Amnion Chorion Membrane and Oroantral Communication
Primary Purpose
Oroantral Communication
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
BioXclude amnion chorion membrane
Sponsored by
About this trial
This is an interventional treatment trial for Oroantral Communication
Eligibility Criteria
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
Sites / Locations
- Alexandria Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BioXclude amnion chorion membrane
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04990011
Brief Title
Amnion Chorion Membrane and Oroantral Communication
Official Title
Evaluation of Amnion Chorion Membrane in the Repair of Oro Antral Communication
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oroantral Communication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BioXclude amnion chorion membrane
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
BioXclude amnion chorion membrane
Intervention Description
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.
Primary Outcome Measure Information:
Title
success of surgery
Description
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 Outcome Measure Information:
Title
Pain level
Description
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
Title
Change in bone formation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hala A El awamy, BDS
Phone
01028498333
Ext
002
Email
halaebeid07@gmail.com
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala A El awamy, BDS
Phone
01028498333
First Name & Middle Initial & Last Name & Degree
Hala A El awamy, BDS
12. IPD Sharing Statement
Learn more about this trial
Amnion Chorion Membrane and Oroantral Communication
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