Skip to content

Evaluation of the Effect of Minimally Invasive Procedures Used in Management of Salivary Ductal Pathologies on Patients' Symptomatology and Gland Function

Evaluation of the Effect of Minimally Invasive Procedures Used in Management of Salivary Ductal Pathologies on Patients' Symptomatology and Gland Function - A Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05346341
Enrollment
31
Registered
2022-04-26
Start date
2021-02-11
Completion date
2022-03-20
Last updated
2022-04-26

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

Conditions

Salivary Gland Diseases, Salivary Gland Stone

Brief summary

Aim of the current study was to evaluate the minimally invasive techniques in the management of salivary gland ductal pathologies

Interventions

PROCEDUREMinimally invasive techniques

All patient will be treated under general anaesthesia An appropriate gland-preserving minimally-invasive surgical procedure will be performed for all patients according to the nature and extent of the disease for either submandibular or parotid ducts. Minimally invasive techniques for ductal salivary gland pathologies include: 1. Sialolithotomy through a simple cutdown 2. Sialendoscopy 3. Transoral microscopic-assisted sialolithotomy.

Sponsors

Aya Sakr
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Healthy volunteers
No

Inclusion criteria

* All patients manifesting with either submandibular or parotid salivary gland ductal pathologies including: * Sialolithiasis (salivary stones). * Salivary ductal stenosis or stricture. * Children with juvenile recurrent parotitis. * Sjogren's syndrome. * Radio-iodine induced sialadenitis.

Exclusion criteria

* Patients who are unfit for surgery. * Patients with previous submandibular or parotid surgical resection. * Patients with salivary tumors either benign or malignant.

Design outcomes

Primary

MeasureTime frameDescription
Subjective salivary gland performanceup to 12 monthsThis was done using a questionnaire to measure salivary score (this questionnaire is formulated by the multidisciplinary salivary gland society MSGS). The questionnaire consists of 20 questions divided in two groups: 13 regarding xerostomia and 7 regarding sialadenitis. Each question is scored from 0 to 10 and the total score could vary from 0 to 200 points.
Objective salivary gland performance (salivary flow measurement)up to 12 monthsWe have chosen 6 minutes as our standard time to collect saliva and we have chosen on purpose to collect saliva separately from the two parotids and jointly from the submandibular gland. A 5cmx5cm gaze is applied on the papilla of each Stenson duct and a third one is placed under the tongue. All these tampons are weighted separately after 6 minutes and the results collected.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026