A Modified Approach for the Closure of Oral Sinus Communications

NCT ID: NCT04499144

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-26
• Study Completion Date: 2020-07-27

Brief 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

Conditions

Surgery Site Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

modified buccal flap and subepithelial connective palatal flap

Group Type: EXPERIMENTAL

modified buccal flap and subepithelial connective palatal flap

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Ralph Habib

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralph Habib, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Siena

Locations

University of Siena- Department of medical biotechnologies

Siena, , Italy

Countries

Italy

Other Identifiers

ODO002

Identifier Type: -

Identifier Source: org_study_id