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

Primary Purpose

Salivary Gland Stone, Salivary Gland Diseases

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Minimally invasive techniques

About this trial

This is an interventional treatment trial for Salivary Gland Stone

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minimally invasive techniques

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05346341

First Posted

April 20, 2022

Last Updated

April 20, 2022

Sponsor

Aya Sakr

1. Study Identification

Unique Protocol Identification Number

NCT05346341

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

February 11, 2021 (Actual)

Primary Completion Date

February 10, 2022 (Actual)

Study Completion Date

March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Aya Sakr

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Salivary Gland Stone, Salivary Gland Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minimally invasive techniques

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Minimally invasive techniques

Intervention Description

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 Outcome Measure Information:

Title

Subjective salivary gland performance

Description

Time Frame

up to 12 months

Title

Objective salivary gland performance (salivary flow measurement)

Description

Time Frame

up to 12 months

10. Eligibility

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aya Sakr, M.Sc

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry, Alexandria University

City

Alexandria

ZIP/Postal Code

21527

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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