Furlow With Buccinator and Fistula Formation

NCT07840911 | Not Yet Recruiting DMC

• 1 other identifier: 44
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cleft Palate

Keywords

cleft palate; fistula

Outcome Measures

Primary Outcomes (1)

• fistula formation

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

  6 months postoperative

Study Arms (2)

furlow with buccinator

EXPERIMENTAL

Procedure: furlow with buccinator

two flap palatoplasty

ACTIVE COMPARATOR

Procedure: two flap palatoplasty

Interventions

furlow with buccinator PROCEDURE

clefted patients were treated with furlow with buccinator flap

furlow with buccinator

two flap palatoplasty PROCEDURE

clefted patients were treated with two flap palatoplasty

two flap palatoplasty

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Conditions

Cleft Palate; Fistula

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shaimaa Refahee

CONTACT

01227407987; smr11@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 25, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09