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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05346341
- Acronym / sponsor ID
- 00010556 - 0008839
- Conditions
- Salivary Gland Stone, Salivary Gland Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Aya SakrUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the current study was to evaluate the minimally invasive techniques in the management of salivary gland ductal pathologies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive techniques | Experimental | Procedure: Minimally invasive techniques |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who are unfit for surgery.
- Patients with previous submandibular or parotid surgical resection.
- Patients with salivary tumors either benign or malignant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive techniquesAll 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. | Procedure or surgery | Minimally invasive techniques |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aya Sakr, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective salivary gland performance (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.