Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 7, 2022
June 1, 2022
4.9 years
June 1, 2022
June 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Closure success
Measured with probing and Valsalva test
One month after surgery
Secondary Outcomes (1)
Patient reported Pain
Each week for one month
Study Arms (3)
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.
Eligibility Criteria
Eligible patients with a clinical diagnosis of oroantral fistula among those referring to the Dental department of Siena University Hospital
You may qualify if:
- 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) .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dipartimento di Odontostomatologia
Siena, 53100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicola Discepoli
University of Siena
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
June 1, 2022
First Posted
June 7, 2022
Study Start
January 1, 2018
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
June 7, 2022
Record last verified: 2022-06