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

Sponsor
University of Siena (Other)
Overall Status
Recruiting
CT.gov ID
NCT05407493
Collaborator
(none)
60
Enrollment
1
Location
71
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication
    Actual Study Start Date :
    Jan 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Closure success [One month after surgery]

      Measured with probing and Valsalva test

    Secondary Outcome Measures

    1. Patient reported Pain [Each week for one month]

      Pain on a VAS scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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:
    1. received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy
    2. had systemic diseases that could interfere with oral tissue healing process/bleeding
    3. were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dipartimento di Odontostomatologia Siena Italy 53100

    Sponsors and Collaborators

    • University of Siena

    Investigators

    • Study Director: Nicola Discepoli, University of Siena

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicola Discepoli, Prof, University of Siena
    ClinicalTrials.gov Identifier:
    NCT05407493
    Other Study ID Numbers:
    • ODO002, 26/06/2020
    First Posted:
    Jun 7, 2022
    Last Update Posted:
    Jun 7, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Oroantral Fistula
    Fistula

    Study Results

    No Results Posted as of Jun 7, 2022