Effect of sialendoscopy with intraductal steroid plus pilocarpine for treatment of sialadenitis associated with Sjogren syndrome

Effect of sialendoscopy with intraductal steroid alone versus intraductal steroid plus pilocarpine therapy for sialadenitis associated with Sjogren syndrome : a 8-week follow-up, double-blind, randomized, controlled trial

Status

Unknown

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240214001

Enrollment

Registered

2024-02-14

Start date

2024-02-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Sialadenitis associated with Sjogren syndrome Sjogren syndrome Sialadenitis Sialendoscopy Steroid Pilocarpine

Interventions

local anesthesia with sialendoscopy with intraductal methyprednisolone 40 mg in each parotid gland ,local anesthesia with sialendoscopy with intraductal methyprednisolone 40 mg in each parotid gland p

Active Comparator Drug,Active Comparator Drug

sialendoscopy with intraductal methyprednisolone alone ,sialendoscopy with intraductal methyprednisolone plus pilocarpine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Sjogren syndrome was diagnosed with the 2002 AECG classification criteria 3. Baseline UWS >0.0 ml/min or evidence of glandular reserve function (SWS 0.02 ml/ min) 4. Stable immunosuppressive drugs 8 weeks before enrollment

Exclusion criteria

Exclusion criteria: 1. Severe critical illness 2. History of head or neck radiotherapy 3. A physical condition that did not allow the use of localized anesthesia during treatment 4. Concurrent use of sialogogue 5. History of drug (steroid, pilocarpine, anesthetic drug) allergy

Design outcomes

Primary

Measure	Time frame
salivary flow 1 and 8 week after intervention Unstimulated whole salivary flow (UWS) and stimulated whole salivary flow (SWS)	—

Secondary

Measure	Time frame
xerostomic symptoms 1 and 8 weeks after intervention Xerostomic acores (CODS, XI and ESSPRI)	—

Countries

Thailand

Contacts

Public ContactPannisa Kaiwanarporn

Faculty of Medicine Ramathibodi Hospital, Mahidol University

bee_barbie4@hotmail.com0892640073

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026