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

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.

Study Overview

• Status: Recruiting
• Conditions: Oroantral Fistula

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Nicola Baldini; Phone Number: 00393382809460; Email: baldini.nicola@gmail.com

Study Locations

• Italy
  • Siena, Italy, 53100
    • Recruiting
    • Dipartimento di Odontostomatologia
    • Contact: Nicola Baldini; Phone Number: 3382809460; Email: baldini.nicola@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eligible patients with a clinical diagnosis of oroantral fistula among those referring to the Dental department of Siena University Hospital

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Buccal flap; The buccal flap is slid over the fistula and sutured to the undermined palatal mucosa using horizontal mattress sutures.
Double-layer; A combination between a buccal trapezoidal flap and a palatal connective pedicle flap.
Buccal flap with L-PRF; A L-PRF plug is interposed between the fistula and the buccal sliding flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Closure success	Measured with probing and Valsalva test	One month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported Pain	Pain on a VAS scale	Each week for one month

Collaborators and Investigators

• Sponsor: University of Siena
• Investigators: Study Director: Nicola Discepoli, University of Siena

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Oral Fistula; Fistula; Oroantral Fistula
• Other Study ID Numbers: ODO002, 26/06/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No