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

Sialendoscopy increases saliva secretion and reduces xerostomia up to 60 weeks in Sjogren's syndrome patients:a randomized controlled study

OBJECTIVE: 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-five patients with SS were randomly assigned to a control group (no irrigation, control, n = 15), to irrigation of the major salivary glands with saline (saline, n = 15) or to irrigation with saline followed by corticosteroid application (triamcinolone acetonide in saline, saline/TA, n = 15). Unstimulated whole saliva flow (UWSF), chewing-stimulated whole saliva flow (SWSF), citric acid-stimulated parotid flow, Clinical Oral Dryness Score (CODS), Xerostomia Inventory (XI) and EULAR SS Patient Reported Index (ESSPRI) scores were obtained 1 week before (T0), and 1, 8, 16, 24, 36, 48 and 60 weeks after sialendoscopy. Data were analysed using linear mixed models. RESULTS: Irrespective of the irrigation protocol used, sialendoscopy resulted in an increased salivary flow during follow-up up to 60 weeks. Significant between-group differences in the longitudinal course of outcomes were found for UWSF, SWSF, XI and ESSPRI scores (P = 0.028, P = 0.001, P = 0.03, P = 0.021, respectively). UWSF at 60 weeks was higher compared with T0 in the saline group (median: 0.14 vs median: 0.10, P = 0.02) and in the saline/TA group (median: 0.20, vs 0.13, P = 0.035). In the saline/TA group SWSF at 48 weeks was higher compared with T0 (median: 0.74 vs 0.38, P = 0.004). Increase in unstimulated salivary flow was also reflected in improved CODS, XI and ESSPRI scores compared with baseline. CONCLUSION: Irrigation of the major salivary glands in patients with SS increases salivary flow and reduces xerostomia

Postoperative Airway Obstruction by a Bone Fragment

Postoperative airway obstructions are potentially life-threatening complications. These obstructions may be classified as functional (sagging tongue, laryngospasm, or bronchospasm), pathoanatomical (airway swelling or hematoma within the airways), or foreign body-related. Various cases of airway obstruction by foreign bodies have previously been reported, for example, by broken teeth or damaged airway instruments. Here we present the exceptional case of a postoperative airway obstruction due to a large fragment of the patient's maxillary bone, left accidentally in situ after transoral surgical tumor resection. Concerning this type of airway obstruction, we discuss possible causes, diagnosis, and treatment options. Although it is an exceptional case after surgery, clinicians should be aware of this potentially life-threatening complication. In summary, this case demonstrates that the differential diagnosis of postoperative airway obstructions should include foreign bodies derived from surgery, including tissue and bone fragments

Efficacy of glandular irrigation and sialendoscopy in salivary glands affected by Sjögren's syndrome

Sjögren's syndrome is a progressive disease characterized by a gradual and irreversible decrease in both the quantity and quality of saliva that eventually leads to xerostomia. Hyposalivation can increase susceptibility to dental caries, dental erosion, fungal and bacterial infections, digestive disorders, loss of taste, and difficulty in swallowing, which reduces the quality of life in patients. To date, no ideal medications have been available to treat hyposalivation and xerostomia effectively, and consequently, there is still a need for development of therapeutic agents and strategies. Recently, ductal irrigation and sialendoscopy of the parotid and submandibular glands have gained popularity for its efficacy as palliative treatments. In glandular irrigation, Stensen's ducts in the parotid glands and Wharton's ducts in the submandibular glands are irrigated with, for example, saline or corticosteroids by using a cannula. In sialendoscopy, endoscopes that are small enough to be introduced into the salivary ducts of the major salivary glands are utilized. Through these endoscopes, the ducts can be irrigated under direct visualization, blockages can be removed, and strictures can be dilated. An overview of both techniques and their efficacy in relieving symptoms of xerostomia and hyposalivation in patients with Sjögren's syndrome is presented

Altered nasal airflow: an unusual complication following implant surgery in the anterior maxilla

