Amnion Chorion Membrane and Oroantral Communication

Not Applicable

• Conditions: Oroantral Communication
• Interventions: Procedure: BioXclude amnion chorion membrane

• Registration Number: NCT04990011
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BioXclude amnion chorion membrane	BioXclude amnion chorion membrane	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt