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Clinical Trials/NCT05407493
NCT05407493
Unknown
Not Applicable

Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication

University of Siena1 site in 1 country60 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oroantral Fistula
Sponsor
University of Siena
Enrollment
60
Locations
1
Primary Endpoint
Closure success
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicola Discepoli

Prof

University of Siena

Eligibility Criteria

Inclusion Criteria

  • Eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) .

Exclusion Criteria

  • i) received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.

Outcomes

Primary Outcomes

Closure success

Time Frame: One month after surgery

Measured with probing and Valsalva test

Secondary Outcomes

  • Patient reported Pain(Each week for one month)

Study Sites (1)

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