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Clinical Trials/NCT05346341
NCT05346341
Completed
Not Applicable

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

Aya Sakr1 site in 1 country31 target enrollmentFebruary 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Salivary Gland Stone
Sponsor
Aya Sakr
Enrollment
31
Locations
1
Primary Endpoint
Objective salivary gland performance (salivary flow measurement)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 11, 2021
End Date
March 20, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group

Investigators

Sponsor
Aya Sakr
Responsible Party
Sponsor Investigator
Principal Investigator

Aya Sakr

Assistant Lecturer of Oral and Maxillofacial Surgery

Alexandria University

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.

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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