CClinicalTrials.gg
Status unknownNCT04990011Updated Aug 4, 2021

Amnion Chorion Membrane and Oroantral Communication

An interventional study of BioXclude amnion chorion membrane in Oroantral Communication, sponsored by Hams Hamed Abdelrahman. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-08-04.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Sep 2020, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Oroantral Communication
03

In context

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    BioXclude amnion chorion membrane

    Procedure: 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.

06

What researchers measure

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

    Time frame: 1 month

Secondary outcomes

  1. Pain level

    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

    Time frame: 12 hours

  2. Change in bone formation

    Evaluation of bone formation at the communication site by computed tomography will be measured at 3 months and 6 months post operatively

    Time frame: at 3rd, 6th months

07

Study locations

1 of 1 sites recruiting
  • Alexandria Faculty of Dentistry
    Alexandria, Egypt
    • Hala A El awamy, BDS · Contact · 01028498333
    • Hala A El awamy, BDS · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04990011
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted
Aug 4, 2021
Start date
Sep 1, 2020
Primary completion
Dec 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Aug 4, 2021

Study contacts

Hala A El awamy, BDS
Contact
halaebeid07@gmail.com
01028498333 ext. 002

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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