Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

NCT ID: NCT02112019

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-12-31

Brief Summary

Sjögren's syndrome (SS) is an autoimmune inflammatory disorder of the exocrine glands. It particularly affects the lacrimal and salivary glands. Severe dry mouth and eyes are frequently reported as presenting symptoms. These symptoms are in many cases accompanied by nonspecific symptoms, such as malaise and fatigue. In addition, extraglandular manifestations, like purpura, polyneuropathy, and arthritis, can be present. SS affects mainly women with a female/male ratio of 9:1 and can occur at all ages. Due to the irreversible damage to the saliva producing cells, the quantity and quality of saliva reduces. The progressive nature of the syndrome results in a further reduction of salivary flow. Due to hyposalivation the patients suffer from progressive dental decay, dental erosion, severe dry mouth complaints (i.e. eating and swallowing problems, lack of taste), inflammation of the oral mucosa and lack of retention of removable dentures. Overall, this can be qualified as a reduction in the quality of life. Until now no effective (palliative) therapy to relieve dry mouth complaints is available. A recent case series study suggests that an endoscopic technique (sialoendoscopy) is able to alleviate the symptoms of patients suffering from SS. In this technique the ducts of the salivary glands are rinsed with saline and cortisone and possible strictures are dilated. It is hypothesised that performing a sialoendoscopic treatment will raise or restore (un)stimulated salivary flow levels and improve the reported mouthfeel score.

Conditions

Sjögren's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Sialoendoscopy with saline

By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated

Group Type: EXPERIMENTAL

Sialoendoscopy

Intervention Type: PROCEDURE

saline

Intervention Type: DRUG

Sialoendoscopy: saline and hydrocortisone

By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated

Group Type: ACTIVE_COMPARATOR

Sialoendoscopy

Intervention Type: PROCEDURE

saline

Intervention Type: DRUG

hydrocortisone

Intervention Type: DRUG

Control: no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sialoendoscopy

Intervention Type: PROCEDURE

saline

Intervention Type: DRUG

hydrocortisone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A diagnosed (by the European League Against Rheumatism guidelines) primary or secondary Syndrome of Sjögren
• Age: > 18 years and < 70 years
• A remaining salivary flow

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 cevimeline)
• Other severe illnesses or physical conditions that make a treatment under general anesthesia impossible or highly riskful.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Derk Jan Jager

OTHER

Sponsor Role: lead

Responsible Party

Derk Jan Jager

DMD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

VU Medical Center department of Maxillofacial surgery

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

NL44018.029.13

Identifier Type: -

Identifier Source: org_study_id