Pathology
Sialendoscopy of Salivary Glands Affected by Sjögren Syndrome: A Randomized Controlled Pilot Study

https://doi.org/10.1016/j.joms.2015.12.019Get rights and content

Purpose

Sialendoscopy of the major salivary glands could alleviate the oral symptoms of Sjögren syndrome (SS) and restore salivary function. The aim of this pilot study was to evaluate the effect of sialendoscopy of the major salivary glands on salivary flow, saliva composition, and mouthfeel in patients with SS and to collect data for sample size analysis for a larger clinical trial.

Materials and Methods

Twenty patients diagnosed with SS were randomly assigned to a nonintervention control group or a sialendoscopy group. Unstimulated whole saliva flow, stimulated whole saliva flow, Clinical Oral Dryness Score, Xerostomia Inventory score, and EULAR Sjögren's Syndrome Patient Reported Index score were obtained 1 week before (T0), 1 week after (T2), and 8 weeks after (T3) sialendoscopy. Unstimulated whole saliva was analyzed for amylase concentration, activity, and mucin 5B concentration. Amylase and mucin 5B output were calculated.

Results

In the sialendoscopy group, unstimulated and stimulated whole saliva flows were numerically higher at T2 and T3 compared with T0. Xerostomia Inventory score was significantly lower in the sialendoscopy group at T2 compared with T0 (P = .03). Unstimulated and stimulated whole saliva flows were higher in the sialendoscopy group compared with the control group at T2 and T3 (not meaningful). Significant differences were found between groups for the EULAR Sjögren's Syndrome Patient Reported Index score at T2 (P = .03) and T3 (P = .001). Xerostomia Inventory score and Clinical Oral Dryness Score in the sialendoscopy group were lower compared with the control group at T2 (P = .02) and at T3 (P = .04), indicating less oral dryness.

Conclusion

This pilot study indicates a positive effect of sialendoscopy on some parameters, but it cannot yet be concluded that it has a positive effect on salivary flow in patients with SS. These preliminary results need to be verified in a randomized controlled trial with a larger sample and longer follow-up period.

Section snippets

Study Population

Patients with SS were recruited from the Center for Special Care Dentistry (Amsterdam, The Netherlands) and through the Dutch Sjögren's Patients Federation. Written consent was obtained from each patient. Patients with primary and secondary SS 18 to 75 years of age were included. All patients fulfilled the American-European Consensus Group Classification Criteria for SS.14 Patients with acute sialadenitis, severe illness, or physical conditions making treatment under general anesthesia

Results

For this pilot study, data from 20 patients were used (Fig 1). The mean age was 56.6 years (range, 36 to 70 yr). All patients were women. Analysis of the data for normality showed that the XI, ESSPRI, CODS, MUC5B, and amylase concentration were normally distributed. UWS, SWS, MUC5B, and amylase output did not show a normal distribution (P < .001 by Shapiro-Wilk test).

The mean UWS and SWS were numerically higher at T2 and T3 compared with T0 in the intervention group (not meaningful). In the

Discussion

This trial investigated whether sialendoscopy of the major salivary glands could restore salivary function and thereby decrease dry mouth complaints of patients with SS. The results of the present pilot study suggest that sialendoscopy could have a positive effect on objective and subjective oral dryness measurements and patient-reported SS symptoms. No strong evidence was found that sialendoscopy could induce an increase in salivary flow, because this effect was not important.

Currently, there

Acknowledgments

The authors thank Marina Šumić and Tamana Alokozai for their assistance in the biochemical analyses and Karl Storz GmbH & Co for loaning the sialendoscopy sets and endoscopic video unit.

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