Odontogenic Cysts MarsupializationNCT07277959
Marsupialization of Odontogenic Cysts
An observational study of Odontogenic Cysts Marsupialization, run by University Of Anbar at 1 site in Iraq.
Trial summary
To evaluate the efficacy of the Grommet tube by measuring the rate of reduction in cyst size, assess patients satisfaction, and evaluate the occurrence of complications. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Odontogenic Cysts Marsupialization
- What is being tested?
- novel use of Grommet tube
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteIraq
- Study dates
- 2 Jan 2025to 20 Oct 2025
- Phase
- Observational
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The group of patients in this study consisted of individuals diagnosed with odontogenic cysts who are indicated for marsupialization procedure. Ten patients were enrolled in this study.
Who may be able to join
- Pathological diagnosis of odontogenic cyst
- Indicated for marsupialization
- Patients aged from 15 to 60 years
Who cannot join
- Soft tissue cysts.
- Patients with systemic diseases affecting bone healing.
- Patients non-compliance with follow up visits.
- Patients with a history of neck and head radiotherapy or patients on chemotherapy.
- Patients taking antiresorptive drugs or corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Use of Grommet Tube in the Treatment of Odontogenic Cysts Marsupialization
To evaluate the efficacy of the Grommet tube by measuring the rate of reduction in cyst size, assess patients satisfaction, and evaluate the occurrence of complications.
- Conditions
- Odontogenic Cysts Marsupialization
- Being tested
- novel use of Grommet tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel use of Grommet tubeDevice
The intervention consisted of performing conventional marsupialization of the odontogenic cyst followed by the novel placement of a ventilation Grommet tube to maintain long-term patency of the surgical window. After administration of local anesthesia, a small bony window was created over the thinnest cortical area of the cyst to expose the cystic cavity. The cyst lining was incised then the tube was placed
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Cyst Size
Cyst volume will be measured using CBCT and 3D Slicer segmentation at baseline and 6 months after marsupialization. Percentage reduction in cyst size will be calculated.
Measured: 6 months
Patient Satisfaction
Patient satisfaction will be assessed using a validated questionnaire (e.g., 3-point Likert scale) at 6 months.
Measured: Time Frame: 6 months
Occurrence of Complications
The presence of postoperative complications (infection, device displacement, or soft tissue overgrowth) will be recorded clinically at follow-up visits.
Measured: Time Frame: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start2 Jan 2025
- Primary completion10 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontogenic Cysts MarsupializationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Anbar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Batool Abdulnasser Ismail, University Of Anbar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277959
- Sponsor's protocol ID
- Ref. 236, in 25-12-2024
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of Grommet Tube in the Treatment of Odontogenic Cysts Marsupialization
- ClinicalTrials.gov ID
- NCT07277959
- Acronym / sponsor ID
- Ref. 236, in 25-12-2024
- Conditions
- Odontogenic Cysts Marsupialization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Of AnbarUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 11 Dec 2025 (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.
To evaluate the efficacy of the Grommet tube by measuring the rate of reduction in cyst size, assess patients satisfaction, and evaluate the occurrence of complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The group of patients in this study consisted of individuals diagnosed with odontogenic cysts who are indicated for marsupialization procedure. Ten patients were enrolled in this study.
Key inclusion criteria (3 listed)
- Pathological diagnosis of odontogenic cyst
- Indicated for marsupialization
- Patients aged from 15 to 60 years
Key exclusion criteria (5 listed)
- Soft tissue cysts.
- Patients with systemic diseases affecting bone healing.
- Patients non-compliance with follow up visits.
- Patients with a history of neck and head radiotherapy or patients on chemotherapy.
- Patients taking antiresorptive drugs or corticosteroids.
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 |
|---|---|---|
| novel use of Grommet tubeThe intervention consisted of performing conventional marsupialization of the odontogenic cyst followed by the novel placement of a ventilation Grommet tube to maintain long-term patency of the surgical window. After administration of local anesthesia, a small bony window was created over the thinnest cortical area of the cyst to expose the cystic cavity. The cyst lining was incised then the tube was placed | Device | – |
Primary outcome
Reduction in Cyst Size
Time frame: 6 months
Cyst volume will be measured using CBCT and 3D Slicer segmentation at baseline and 6 months after marsupialization. Percentage reduction in cyst size will be calculated.
Patient Satisfaction
Time frame: Time Frame: 6 months
Patient satisfaction will be assessed using a validated questionnaire (e.g., 3-point Likert scale) at 6 months.
Occurrence of Complications
Time frame: Time Frame: 6 months
The presence of postoperative complications (infection, device displacement, or soft tissue overgrowth) will be recorded clinically at follow-up visits.
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 11 Dec 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Odontogenic Cysts Marsupialization, run by University Of Anbar at 1 site in Iraq.
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 3 inclusion and 5 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 11 Dec 2025. 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 Iraq. 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?
Reduction in Cyst Size (time frame: 6 months). The study lists 3 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 11 Dec 2025.