Cleft PalateNCT07840911
Furlow With Buccinator and Fistula Formation
A study testing furlow with buccinator and two flap palatoplasty in people with Cleft Palate, run by Fayoum University.
Trial summary
Furlow with buccal myomucosal flap (group 1) Local anesthesia with a vasoconstrictor will be injected at the beginning of the surgery after Z- flap outline marking. On the left side, myomucosal posteriorly based flap will be incised containing the levator palateni muscle with a 60◦ angle and elevated. Read more about this study
- Who is it for?
- Ages 9 to 12 months
- Conditions the study is for
- Cleft Palate
- What is being tested?
- furlow with buccinator and two flap palatoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2026to 30 Sep 2027
- 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 9 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 9-12 months old childreen with complete cleft lip and palate, nonsyndromic.
- lip and palate repair performed by one craniofacial surgeon
Who cannot join
- Patients with syndromic cleft lip.
- Redu cases
- Bilateral cleft lip
- Associated Cardiac anomalies.
- Any systemic condition
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: • Fistula Formation in Patients With Cleft Palate Following Primary Furlow Palatoplasty With Buccal Myomucosal Flap Versus Two Flap Palatoplasty
Furlow with buccal myomucosal flap (group 1) Local anesthesia with a vasoconstrictor will be injected at the beginning of the surgery after Z- flap outline marking. On the left side, myomucosal posteriorly based flap will be incised containing the levator palateni muscle with a 60◦ angle and elevated. Another small anteriorly-based nasal mucosa flap will be created. On the opposite side, oral mucosal anteriorly based flap with a 90◦ angle will be incised and elevated. Palatal muscle will be stripped and posteriorly based myomucosal flap was created containing palatal muscle and nasal mucosa. Nasal mucosa will be sutured followed by oral mucosa with minimal palatal muscle overlapping. The oral mucosa defect will be filled with BMMF Two flap palatoplasty surgical steps (group 2) A bilateral tongue like palatal flaps will be incised and elevated from the incisive foramen anteriorly to the hamulus posteriorly medial to the teeth and extended around the cleft area. Palatal muscles will be detached from the palatal shelves and separating it from the nsal mucosa. Nasal layer will be the firstly closed, followed by the muscle and oral mucosal layers. In case of the presence of a bare area of bone, it will be left to heal by secondary intention
- Conditions
- Cleft Palate
- Being tested
- furlow with buccinator, two flap palatoplasty
- Keywords
- cleft palate, fistula
- Medical subject headings
- Cleft Palate, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furlow with buccinatorProcedure or surgery
clefted patients were treated with furlow with buccinator flap
two flap palatoplastyProcedure or surgery
clefted patients were treated with two flap palatoplasty
| Study group | Role | What they receive |
|---|---|---|
| furlow with buccinator | Experimental | Not described Receives: Procedure: furlow with buccinator |
| two flap palatoplasty | Active comparator | Not described Receives: Procedure: two flap palatoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
fistula formation
assessment the fistula formation after cleft palate repair by determination the site of fistula and time at which appear
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840911
- Sponsor's protocol ID
- 44
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 25 Sep 2026
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- • Fistula Formation in Patients With Cleft Palate Following Primary Furlow Palatoplasty With Buccal Myomucosal Flap Versus Two Flap Palatoplasty
- ClinicalTrials.gov ID
- NCT07840911
- Acronym / sponsor ID
- 44
- Conditions
- Cleft Palate
- Keywords
- cleft palate, fistula
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Sep 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.
Furlow with buccal myomucosal flap (group 1) Local anesthesia with a vasoconstrictor will be injected at the beginning of the surgery after Z- flap outline marking. On the left side, myomucosal posteriorly based flap will be incised containing the levator palateni muscle with a 60◦ angle and elevated. Another small anteriorly-based nasal mucosa flap will be created. On the opposite side, oral mucosal anteriorly based flap with a 90◦ angle will be incised and elevated. Palatal muscle will be stripped and posteriorly based myomucosal flap was created containing palatal muscle and nasal mucosa. Nasal mucosa will be sutured followed by oral mucosa with minimal palatal muscle overlapping. The oral mucosa defect will be filled with BMMF Two flap palatoplasty surgical steps (group 2) A bilateral tongue like palatal flaps will be incised and elevated from the incisive foramen anteriorly to the hamulus posteriorly medial to the teeth and extended around the cleft area. Palatal muscles will be detached from the palatal shelves and separating it from the nsal mucosa. Nasal layer will be the firstly closed, followed by the muscle and oral mucosal layers. In case of the presence of a bare area of bone, it will be left to heal by secondary intention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| furlow with buccinator | Experimental | Procedure: furlow with buccinator |
| two flap palatoplasty | Active comparator | Procedure: two flap palatoplasty |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 9-12 months old childreen with complete cleft lip and palate, nonsyndromic.
- lip and palate repair performed by one craniofacial surgeon
Key exclusion criteria (5 listed)
- Patients with syndromic cleft lip.
- Redu cases
- Bilateral cleft lip
- Associated Cardiac anomalies.
- Any systemic condition
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 |
|---|---|---|
| furlow with buccinatorclefted patients were treated with furlow with buccinator flap | Procedure or surgery | furlow with buccinator |
| two flap palatoplastyclefted patients were treated with two flap palatoplasty | Procedure or surgery | two flap palatoplasty |
Primary outcome
fistula formation
Time frame: 6 months postoperative
assessment the fistula formation after cleft palate repair by determination the site of fistula and time at which appear
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 25 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing furlow with buccinator and two flap palatoplasty in people with Cleft Palate, run by Fayoum University.
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 2 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shaimaa Refahee (01227407987, smr11@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fistula formation (time frame: 6 months postoperative). 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 25 Sep 2026.