NCT04990011

Unknown

Amnion Chorion Membrane and Oroantral Communication

Hams Hamed Abdelrahman Source

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Other study identifiers

Sponsor study identifier

amnion chorion-2019

Study Type

interventional

Estimated enrollment

10

Locations

1 country

Sites

1

Timeline

Study Start

September 1, 2020

Actual (reported)

Primary Completion

December 30, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 30, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 10 participants
Study completion date: December 30, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 1, 2020
Actual (reported)
First Submitted
July 8, 2021
Actual (reported)
First Posted
August 4, 2021
Actual (reported)
Primary Completion
December 30, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: August 4, 2021
Status Verified: July 2021
Last Update Submitted: July 26, 2021

Conditions

Oroantral Communication

Outcome Measures

Primary Outcomes (1)

success of surgery
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 Outcomes (2)

Pain level
12 hours
Change in bone formation
at 3rd, 6th months

Study Arms (1)

BioXclude amnion chorion membrane

EXPERIMENTAL

Procedure: BioXclude amnion chorion membrane

Interventions

BioXclude amnion chorion membraneProcedure

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.

BioXclude amnion chorion membrane

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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

Sponsors & Collaborators

Hams Hamed Abdelrahman
Otherlead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

Hala A El awamy, BDSCONTACT01028498333

Hala A El awamy, BDSPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

Oral FistulaMouth DiseasesStomatognathic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Hala A El awamy, BDS

CONTACT

01028498333 halaebeid07@gmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

July 8, 2021

First Posted

August 4, 2021

Study Start

September 1, 2020

Actual (reported)

Primary Completion

December 30, 2021

Estimated (date passed)

Good oral hygiene

You may not qualify if:

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

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 30, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

August 4, 2021

Record last verified: 2021-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT04990011
Data provider: ClinicalTrials.gov
Source updated: 2021-08-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:14 UTC

Locations

EG(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

BioXclude amnion chorion membrane

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations