Amnion Chorion Membrane and Oroantral Communication

July 26, 2021 updated by: Hams Hamed Abdelrahman

Evaluation of Amnion Chorion Membrane in the Repair of Oro Antral Communication

An oroantral communication is a relatively common yet, serious complication following the extraction of posterior maxillary teeth because of their close relationship to the maxillary sinus.

Several surgical techniques exist for the repair of oroantral communication, including local and free flaps, tissue expansion, allogenic tissue, and biomaterials.

The present study aims to evaluate the use of the BioXclude amnion chorion membrane in the repair of oroantral communication.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be performed on ten patients who have oroantral communication after extracting posterior maxillary teeth. The oroantral communication will be repaired by using the BioXclude amnion chorion membrane.

Study Type

Interventional

Enrollment (Anticipated)

10

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 Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria Faculty of Dentistry
        • Contact:
          • Hala A El awamy, BDS
          • Phone Number: 01028498333
        • Principal Investigator:
          • Hala A El awamy, BDS

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should be free of any relevant systemic diseases.
  • Patients with recent oroantral communication (O.A.C) (24:72) hours .
  • Good oral hygiene

Exclusion Criteria:

  • An immune compromised state.
  • Previous sinus disease.
  • History of sinus surgery.
  • Presence of intra-antral foreign bodies and need for cold well-luc procedure.
  • Presence of intra-sinus pathology

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioXclude amnion chorion membrane
Procedure: BioXclude amnion chorion membrane
The OAC will be closed by the Bioxclude ACM Amnion chorion membrane which is applied over the extraction socket then supported with a buccal advanced flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of surgery
Time Frame: 1 month
Surgery will be considered successful in case of negative nose-blowing 1-month postoperatively, absence of infection, absence of dehiscence or other healing complication
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: 12 hours
Post-operative pain measure by patients rating 12 h after surgery using visual analogue scale (VAS) of 100 unit on three-point scale with: 0-34 as mild pain, 35 - 64 as moderate pain and 65 - 100 as severe pain
12 hours
Change in bone formation
Time Frame: at 3rd, 6th months
Evaluation of bone formation at the communication site by computed tomography will be measured at 3 months and 6 months post operatively
at 3rd, 6th months

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

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)

September 1, 2020

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • amnion chorion-2019

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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