Marsupialization of Odontogenic Cysts

NCT07277959 | Completed DMC

• 1 other identifier: Ref. 236, in 25-12-2024
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Odontogenic Cysts Marsupialization

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• Patient Satisfaction

  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

  The presence of postoperative complications (infection, device displacement, or soft tissue overgrowth) will be recorded clinically at follow-up visits.

  Time Frame: 6 months

Interventions

novel use of Grommet tube DEVICE

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

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Pathological diagnosis of odontogenic cyst
• Indicated for marsupialization
• Patients aged from 15 to 60 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Of Anbar: lead

Study Sites (1)

University of Anbar-college of dentistry

Ramadi, Iraq

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student, Department of Oral Surgery

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: January 2, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 20, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-01

Locations

IR (1)