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

NCT ID: NCT05407493

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oroantral Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Buccal flap

The buccal flap is slid over the fistula and sutured to the undermined palatal mucosa using horizontal mattress sutures.

No interventions assigned to this group

Double-layer

A combination between a buccal trapezoidal flap and a palatal connective pedicle flap.

No interventions assigned to this group

Buccal flap with L-PRF

A L-PRF plug is interposed between the fistula and the buccal sliding flap.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Siena

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nicola Discepoli

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicola Discepoli

Role: STUDY_DIRECTOR

University of Siena

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dipartimento di Odontostomatologia

Siena, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicola Baldini

Role: CONTACT

00393382809460

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nicola Baldini

Role: primary

3382809460

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ODO002, 26/06/2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Trial in Mini-invasive Pilonidal Sinus Disease Surgery
NCT06964763 ENROLLING_BY_INVITATION NA
Feasibility Study of a New Fistula Pouching System
NCT00294450 COMPLETED PHASE2/PHASE3