Salivary Gland Diseases Clinical Trial
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
Verified date | April 2022 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim of the current study was to evaluate the minimally invasive techniques in the management of salivary gland ductal pathologies
Status | Completed |
Enrollment | 31 |
Est. completion date | March 20, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Aya Sakr |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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