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

NCT05346341 | Completed

• 1 other identifier: 00010556 - 0008839
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Salivary Gland Stone; Salivary Gland Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 12 months

• 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.

  up to 12 months

Study Arms (1)

Minimally invasive techniques

EXPERIMENTAL

Procedure: Minimally invasive techniques

Interventions

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

Minimally invasive techniques

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are unfit for surgery.
• Patients with previous submandibular or parotid surgical resection.
• Patients with salivary tumors either benign or malignant.

Sponsors & Collaborators

• Aya Sakr: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

MeSH Terms

Conditions

Salivary Gland Calculi; Salivary Gland Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Aya Sakr, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: February 11, 2021
• Primary Completion: February 10, 2022
• Study Completion: March 20, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

EG (1)