Oroantral FistulaNCT07782151
Comparison of Pain Between Buccal Fat Pad and Buccal Advancement Flap
A study testing Buccal fat pad flap and Buccal advancement flap in people with Oroantral Fistula, run by Asma Noureen at 1 site in Pakistan.
Trial summary
This randomized controlled trial compares postoperative pain following surgical closure using a buccal fat pad flap versus a buccal advancement flap. The study aims to determine whether there is a difference in postoperative pain between the two surgical techniques in patients undergoing treatment for oroantral… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Oroantral Fistula
- What is being tested?
- Buccal fat pad flap and Buccal advancement flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Jun 2025to 8 Oct 2025
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with clinically diagnosed oroantral fistula (OAF).
- Age 30 to 60 years.
- Both male and female patients who are Pakistani nationals.
- Patients willing to continue with the study.
Who cannot join
- Patients with diabetes mellitus.
- Patients with oral cancer.
- Patients who have received head and neck radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF PAIN BETWEEN BUCCAL FAT PAD AND BUCCAL ADVANCEMENT Flap: A Randomized CONTROLLED TRIAL
This randomized controlled trial compares postoperative pain following surgical closure using a buccal fat pad flap versus a buccal advancement flap. The study aims to determine whether there is a difference in postoperative pain between the two surgical techniques in patients undergoing treatment for oroantral fistula. Pain will be assessed after surgery using the study's predefined pain assessment method.
- Conditions
- Oroantral Fistula
- Being tested
- Buccal fat pad flap, Buccal advancement flap
- Keywords
- Oroantral fistula, Buccal Fat pad, Buccal advancement flap, Oroantral fistula closure, Postoperative pain
- Medical subject headings
- Oroantral Fistula, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal fat pad flapProcedure or surgery
Surgical closure using a buccal fat pad flap. Postoperative pain will be assessed following the procedure.
Buccal advancement flapProcedure or surgery
Surgical closure using a buccal advancement flap. Postoperative pain will be assessed following the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Buccal fat pad | Experimental | Participants assigned to this arm will undergo surgical closure using a buccal fat pad flap. Postoperative pain will be assessed and compared with the buccal advancement flap group. Receives: Procedure: Buccal fat pad flap |
| Buccal advancement flap | Active comparator | Participants assigned to this arm will undergo surgical closure using a buccal advancement flap. Postoperative pain will be assessed and compared with the buccal fat pad group. Receives: Procedure: Buccal advancement flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measured by Visual Analogue Scale (VAS)
Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 24 hours and 7 days after surgery. The VAS ranges from 0 to 100 mm, where 0 mm represents no pain and 100 mm represents the worst pain imaginable. Higher scores indicate greater pain and therefore a worse outcome. Pain scores will be compared between patients treated with buccal fat pad flap and buccal advancement flap.
Measured: 24 hours and 7 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start9 Jun 2025
- Primary completion8 Oct 2025
- Study completion8 Oct 2025
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asma Noureen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asma Noureen, Sharif Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782151
- Sponsor's protocol ID
- SMDC/SMRC/246-22
- Other IDs
- SMDC/SMRC/246-22
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF PAIN BETWEEN BUCCAL FAT PAD AND BUCCAL ADVANCEMENT Flap: A Randomized CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07782151
- Acronym / sponsor ID
- SMDC/SMRC/246-22
- Conditions
- Oroantral Fistula
- Keywords
- Oroantral fistula, Buccal Fat pad, Buccal advancement flap, Oroantral fistula closure, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asma NoureenUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 24 Aug 2026 (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.
This randomized controlled trial compares postoperative pain following surgical closure using a buccal fat pad flap versus a buccal advancement flap. The study aims to determine whether there is a difference in postoperative pain between the two surgical techniques in patients undergoing treatment for oroantral fistula. Pain will be assessed after surgery using the study's predefined pain assessment method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal fat pad | Experimental | Procedure: Buccal fat pad flapParticipants assigned to this arm will undergo surgical closure using a buccal fat pad flap. Postoperative pain will be assessed and compared with the buccal advancement flap group. |
| Buccal advancement flap | Active comparator | Procedure: Buccal advancement flapParticipants assigned to this arm will undergo surgical closure using a buccal advancement flap. Postoperative pain will be assessed and compared with the buccal fat pad group. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with clinically diagnosed oroantral fistula (OAF).
- Age 30 to 60 years.
- Both male and female patients who are Pakistani nationals.
- Patients willing to continue with the study.
Key exclusion criteria (3 listed)
- Patients with diabetes mellitus.
- Patients with oral cancer.
- Patients who have received head and neck radiotherapy.
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 fat pad flapSurgical closure using a buccal fat pad flap. Postoperative pain will be assessed following the procedure. | Procedure or surgery | Buccal fat pad |
| Buccal advancement flapSurgical closure using a buccal advancement flap. Postoperative pain will be assessed following the procedure. | Procedure or surgery | Buccal advancement flap |
Primary outcome
Postoperative pain measured by Visual Analogue Scale (VAS)
Time frame: 24 hours and 7 days post-operation
Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 24 hours and 7 days after surgery. The VAS ranges from 0 to 100 mm, where 0 mm represents no pain and 100 mm represents the worst pain imaginable. Higher scores indicate greater pain and therefore a worse outcome. Pain scores will be compared between patients treated with buccal fat pad flap and buccal advancement flap.
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 Aug 2026.
- Individual participant dataSharing planned: No
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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 fat pad flap and Buccal advancement flap in people with Oroantral Fistula, run by Asma Noureen at 1 site in Pakistan.
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 4 inclusion and 3 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 Aug 2026. 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 Pakistan. 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?
Postoperative pain measured by Visual Analogue Scale (VAS) (time frame: 24 hours and 7 days post-operation). 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 24 Aug 2026.