral Dryness Score (CODS), and disease-specific symptom indices (ESSPRI), with some improvements sustained at medium-term follow-up. Patient-reported reductions in painful sialadenitis episodes and subjective dryness are common findings8.
Duration of benefit: Reported durations of effect vary; Previous report durable improvements up to 12–60 weeks, but longer-term durability beyond 1 year is less well characterized. Recurrence of symptoms can occur, and repeat irrigation cycles are commonly used in practice32.
Safety: Sialendoscopy and office ductal irrigation are generally well tolerated. Reported adverse events include transient mild ductal discomfort, swelling, ductal trauma or perforation (rare), and transient facial nerve irritation with parotid procedures (rare). No major systemic adverse events have been consistently reported with local corticosteroid irrigation, although standard precautions about infection risk and steroid effects apply33. Overall, safety profiles in reported series are favorable relative to invasive surgical options. Overall, sialendoscopy-assisted ductal irrigation was well tolerated, with adverse events generally mild and transient, most commonly gland swelling or discomfort (Table 4).
| S.No. | Adverse Event | Frequency (reported) | Severity | Notes | References |
| 1 | Transient ductal swelling/discomfort | 10–20% of cases | Mild, self-limiting | Usually resolves in 24–48h | [34] |
| 2 | Ductal trauma/perforation | <5% | Mild–moderate | Rare; operator-dependent | [34] |
| 3 | Facial nerve irritation (parotid procedures) | Rare (<2%) | Mild | Transient weakness, recovers spontaneously | [35] |
| 4 | Infection/exacerbation of sialadenitis | Rare (<3%) | Moderate | Prophylactic antibiotics sometimes used | [24] |
| 5 | Systemic steroid-related adverse effects | Very rare | Mild | Minimal due to localized administration | [36] |
| 6 | Need for repeat procedure | Common (30–50%) | Not adverse per se | Reflects limited durability of effect | [36] |
Table 4: Safety profile of sialendoscopy-assisted irrigation.
Overall, reported complications are minor and self-limited, with transient swelling and discomfort being the most frequent. Ductal perforation is rare, and the overall incidence of adverse events remains low (3%–5%). These findings are summarized in Table 4 and visually represented in Figure 3, which illustrates the spectrum and relative frequency of complications associated with sialendoscopy in pSS.
Figure 3: Safety and complications of sialendoscopy-assisted ductal irrigation in primary Sjögren’s syndrome, showing the relative frequency of minor, transient, and rare adverse events. Please click here to view a larger version of this figure.
Critical appraisal of the evidence
Strengths in the literature: Emergence of randomized controlled data provides higher-quality evidence than earlier case reports. Converging signals from RCTs, pilot studies, and cohorts indicate improvements in objective salivary flow and patient-reported dryness. The procedures are minimally invasive and have acceptable safety profiles in reported series37.
Limitations and sources of bias: Heterogeneity of techniques and solutions - Studies differ in whether sialendoscopy or office irrigation was used, whether corticosteroids were added, specific steroid formulations and doses, volumes instilled, and whether both major glands were treated. This impedes pooled meta-analysis and generalizability38. Small sample sizes and single-center designs - Many reports are small, underpowered, and vulnerable to selection bias. Larger multicenter trials are lacking. Unclear mechanism of benefit - Some evidence suggests steroid irrigation is the active component, with comparable outcomes between sialendoscopy and ductal steroid irrigation alone in observational studies. If so, simpler office irrigation could suffice for many patients, but the evidence is currently insufficient to define which patients need full sialendoscopy39. Short to medium follow-up - Data beyond 1 year are sparse; long-term efficacy and effects on glandular structural progression are not well known. Lack of head-to-head comparisons with systemic secretagogues - No well-designed RCTs directly compare sialendoscopy/irrigation against optimized systemic secretagogue therapy (pilocarpine/cevimeline) or combinations thereof. Thus, the relative place in therapy remains based on indirect comparisons and clinical reasoning40. Patient selection unclear - It is not well-established which phenotypes (e.g., early disease with preserved acinar tissue vs advanced fibrotic glands, presence of ductal strictures on imaging) benefit most. Biomarker or imaging predictors of response are lacking37.
