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

Not Applicable

Completed

• Conditions: Salivary Gland Diseases; Salivary Gland Stone
• Interventions: Procedure: Minimally invasive techniques

• Registration Number: NCT05346341
• Lead Sponsor: Aya Sakr

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-11
• Primary Completion: 2022-02-10
• Study Completion: 2022-03-20
• Status Verified: 2022-04
• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally invasive techniques	Minimally invasive techniques	-

Primary Outcome Measures

Name	Time	Method
Objective salivary gland performance (salivary flow measurement)	up to 12 months	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.
Subjective salivary gland performance	up to 12 months	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt