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

Lecturer of Oral and Maxillofacial Surgery

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

Study Overview

• Status: Completed
• Conditions: Alveolar Cleft
• Intervention / Treatment: Procedure: reconstruction of alveolar cleft

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 3111
    • Faculty of Dentistry, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

patients had alveolar cleft adequate and healthy soft tissue

-

Exclusion Criteria:

• age less than 9 very wide cleft scared soft tissue

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: reconstruction of alveolar cleft; after elevation of mucoperiosteal flap related to cleft side. suturing of nasal floor and palatal tissue. harvesting of autogenous graft and reconstruction of nasal floor and labial plate of cleft then suturing of flap labially without tension

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: mona s sheta, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): January 6, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: alveolar cleft; autogenous bone graft; nasal floor support
• Other Study ID Numbers: 1984

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No