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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40344

Enrollment

Registered

2014-03-17

Start date

2014-07-21

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry mouth disease Sjögren Syndrome

Interventions

in every participating volunteer a sialendoscopy of the parotid glands and submandibular glands is performed.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - A diagnosed Syndrome of Sjögren (Eular guidelines) - A remaining salivary flow - Age > 18 years and

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
The secondary parameters are the mouthfeel score (XI score), the ESSPRI and the CODS score	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)