Healthy Volunteers OnlyOACNCT06220877
Efficacy of Buccal Pad of Fat, Advanced Platelet Rich Fibrin, Fibrin Glue and Oxidized Cellulose Plug in Management of Oro-Antral Communication, Comparative Clinical Study
A study testing Buccal Pad of Fat, A-PRF and fibrin glue in people with Healthy Volunteers Only, run by October 6 University at 1 site in Egypt.
Trial summary
Evaluation of the efficacy of different treatment protocols in the management of Oro-Antral Communications. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Only
- What is being tested?
- Buccal Pad of Fat, A-PRF and fibrin glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jun 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients suffering from oroantral communications
- patients suffering from oroantral fistula.
- The Diameter of the opening ranged from 4-9 mm,
- communication resulted from recent extraction,
- foreign body; or
- cyst enucleation
Who cannot join
- Patients suffering from any systemic diseases were excluded from the study.
- diabetes,
- autoimmune diseases,
- cancers,
- nephropathy,
- coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the efficacy of different treatment protocols in the management of Oro-Antral Communications.
Read the detailed description
the current study was carried on 24 patients suffering from Oro-Antral Communications. All patients were divided into 4 equal groups.
- Conditions
- Healthy Volunteers Only
- Being tested
- Buccal Pad of Fat, A-PRF, fibrin glue, oxidized cellulose
- Keywords
- Benacel;, bone regeneration;, platelet rich growth factor;, Oro-Antral Communication, buccal pad of fat, fibrin glue
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal Pad of FatProcedure or surgery
surgical procedure
A-PRFProcedure or surgery
blood sample
fibrin glueProcedure or surgery
procedure
oxidized celluloseProcedure or surgery
procedure
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | patients were treated using Buccal Pad of Fat for management of OAC. Receives: Procedure: Buccal Pad of Fat |
| Group II | Active comparator | patients were treated using A-PRF technique for management of OAC. Receives: Procedure: A-PRF |
| Group III | Active comparator | patients were treated with Fibrin Glue for management of OAC. Receives: Procedure: fibrin glue |
| Group IV | Active comparator | oxidized regenerated cellulose plug have been used for management of OAC. Receives: Procedure: oxidized cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
o Recurrence
presence or absence
Measured: 6 months
Secondary outcomes (1)
pain, visual analog scale
0 no pain, 10 severe pain
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2019
- Primary completion1 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers OnlyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermine Ramadan Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220877
- Sponsor's protocol ID
- RECO6U/19-2020
- Acronym
- OAC
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mahmoud NR. Buccal pad of fat, advanced platelet-rich fibrin, fibrin glue, and oxidized cellulose plug in the management of oroantral communication: A comparative clinical study. J Stomatol Oral Maxillofac Surg. 2025 Oct;126(5S):102376. doi: 10.1016/j.jormas.2025.102376. Epub 2025 Apr 15.
PubMed 40246197
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Buccal Pad of Fat, Advanced Platelet Rich Fibrin, Fibrin Glue and Oxidized Cellulose Plug in Management of Oro-Antral Communication, Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT06220877
- Acronym / sponsor ID
- OAC / RECO6U/19-2020
- Conditions
- Healthy Volunteers Only
- Keywords
- Benacel;, bone regeneration;, platelet rich growth factor;, Oro-Antral Communication, buccal pad of fat, fibrin glue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 24 Jan 2024 (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.
Evaluation of the efficacy of different treatment protocols in the management of Oro-Antral Communications.
Detailed description
the current study was carried on 24 patients suffering from Oro-Antral Communications. All patients were divided into 4 equal groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: Buccal Pad of Fatpatients were treated using Buccal Pad of Fat for management of OAC. |
| Group II | Active comparator | Procedure: A-PRFpatients were treated using A-PRF technique for management of OAC. |
| Group III | Active comparator | Procedure: fibrin gluepatients were treated with Fibrin Glue for management of OAC. |
| Group IV | Active comparator | Procedure: oxidized celluloseoxidized regenerated cellulose plug have been used for management of OAC. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- patients suffering from oroantral communications
- patients suffering from oroantral fistula.
- The Diameter of the opening ranged from 4-9 mm,
- communication resulted from recent extraction,
- foreign body; or
Key exclusion criteria (6 listed)
- Patients suffering from any systemic diseases were excluded from the study.
- diabetes,
- autoimmune diseases,
- cancers,
- nephropathy,
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 |
|---|---|---|
| Buccal Pad of Fatsurgical procedure | Procedure or surgery | Group I |
| A-PRFblood sample | Procedure or surgery | Group II |
| fibrin glueprocedure | Procedure or surgery | Group III |
| oxidized celluloseprocedure | Procedure or surgery | Group IV |
Primary outcome
o Recurrence
Time frame: 6 months
presence or absence
1 secondary outcome
pain, visual analog scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 40246197Mahmoud NR. Buccal pad of fat, advanced platelet-rich fibrin, fibrin glue, and oxidized cellulose plug in the management of oroantral communication: A comparative clinical study. J Stomatol Oral Maxillofac Surg. 2025 Oct;126(5S):102376. doi: 10.1016/j.jormas.2025.102376. Epub 2025 Apr 15.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal Pad of Fat, A-PRF and fibrin glue in people with Healthy Volunteers Only, run by October 6 University 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
o Recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06220877, which also lists 1 linked publication.
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 24 Jan 2024.