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

Sponsor

Aya Sakr (Other)

Overall Status

Completed

CT.gov ID

NCT05346341

Collaborator

(none)

Enrollment

Location

Arm

13.2

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Salivary Gland Stone Salivary Gland Diseases	Procedure: Minimally invasive techniques	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 11, 2021

Actual Primary Completion Date :

Feb 10, 2022

Actual Study Completion Date :

Mar 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt	21527

Sponsors and Collaborators

Aya Sakr

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Sakr, Assistant Lecturer of Oral and Maxillofacial Surgery, Alexandria University

ClinicalTrials.gov Identifier:

NCT05346341

Other Study ID Numbers:

00010556 - 0008839

First Posted:

Apr 26, 2022

Last Update Posted:

Apr 26, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Salivary Gland Diseases

Salivary Gland Calculi

Salivary Calculi

Study Results

No Results Posted as of Apr 26, 2022