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Not yet recruitingNCT07840911Updated Sep 25, 2026

Furlow With Buccinator and Fistula Formation

An interventional study of furlow with buccinator and two flap palatoplasty in Cleft Palate, sponsored by Fayoum University. Not yet recruiting. Open to participants aged 9 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fayoum University · Not applicable, Interventional, and Treatment

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
9 Months to 12 Months
Sex
All
01

Study 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. 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

02

Conditions studied

  • Cleft Palate

Keywords

  • cleft palate
  • fistula
03

In context

Cleft Palate

123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.

This study's planned enrollment of 20 is below the median of 44 across 77 interventional studies indexed under Cleft Palate.

Browse Cleft Palate studies →

Lead sponsor

Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 9-12 months old childreen with complete cleft lip and palate, nonsyndromic.
  • lip and palate repair performed by one craniofacial surgeon

Exclusion criteria

Exclusion Criteria:

  • Patients with syndromic cleft lip.
  • Redu cases
  • Bilateral cleft lip
  • Associated Cardiac anomalies.
  • Any systemic condition
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    furlow with buccinator

    Procedure: furlow with buccinator

  • Active comparator
    two flap palatoplasty

    Procedure: two flap palatoplasty

Interventions

  • Procedurefurlow with buccinator

    clefted patients were treated with furlow with buccinator flap

  • Proceduretwo flap palatoplasty

    clefted patients were treated with two flap palatoplasty

06

What researchers measure

Primary outcomes

  1. fistula formation

    assessment the fistula formation after cleft palate repair by determination the site of fistula and time at which appear

    Time frame: 6 months postoperative

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 11 months later.

Of 34 non-industry interventional studies with no phase under Cleft Palate, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 11 months is below that.

Counting every sponsor, half of 34 studies reached it within 18 months; a quarter within 12 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 25, 2026
StartEst.
Sep 25, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Sep 30, 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07840911
Lead sponsor
Fayoum University
Responsible party
Shaimaa Mohsen (associate professor, Fayoum University) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 25, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Shaimaa Refahee
Contact
smr11@fayoum.edu.eg
01227407987

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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