Amnion Chorion Membrane and Oroantral Communication

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04990011

Enrollment

Registered

2021-08-04

Start date

2020-09-01

Completion date

2021-12-30

Last updated

2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oroantral Communication

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.

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.

Interventions

PROCEDUREBioXclude 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
success of surgery	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

Secondary

Measure	Time frame	Description
Pain level	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
Change in bone formation	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

Countries

Egypt

Contacts

Primary ContactHala A El awamy, BDS

halaebeid07@gmail.com01028498333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026