Dental implants have been in routine clinical use for over three decades and are a predictable treatment modality. However, as with all other aspects of dentistry, complications occur. A 50-year-old female patient with complaints of a long ongoing unpleasant altered nasal airflow presented herself at the VU University Medical Center Amsterdam. Visual inspection of the right nasal cavity revealed that the apical part of a dental implant placed in the upper right first incisor region had perforated the nasal floor and was partially protruding into the nasal cavity. Subsequent treatment consisted of a transnasal resection of the apical part of the dental implant to the level of the nasal floor. After a 12-month follow-up period, the patient reported having no altered nasal airflow. In conclusion, dental implants protruding into the nasal cavity can cause an alteration to the airflow. Furthermore, a partial removal of the apical part of the dental implant is a viable method of treating dental implants that extend into the nasal cavity

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

Controversies in ameloblastoma management: Evaluation of decision making, based on a retrospective analysis

Background: The ameloblastoma management is still challenging to the high recurrence rates and significant morbidity associated with radical treatment. The purpose of this 10-year retrospective study was to analyze the influence of ameloblastoma type and treatment strategy on the long-term outcomes and recurrence rates. Material and Methods: The retrospective analyses of 64 histologically-confirmed ameloblastoma cases was performed. The possible risk factors for recurrence and the development of complications were estimated statistically. Results: The treatment strategy applied for this group of patients was the following: thirty-four patients (53.1%) were treated conservatively with enucleation or extended bone curettage. Radical treatment (bone resection) was applied in 30 (46.9%) cases. The follow-up period ranged from 2 to 10 years (mean value 4.28 ± 3,26). General recurrence rate consisted 32.8%. This study did not find significant correlations between clinical or histopathological features of the ameloblastoma and the recurrence rate. The only factor that significantly influence recurrence rate was the treatment strategy (41% in conservative treatment vs 15% in radical treatment, p<0.05). Postoperative complications were observed in 42 patients (65.6%) and included face asymmetry and disfigurement (17.2%), temporary paresthesia of the inferior alveolar nerve (IAN)-23.4%, permanent paresthesia of IAN-20.3%, paresis of a marginal branch of the facial nerve-6.3%, infection 12.5%, and swelling-20.3%. The complication rates, esthetic and functional deficiency were significantly higher in radically treated patients (p<0.05) Conclusions: Our study confirms that higher recurrence rate is associated with conservative treatment for am-eloblastoma, while radical treatment leads to an increased number of postoperative complications that affect the patient's quality of life

A Novel Treatment Concept for Advanced Stage Mandibular Osteoradionecrosis Combining Isodose Curve Visualization and Nerve Preservation: A Prospective Pilot Study

Background: Osteoradionecrosis (ORN) of the mandible is a severe complication of radiation therapy in head and neck cancer patients. Treatment of advanced stage mandibular osteoradionecrosis may consist of segmental resection and osseous reconstruction, often sacrificing the inferior alveolar nerve (IAN). New computer-assisted surgery (CAS) techniques can be used for guided IAN preservation and 3D radiotherapy isodose curve visualization for patient specific mandibular resection margins. This study introduces a novel treatment concept combining these CAS techniques for treatment of advanced stage ORN. Methods: Our advanced stage ORN treatment concept includes consecutively: 1) determination of the mandibular resection margins using a 3D 50 Gy isodose curve visualization, 2) segmental mandibular resection with preservation of the IAN with a two-step cutting guide, and 3) 3D planned mandibular reconstruction using a hand-bent patient specific reconstruction plate. Postoperative accuracy of the mandibular reconstruction was evaluated using a guideline. Objective and subjective IAN sensory function was tested for a period of 12 months postoperatively. Results: Five patients with advanced stage ORN were treated with our ORN treatment concept using the fibula free flap. A total of seven IANs were salvaged in two men and three women. No complications occurred and all reconstructions healed properly. Neither non-union nor recurrence of ORN was observed. Sensory function of all IANs recovered after resection up to 100 percent, including the patients with a pathologic fracture due to ORN. The accuracy evaluation showed angle deviations limited to 3.78 degrees. Two deviations of 6.42° and 7.47° were found. After an average of 11,6 months all patients received dental implants to complete oral rehabilitation. Conclusions: Our novel ORN treatment concept shows promising results for implementation of 3D radiotherapy isodose curve visualization and IAN preservation. Sensory function of all IANs recovered after segmental mandibular resection

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