Endoscopic treatment of salivary glands affected by Sjögren Syndrome; A pilot study

Completed

• Conditions: Dry mouth disease; Sjögren Syndrome; 10003816

• Registration Number: NL-OMON40344
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- A diagnosed Syndrome of Sjögren (Eular guidelines)
- A remaining salivary flow
- Age > 18 years and < 70 years

Exclusion Criteria

- A complete lack of measurable salivary flow, also after stimulation of the glands by taste or chewing
- Acute sialadenitis
- Use of sialogogue medication (i.e. pilocarpine or cevimelin)
- Other severe illnesses or physical conditions that make a treatment under general anesthesia impossible or highly riskful

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in unstimulated whole mouth and<br /><br>stimulated parotid salivary flow in ml/min after sialendoscopic treatment, with<br /><br>or without rinsing with hydrocortisone, compared to baseline and compared to a<br /><br>non-treatment control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameters are the mouthfeel score (XI score), the ESSPRI and the<br /><br>CODS score</p><br>