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

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

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Key information

Conditions

Salivary Gland Stone Calculi Mouth Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Salivary Calculi Salivary Gland Calculi Salivary Gland Diseases Stomatognathic Diseases

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimally invasive techniques

Procedure

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.

Primary outcomes

Subjective salivary gland performance

Time frame: 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.
Objective salivary gland performance (salivary flow measurement)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aya Sakr

Other

Registry information

Official study 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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Apr 26, 2022
Registry last updated: Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed