Intraoperative visualisation and treatment of salivary glands in Sjögren's syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS):protocol for a phase I single-centre, single-arm, exploratory study

INTRODUCTION: We established a promising sialendoscopic treatment for in vivo enhancement of salivation in salivary glands affected by Sjögren's syndrome (SS). In this technique, the ducts of the salivary glands are irrigated with saline and steroids. This allows for dilatation of ductal strictures and removal of debris. Unfortunately, it is not possible to assess the delivery and penetration of saline or medications in the ductal system and parenchyma. To address this problem, we will conduct contrast-enhanced ultrasound sialendoscopy (CEUSS) using sulphur hexafluoride microbubbles. To the best of our knowledge, microbubbles have never been used for the treatment of salivary glands in SS. It is, therefore, imperative to test this application for its safety and feasibility. METHODS AND ANALYSIS: A single-arm phase I study will be performed in 10 SS patients. Under local anaesthesia, ultrasound (US) guided infusion of the parotid and submandibular glands with microbubbles will be performed. Continuous US imaging will be used to visualise the glands, including the location of strictures and occlusions. Main outcomes will be the evaluation of safety and technical feasibility of the experimental treatment. Secondary outcomes will consist of determinations of unstimulated whole mouth saliva flow, stimulated whole mouth saliva flow, stimulated parotid saliva flow, clinical oral dryness, reported pain, xerostomia, disease activity, salivary cytokine profiles and clinical SS symptoms. Finally, salivary gland topographical alterations will be evaluated by US. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the Medical Ethics Committee of the Amsterdam University Medical Centre, Amsterdam, The Netherlands (NL68283.029.19). data will be presented at national and international conferences and published in a peer-reviewed journal. The study will be implemented and reported in line with the Standard Protocol Items: Recommendations for Interventional Trials' statement. TRIAL REGISTRATION NUMBERS: The Netherlands Trial Register: NL7731, MREC Trial Register: NL68283.029.19; Pre-results

Dental implants in dentate primary and secondary Sjögren's syndrome patients:A multicenter prospective cohort study

Objectives: To prospectively assess the clinical performance and patient-reported outcomes of dental implants in dentate patients with primary and secondary Sjögren's syndrome (pSS and sSS, respectively) compared to patients without SS. Materials and Methods: Thirty-seven implants were placed in 17 patients with pSS/sSS and 26 implants in 17 non-SS patients to replace missing (pre)molars. Clinical performance, marginal bone-level changes, patient satisfaction, and oral health-related quality of life (OHRQoL) were assessed at 1 (T1), 6 (T6), 12 (T12), and 18 (T18) months after placement of the superstructure. Marginal bone-level changes were measured on standardized dental radiographs. Clinical parameters included implant and crown survival, plaque, bleeding and gingival indices, and probing depth. Patient satisfaction and OHRQoL were assessed with validated questionnaires. Results: Implant survival at T18 was 100% in the patients with pSS/sSS and 96.2% in the non-SS group. Mean marginal bone loss at T18 did not differ between patients with pSS/sSS and non-SS patients, 1.10 ± 1.04 and 1.04 ± 0.75 mm, respectively (p =.87). Clinical performance was good with no differences between the groups for all outcome measures (p >.05). OHRQoL in patients with pSS/sSS had improved significantly after placement of implant supported crowns at all measuring moments compared to baseline (p <.05). Nevertheless, patient satisfaction and OHRQoL remained significantly higher for patients without SS at all measuring moments (p <.05). Conclusion: Dental implants can be successfully applied in dentate patients with pSS/sSS and have a positive effect on OHRQoL

Data from: Sialendoscopy enhances salivary gland function in Sjögren’s syndrome: a 6 month follow-up, randomized and controlled, single blind study

Objectives: To assess the effect of sialendoscopy of the major salivary glands on salivary flow and xerostomia in patients with Sjögren’s syndrome (SS). Methods: Forty nine SS patients were randomly assigned to a control group (n=15) and two intervention groups: irrigation of the major glands with saline (n=16) or with saline followed by triamcinolone acetonide (TA) in saline (n=18). Unstimulated whole saliva flow (UWS), chewing stimulated whole saliva flow (SWS), citric-acid stimulated parotid flow (SPF), Clinical Oral Dryness Score (CODS), Xerostomia Inventory score (XI), and EULAR SS Patient Reported Index (ESSPRI) were obtained 1 week (T0) before, and 1(T1), 8(T8), 16(T16), and 24(T24) weeks after sialendoscopy. Results: Median baseline UWS, SWS and SPF scores were, respectively, 0.14, 0.46, and 0.22mL/min. After intervention, significant increases in UWS and SWS were observed in the saline group (at T8 (p=0.013) and T24 (p=0.004)) and the saline/TA group (at T24 (p=0.03) and T=16 (p=0.035). SPF was increased significantly in the saline/TA group at T24 (p=0.03). XI scores declined after sialendoscopy in both intervention groups. Compared to the control group, CODS, XI, and ESSPRI improved in the intervention groups. UWS, SWS, and SPF were higher in the intervention groups compared to the control group, but these differences were not significant except for SPF in the saline/TA group at T24 (p=0.005). Conclusions: Irrigation of the major salivary glands in SS patients enhances salivary flow and reduces xerostomia up to 6 months after sialendoscopy

