A Modified Approach for the Closure of Oral Sinus Communications

Surgery Site Fistula Clinical Trial

Official title:

A Modified Approach for the Closure of Oral Sinus Communications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499144
• Other study ID #: ODO002
• Status: Completed
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: July 27, 2020

Study information

• Verified date: August 2020
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to describe a modified surgical approach for the closure of oral sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap rotated from the palate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 27, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with diagnosis of Oro-antral communication

• Patients with adequate radiographic status

• Patients who read and signed the informed consent

• Patients without periodontal disease

• Patients=18

Exclusion Criteria:

• Pregnancy or breastfeeding patients

• Patients compliance and patients with mental disorders

• Patients with diabetes

• Patients with osteonecrosis

• Patients with head and neck cancer

Related Conditions & MeSH terms

• Fistula
• Surgery Site Fistula

Intervention

Procedure:
• modified buccal flap and subepithelial connective palatal flap
The connective flap was harvested from the deeper area of the palatal mucosa. Pedicle flap dimensions were reported using the periodontal probe. The flap was then rotated to cover the oro antral communication (OAC) area. The rotation could be in mesial or distal direction, related to OAC position and for the convenience of the donor site. The connective palatal flap was sutured to the buccal periostium using mattress sutures.

Locations

Country	Name	City	State
Italy	University of Siena- Department of medical biotechnologies	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of the communication	Clinical observation	Day 30
Secondary	Pain and discomfort	These parameters are described using VAS technique	Day 30