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

April 20, 2022 updated by: Aya Sakr

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21527
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Minimally invasive techniques
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:

  1. Sialolithotomy through a simple cutdown
  2. Sialendoscopy
  3. Transoral microscopic-assisted sialolithotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aya Sakr

Investigators

  • Principal Investigator: Aya Sakr, M.Sc, Faculty of Dentistry, Alexandria University, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 11, 2021

Primary Completion (ACTUAL)

February 10, 2022

Study Completion (ACTUAL)

March 20, 2022

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (ACTUAL)

April 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00010556 - 0008839

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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