Sialendoscopy enhances salivary gland function in Sjögren's syndrome:a 6-month follow-up, randomised and controlled, single blind study

Objectives to assess the effect of sialendoscopy of the major salivary glands on salivary flow and xerostomia in patients with Sjögren’s syndrome (SS). Methods Forty-nine patients with SS were randomly assigned to a control group (n=15) and two intervention groups: irrigation of the major glands with saline (n=16) or with saline followed by triamcinolone acetonide (tA) in saline (n=18). Unstimulated whole saliva flow (UWS), chewing-stimulated whole saliva flow (SWS), citric acid-stimulated parotid flow (SpF), Clinical oral dryness Score (CodS), xerostomia Inventory (xI) score and the European League Against rheumatism (EULAr) SS patient-reported Index (ESSprI) were obtained 1 week (t0) before, and 1 (t1), 8 (t8), 16 (t16) and 24 (t24) weeks after sialendoscopy. Results Median baseline UWS, SWS and SpF scores were 0.14, 0.46 and 0.22 mL/min, respectively. After intervention, significant increases in UWS and SWS were observed in the saline group (at t8 (p=0.013) and t24 (p=0.004)) and the saline/tA group (at t24 (p=0.03) and t=16 (p=0.035)). SpF was increased significantly in the saline/tA group at t24 (p=0.03). xI scores declined after sialendoscopy in both intervention groups. Compared with the control group, CodS, xI and ESSprI improved in the intervention groups. UWS, SWS and SpF were higher in the intervention groups compared with the control group, but these differences were not significant except for SpF in the saline/tA group at t24 (p=0.005). Conclusions Irrigation of the major salivary glands in patients with SS enhances salivary flow and reduces xerostomia up to 6 months after sialendoscopy

Data Master file Sialendoscopy 6 Months Dryad

SPSS data file containing clinical outcome measures such as salivary flow, CODS, Xerostomia Inventory and ESSPRI data for 3 groups of patients participating in this study. Treatment groups: 1 = control group, 2 = saline group, 3 = saline/TA group. Data is measured at baseline (T0), 1 week (T1), 8 weeks (T8), 16 weeks (T16) and 24 week (T24) after intervention. The data file is created with Statistical Package for the Social Sciences software (SPSS; .sav file). Abbrevations: SS Sjögren's Syndrome, UWS = Unstimulated Salivary Flow, SWS = Stimulated Salivary Flow, SPF = Stimulated Parotid Flow, CODS = Clinical Oral Dryness Score, XI = Xerostomia Inventory, ESSPRI = EULAR Sjögren's Syndrome Patient Reported Index. Total ESSPRI and the seperate ESSPRI dryness domain is reported

Dental implants in dentate primary and secondary Sjögren's syndrome patients: a multicenter prospective cohort study

Objectives: To prospectively assess the clinical performance and patient-reported outcomes of dental implants in dentate patients with primary and secondary Sjögren's syndrome (pSS and sSS, respectively) compared to patients without SS. Materials and Methods: Thirty-seven implants were placed in 17 patients with pSS/sSS and 26 implants in 17 non-SS patients to replace missing (pre)molars. Clinical performance, marginal bone-level changes, patient satisfaction, and oral health-related quality of life (OHRQoL) were assessed at 1 (T1), 6 (T6), 12 (T12), and 18 (T18) months after placement of the superstructure. Marginal bone-level changes were measured on standardized dental radiographs. Clinical parameters included implant and crown survival, plaque, bleeding and gingival indices, and probing depth. Patient satisfaction and OHRQoL were assessed with validated questionnaires. Results: Implant survival at T18 was 100% in the patients with pSS/sSS and 96.2% in the non-SS group. Mean marginal bone loss at T18 did not differ between patients with pSS/sSS and non-SS patients, 1.10 ± 1.04 and 1.04 ± 0.75 mm, respectively (p =.87). Clinical performance was good with no differences between the groups for all outcome measures (p >.05). OHRQoL in patients with pSS/sSS had improved significantly after placement of implant supported crowns at all measuring moments compared to baseline (p <.05). Nevertheless, patient satisfaction and OHRQoL remained significantly higher for patients without SS at all measuring moments (p <.05). Conclusion: Dental implants can be successfully applied in dentate patients with pSS/sSS and have a positive effect on OHRQoL