Practical considerations for clinicians
Patient selection: Candidates for sialendoscopy-assisted irrigation generally include pSS patients with persistent symptomatic xerostomia despite optimized local and systemic therapies; recurrent painful sialadenitis episodes or clinically suspected ductal obstruction/stenosis; localized ductal pathology suggested on imaging (sialography/ultrasound) or clinical exam41. Patients with severe irreversible glandular destruction (advanced atrophy/fibrosis) are less likely to benefit from restoration of flow; conversely, earlier disease or those with duct-predominant pathology may show greater gains. Individualized assessment using gland imaging and discussion of expected benefits is essential42.
Choice of procedure: office irrigation vs sialendoscopy: A pragmatic, stepwise approach is reasonable: consider office-based retrograde ductal irrigation (saline ± steroid) as a low-resource, low-burden initial intervention for patients without clear evidence of complex ductal pathology. Reserve sialendoscopy when diagnostic visualization, stricture dilation, or mechanical interventions (stone extraction, stricturoplasty) may be required, or when initial office irrigation fails. This algorithm reflects emerging comparative observations but needs prospective validation41.
Irrigation solution and frequency: Most data support saline irrigation with or without intraductal corticosteroid (triamcinolone, commonly used). Specific concentrations, volumes, and repeat intervals differ across studies; many practitioners perform a series of irrigation sessions (e.g., 1–3 sessions over weeks) and then administer repeat treatments as needed. Local protocols should weigh potential benefits against procedure burden and patient preference. Until standardized protocols are available, clinicians should document techniques and outcomes to contribute to evidence generation43.
Adjunctive care: Continue standard symptomatic measures (saliva substitutes, meticulous oral hygiene) and consider systemic secretagogues if appropriate. Ensure multidisciplinary coordination with rheumatology and dentistry44.
Safety and counseling: Counsel patients that sialendoscopy and ductal irrigation are minimally invasive with low reported complication rates, but that symptom improvement varies, repeat procedures may be needed, and long-term durability is uncertain. Discuss alternatives (systemic secretagogues, conservative measures) and the lack of definitive evidence positioning these procedures as disease-modifying for pSS45. Assessment of xerostomia outcomes across trials has been heterogeneous, with studies employing visual analogue scales (VAS), Xerostomia Inventory (XI), Clinical Oral Dryness Score (CODS), and the ESSPRI index, among others, in Table 5. This variability complicates meta-analysis and underscores the need for standardized core outcome sets in future trials.
| S.No. | Instrument | Description | Strengths | Limitations | References |
| 1 | VAS Xerostomia | Visual analogue scale (0–10) | Simple, patient-friendly | Not disease-specific | [46] |
| 2 | Xerostomia Inventory (XI) | 11-item questionnaire | Validated, multidimensional | Lengthy for clinic | [45] |
| 3 | CODS | Clinical Oral Dryness Score (exam-based) | Objective signs of dryness | Requires trained examiner | [19] |
| 4 | ESSPRI (EULAR Sjögren’s Syndrome Patient Reported Index) | Covers dryness, pain, fatigue | Disease-specific, validated | More general, not xerostomia-specific | [5] |
Table 5: Patient-Reported Outcome Instruments in Sialendoscopy Studies.
Research gaps and future directions
Large, multicenter randomized controlled trials: Trials should compare (a) sialendoscopy + steroid irrigation vs office steroid irrigation vs sham/no irrigation, and (b) gland-directed therapies vs optimized systemic secretagogue therapy (or combination approaches). Standardized outcome measures (UWS/SWS, CODS, XI, ESSPRI) and longer follow-up (≥12–24 months) are needed. The Karagozoglu RCT provides a model, but is underpowered for subgroups and long-term durability5.
Standardization of techniques: A consensus on irrigation solutions (type and dose of steroid), volumes, session frequency, and definitions of technical success would improve comparability across studies. Procedural checklists and reporting standards (like CONSORT extensions for procedural interventions) should be adopted47.
Predictors of response and biomarkers: Imaging (ultrasound, sialography), salivary proteomics, or histologic/serologic markers might identify patients most likely to benefit. Mechanistic studies examining the local immunologic milieu pre- and post-irrigation (cytokines, lymphocytic activity) could clarify whether local anti-inflammatory delivery has disease-modifying potential48.
