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

Salivary Gland Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346341
• Other study ID #: 00010556 - 0008839
• Status: Completed
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: March 20, 2022

Study information

• Verified date: April 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 20, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Salivary Gland Diseases

Intervention

Procedure:
• Minimally 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: Sialolithotomy through a simple cutdown Sialendoscopy Transoral microscopic-assisted sialolithotomy.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Aya Sakr

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective salivary gland performance	This 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.	up to 12 months
Primary	Objective salivary gland performance (salivary flow measurement)	We 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.	up to 12 months