Oroantral FistulaOAF-DLCNCT07196566
Double-Layer Closure Technique Using Buccal and Palatal Flaps for Oroantral Fistula
A study testing Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft in people with Oroantral Fistula and Double Layer, run by Tanta University at 1 site in Egypt.
Trial summary
A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oroantral Fistula, Double Layer
- What is being tested?
- Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with oroantral fistula
Who cannot join
- patients with repeated oroantral fistula closure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Double-Layer Closure of Oroantral Fistula Using Buccal Split-Thickness and Palatal Subepithelial Connective Tissue Flaps
A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.
Read the detailed description
The proposed double-layer technique achieved high success rates in closing oroantral fistulas with minimal postoperative complications, reduced facial edema, and better preservation of vestibular depth compared to conventional techniques.
A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.
This technique demonstrated reliable, tension-free closure with excellent clinical outcomes, reduced postoperative facial edema, and preserved vestibular depth, supporting its potential as an effective and safe surgical option for managing oroantral fistulas.
The purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
- Conditions
- Oroantral Fistula, Double Layer
- Being tested
- Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft
- Keywords
- oroantral fistula, double layer closure, buccal flap, palatal flap, rotational palatal connective tissue flap
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graftProcedure or surgery
Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.
| Study group | Role | What they receive |
|---|---|---|
| Double-Layer Closure of Oroantral Fistula Using Buccal and palatal Split-Thickness flap | Experimental | A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity. Receives: Procedure: Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of fistula
presence of oroantral fistula or not
Measured: one week -4 weeks
vestibular height
using periodontal prob
Measured: 1-3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start28 Jul 2025
- Primary completion10 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oroantral FistulaStudies 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
- Model description
- All enrolled patients will undergo closure of chronic oroantral fistula using double-layer technique consist of split thickness buccal, palatal flap and rotational palatal underlaying connective tissue. this a single-arm, prospective clinical study.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed sobhie abdelhameed, Tanta University
- Investigators
- mohamed s abdelhameed, Asst lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196566
- Sponsor's protocol ID
- TantaOMS-OAF-DLC2025
- Acronym
- OAF-DLC
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Layer Closure of Oroantral Fistula Using Buccal Split-Thickness and Palatal Subepithelial Connective Tissue Flaps
- ClinicalTrials.gov ID
- NCT07196566
- Acronym / sponsor ID
- OAF-DLC / TantaOMS-OAF-DLC2025
- Conditions
- Oroantral Fistula, Double Layer
- Keywords
- oroantral fistula, double layer closure, buccal flap, palatal flap, rotational palatal connective tissue flap
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Sep 2025 (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.
A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.
Detailed description
The proposed double-layer technique achieved high success rates in closing oroantral fistulas with minimal postoperative complications, reduced facial edema, and better preservation of vestibular depth compared to conventional techniques.
A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.
This technique demonstrated reliable, tension-free closure with excellent clinical outcomes, reduced postoperative facial edema, and preserved vestibular depth, supporting its potential as an effective and safe surgical option for managing oroantral fistulas.
The purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled patients will undergo closure of chronic oroantral fistula using double-layer technique consist of split thickness buccal, palatal flap and rotational palatal underlaying connective tissue. this a single-arm, prospective clinical study.
| Arm | Type | Receives |
|---|---|---|
| Double-Layer Closure of Oroantral Fistula Using Buccal and palatal Split-Thickness flap | Experimental | Procedure: Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graftA prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with oroantral fistula
Key exclusion criteria (1 listed)
- patients with repeated oroantral fistula closure
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 |
|---|---|---|
| Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graftClosure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity. | Procedure or surgery | Double-Layer Closure of Oroantral Fistula Using Buccal and palatal Split-Thickness flap |
Primary outcome
recurrence of fistula
Time frame: one week -4 weeks
presence of oroantral fistula or not
vestibular height
Time frame: 1-3 months postoperatively
using periodontal prob
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Related trials for Oroantral Fistula
Not yet recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Recruiting
A Hinge Flap to Reinforce Buccal Advancement Flap
Oroantral Fistula
Enrolling by invitation
Allogenic Bone Block for Oro-Antral Communication Closure for Subsequent Implant Placement
Tooth Loss
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.
mohamed s abdelhameed, Asst lecturer principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft in people with Oroantral Fistula and Double Layer, run by Tanta 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 29 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
recurrence of fistula (time frame: one week -4 weeks). The study lists 2 primary outcomes in all. 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 29 Sep 2025.