Salivary Gland StoneNCT05346341
Evaluation of the Effect of Minimally Invasive Procedures Used in Management of Salivary Ductal Pathologies on Patients' Symptomatology and Gland Function
A study testing Minimally invasive techniques in people with Salivary Gland Stone and Salivary Gland Diseases, run by Aya Sakr at 1 site in Egypt.
Trial summary
Aim of the current study was to evaluate the minimally invasive techniques in the management of salivary gland ductal pathologies Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Salivary Gland Stone, Salivary Gland Diseases
- What is being tested?
- Minimally invasive techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Feb 2021to 20 Mar 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are unfit for surgery.
- Patients with previous submandibular or parotid surgical resection.
- Patients with salivary tumors either benign or malignant.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Minimally invasive techniques
- Medical subject headings
- Salivary Gland Calculi, Salivary Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive techniquesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive techniques | Experimental | Not described Receives: Procedure: Minimally invasive techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start11 Feb 2021
- Primary completion10 Feb 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Sakr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Sakr, Alexandria University
- Investigators
- Aya Sakr, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346341
- Sponsor's protocol ID
- 00010556 - 0008839
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No