NCT04990011

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

July 8, 2021

Last Update Submit

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

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 .
  • 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.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

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

01028498333halaebeid07@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

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

August 4, 2021

Record last verified: 2021-07

Locations

EG(1)