Back to resultsA Modified Approach for the Closure of Oral Sinus Communications
Primary Purpose
Surgery Site Fistula
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
modified buccal flap and subepithelial connective palatal flap
Sponsored by
About this trial
This is an interventional treatment trial for Surgery Site Fistula focused on measuring Extraction, Oro-antral communication, Oro-antral fistula
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
Sites / Locations
- University of Siena- Department of medical biotechnologies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
modified buccal flap and subepithelial connective palatal flap
Arm Description
Outcomes
Primary Outcome Measures
Closure of the communication
Clinical observation
Secondary Outcome Measures
Pain and discomfort
These parameters are described using VAS technique
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04499144
Brief Title
A Modified Approach for the Closure of Oral Sinus Communications
Official Title
A Modified Approach for the Closure of Oral Sinus Communications
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
July 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Siena
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery Site Fistula
Keywords
Extraction, Oro-antral communication, Oro-antral fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
case series of a new surgical design
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
modified buccal flap and subepithelial connective palatal flap
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
modified buccal flap and subepithelial connective palatal flap
Intervention Description
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 Outcome Measure Information:
Title
Closure of the communication
Description
Clinical observation
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Pain and discomfort
Description
These parameters are described using VAS technique
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Habib, Dr.
Organizational Affiliation
University of Siena
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Siena- Department of medical biotechnologies
City
Siena
ZIP/Postal Code
53100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Modified Approach for the Closure of Oral Sinus Communications
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