Oroantral CommunicationNCT04990011
Amnion Chorion Membrane and Oroantral Communication
A study testing BioXclude amnion chorion membrane in people with Oroantral Communication, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Oroantral Communication
- What is being tested?
- BioXclude amnion chorion membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients should be free of any relevant systemic diseases.
- Patients with recent oroantral communication (O.A.C) (24:72) hours .
- Good oral hygiene
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Hala A El awamy, BDS, 01028498333
Hala A El awamy, BDS
About this study
Official title: Evaluation of Amnion Chorion Membrane in the Repair of Oro Antral Communication
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.
- Conditions
- Oroantral Communication
- Being tested
- BioXclude amnion chorion membrane
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioXclude amnion chorion membraneProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| BioXclude amnion chorion membrane | Experimental | Not described Receives: Procedure: BioXclude amnion chorion membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (2)
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
Measured: 12 hours
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
Measured: at 3rd, 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Sep 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oroantral CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990011
- Sponsor's protocol ID
- amnion chorion-2019
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Amnion Chorion Membrane in the Repair of Oro Antral Communication
- ClinicalTrials.gov ID
- NCT04990011
- Acronym / sponsor ID
- amnion chorion-2019
- Conditions
- Oroantral Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioXclude amnion chorion membrane | Experimental | Procedure: BioXclude amnion chorion membrane |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients should be free of any relevant systemic diseases.
- Patients with recent oroantral communication (O.A.C) (24:72) hours .
- Good oral hygiene
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioXclude amnion chorion membraneThe 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. | Procedure or surgery | BioXclude amnion chorion membrane |
Primary outcome
success of surgery
Time frame: 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
2 secondary outcomes
Pain level
Time frame: 12 hours
Change in bone formation
Time frame: at 3rd, 6th months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioXclude amnion chorion membrane in people with Oroantral Communication, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala A El awamy, BDS (01028498333 ext. 002, halaebeid07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of surgery (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.