Health economics and implementation: Cost-effectiveness comparing office irrigation, sialendoscopy, and standard care (including quality-adjusted life years for xerostomia relief) will inform policy and access, particularly in resource-constrained settings49.
Long-term safety surveillance: While short-term safety appears acceptable, long-term effects, including potential ductal scarring from repeated instrumentation or local steroid–related complications, need prospective monitoring50. These findings are summarized in Figure 4.
Figure 4: Standard care versus sialendoscopy-assisted irrigation pathways in primary Sjögren’s syndrome. Please click here to view a larger version of this figure.
Despite promising short-term results, long-term outcomes, standardized protocols, and integration with systemic therapy remain underexplored; ongoing clinical trials and identified gaps are summarized in Table 6.
| S.No. | Domain | Current Status | Research Priority | References |
| 1 | Comparative effectiveness | Few small RCTs (saline vs steroid; irrigation vs no irrigation) | Large, multicenter RCTs comparing sialendoscopy vs office irrigation vs systemic secretagogues | [51] |
| 2 | Standardization of technique | Wide heterogeneity in irrigation solutions, frequency, steroid type | Consensus protocols for irrigation fluid, dosage, session numbers | [52] |
| 3 | Biomarker-driven patient selection | No validated predictors of response | Develop imaging (ultrasound scoring), salivary proteomics, or cytokine markers | [53] |
| 4 | Long-term durability | Data up to 60 weeks in one trial; most ≤12 months | ≥2–3 year follow-up studies, registries, durability of ductal patency | [54] |
| 5 | Health economics | No formal cost-effectiveness analyses | Model comparisons of cost, QALY gain: systemic drugs vs irrigation vs combined | [55] |
| 6 | Integration with systemic therapy | No head-to-head with pilocarpine/cevimeline | RCTs testing combination approaches (secretagogues + irrigation) | [56] |
Table 6: Key research priorities and gaps.
Recommendations for clinicians and researchers
In addition to clinical endpoints, some studies have explored salivary gland ultrasonography, scintigraphy, and MRI sialography, as well as cytokine and proteomic analyses, to monitor therapeutic response55,56,57,58,59. These remain exploratory, with limited validation in large cohorts in Table 7.
| S.No. | Biomarker | Utility in pSS | Use in irrigation/sialendoscopy | Limitations | References |
| 1 | Salivary gland ultrasound | Detects hypoechoic foci, ductal dilatation | Some trials used pre/post-imaging | Operator-dependent, not standardized | [60] |
| 2 | Scintigraphy | Functional imaging of secretion | Used in early pilot studies | Low resolution, radiation | [61] |
| 3 | MRI sialography | High-resolution ductal mapping | Rare, research use | Expensive, not widely available | [62] |
| 4 | Salivary cytokines (IL-6, TNF-α) | Track inflammatory activity | Small mechanistic studies | Lack validation | [63] |
| 5 | Proteomic profiling | Detects secretory protein changes | Early-phase studies | Not yet clinically available | [64] |
Table 7: Imaging and Biomarkers Used in Monitoring Response.
Outcomes with standard conservative therapy
Standard management of xerostomia in primary Sjögren’s syndrome primarily involves symptomatic and pharmacologic measures. Saliva substitutes and topical lubricants improve oral comfort but do not restore glandular secretory function. Muscarinic agonists such as pilocarpine and cevimeline have demonstrated efficacy in increasing salivary flow and reducing dryness symptoms in patients with residual glandular activity; however, their clinical utility may be limited by systemic adverse effects, including sweating, gastrointestinal discomfort, urinary frequency, and treatment discontinuation. Importantly, conservative therapies do not directly address ductal obstruction, mucus plugging, or inflammatory ductal changes that may contribute to recurrent glandular swelling and pain.
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Conclusions
Sialendoscopy-assisted ductal irrigation has emerged as a novel and increasingly recognized intervention for the management of salivary gland dysfunction in pSS. Unlike standard conservative measures such as saliva substitutes, oral lubricants, muscarinic agonists, and systemic immunomodulators, sialendoscopy directly addresses the intraductal pathophysiology of the disease. By enabling visualization of the ductal tree, mechanical dilation of strictures, clearance of mucus plugs or debris, and targeted intraductal delive...
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Disclosures
The authors affirm that they do not have any financial conflicts of interest.
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