A Modified Approach for the Closure of Oral Sinus Communications

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

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Key information

Conditions

Surgery Site Fistula Fistula Mouth Diseases Oral Fistula Oroantral Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Siena- Department of medical biotechnologies

Siena, 53100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

modified buccal flap and subepithelial connective palatal flap

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.

Primary outcomes

Closure of the communication

Time frame: Day 30

Clinical observation

Secondary outcomes

Pain and discomfort

Time frame: Day 30

These parameters are described using VAS technique

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Aug 5, 2020
Registry last updated: Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed