Reconstruction of Nasal Floor for Three-dimensional Repair of Alveolar Cleft

Not Applicable

Completed

• Conditions: Alveolar Cleft
• Interventions: Procedure: reconstruction of alveolar cleft

• Registration Number: NCT06294522
• Lead Sponsor: Tanta University

Brief Summary

reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap

Detailed Description

gingival mucoperiosteal flaps are designed along the cleft margins and elevated medial and lateral mucoperiosteal flaps are generated from the cleft and the gingival sulcus of the teeth. To obtain adequate mobility of the posterior flap, the flap must be extended to the first or the second molar and back-cut up to the buccal sulcus while taking care not to injure the alveolar bone covering the roots of the teeth. These flaps are raised up to and around the piriform aperture, and then are separated from the nasal mucosa the palatal mucoperiosteal flaps along the cleft margins are then elevated from the palate. After complete exposure of all the bony clefts, the nasal lining of the nostril floor is approximated and sutured, and the palatal flaps are then turned back and sutured to make a soft-tissue pocket. Grafting of the defect is accomplished with cortical bone only from the chin the cortical shelf is prepared to be two layers perpendicular to each other the first one is parallel to the nasal floor and second one is continuous with buccal cortex of alveolar ridge then cancellous bone will be packed under these shelves and be compressed into the cleft defect to maximize the number of osteo-competent cells and the osteoid material per unit graft volume. When packing bone particles, it is better to create the maxilla and alveolar ridges and elevate the depressed nostril by appropriately supporting the nasal base and aligning the symmetry. The rest can then be covered with gingival mucoperiosteal flaps through tension-free transposition

Study Timeline

• Study Start: 2023-07-20
• Primary Completion: 2024-01-06
• Study Completion: 2024-02-16
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Status Verified: 2024-03
• Study First Posted: 2024-03-05
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

patients had alveolar cleft adequate and healthy soft tissue

Exclusion Criteria

• age less than 9 very wide cleft scared soft tissue

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
reconstruction of alveolar cleft	reconstruction of alveolar cleft	gingival mucoperiosteal flaps are designed along the cleft margins and elevated. These flaps are raised up and then are separated from the nasal mucosa the palatal mucoperiosteal flaps along the cleft margins are then elevated from the palate. After complete exposure of all the bony clefts, the nasal lining of the nostril floor is approximated and sutured, and the palatal flaps are then turned back and sutured to make a soft-tissue pocket. Grafting of the defect is accomplished with cortical bone only from the chin the cortical shelf is prepared to be two layers perpendicular to each other the first one is parallel to the nasal floor and second one is continuous with buccal cortex of alveolar ridge then cancellous bone will be packed under these shelves and be compressed into the cleft defects.

Primary Outcome Measures

Name	Time	Method
recurrence of oronasal fistula	one month	using valsalva test
volume of alveolar cleft after reconstruction	immediate and after 6 months	using cone beam ct (cbct) to measure volumetric changes
density of bone	Six months	using cbct with housenfield units D1 (\>1250), D2(850-1250),D3(350-850),D4(150-350)

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, Egypt