Efficacy of Buccal Pad of Fat, Advanced Platelet Rich Fibrin, Fibrin Glue and Oxidized Cellulose Plug in Management of Oro-Antral Communication, Comparative Clinical Study (OAC)

January 13, 2024 updated by: Nermine Ramadan Mahmoud, October 6 University
Evaluation of the efficacy of different treatment protocols in the management of Oro-Antral Communications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the current study was carried on 24 patients suffering from Oro-Antral Communications. All patients were divided into 4 equal groups.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12566
        • October 6U

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients suffering from oroantral communications
  • patients suffering from oroantral fistula.
  • The Diameter of the opening ranged from 4-9 mm,
  • communication resulted from recent extraction,
  • foreign body; or
  • cyst enucleation

Exclusion Criteria:

Patients suffering from any systemic diseases were excluded from the study.

  • diabetes,
  • autoimmune diseases,
  • cancers,
  • nephropathy,
  • coagulation disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
patients were treated using Buccal Pad of Fat for management of OAC.
Procedure: Buccal Pad of Fat
surgical procedure
Active Comparator: Group II
patients were treated using A-PRF technique for management of OAC.
Procedure: A-PRF
blood sample
Active Comparator: Group III
patients were treated with Fibrin Glue for management of OAC.
Procedure: fibrin glue
procedure
Active Comparator: Group IV
oxidized regenerated cellulose plug have been used for management of OAC.
Procedure: oxidized cellulose
procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
o Recurrence
Time Frame: 6 months
presence or absence
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain, visual analog scale
Time Frame: 4 weeks
0 no pain, 10 severe pain
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

January 13, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECO6U/19-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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