- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277959
Marsupialization of Odontogenic Cysts
December 10, 2025 updated by: Batool Abdulnasser Ismail, University Of Anbar
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ramadi, Iraq
- University of Anbar-college of dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Pathological diagnosis of odontogenic cyst
- Indicated for marsupialization
- Patients aged from 15 to 60 years
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
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.
|
Time Frame: 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.
|
Time Frame: 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2025
Primary Completion (Actual)
October 10, 2025
Study Completion (Actual)
October 20, 2025
Study Registration Dates
First Submitted
November 28, 2025
First Submitted That Met QC Criteria
December 10, 2025
First Posted (Actual)
December 11, 2025
Study Record Updates
Last Update Posted (Actual)
December 11, 2025
Last Update Submitted That Met QC Criteria
December 10, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Ref. 236, in 25-12-2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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