A Modified Approach for the Closure of Oral Sinus Communications

Not Applicable

Completed

• Conditions: Surgery Site Fistula
• Interventions: Procedure: modified buccal flap and subepithelial connective palatal flap

• Registration Number: NCT04499144
• Lead Sponsor: University of Siena

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-26
• Primary Completion: 2020-06-29
• Study Completion: 2020-07-27
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Status Verified: 2020-08
• Study First Posted: 2020-08-05
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
modified buccal flap and subepithelial connective palatal flap	modified buccal flap and subepithelial connective palatal flap	-

Primary Outcome Measures

Name	Time	Method
Closure of the communication	Day 30	Clinical observation

Secondary Outcome Measures

Name	Time	Method
Pain and discomfort	Day 30	These parameters are described using VAS technique

Trial Locations

Locations (1)

University of Siena- Department of medical biotechnologies; 🇮🇹 Siena, Italy