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

NCT ID: NCT06294522

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2024-02-16

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

Conditions

Alveolar Cleft

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

reconstruction of alveolar cleft

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

patients had alveolar cleft adequate and healthy soft tissue

-

Exclusion Criteria

• age less than 9 very wide cleft scared soft tissue

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

mona samy sheta

lecturer of oral and maxillofacial surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mona s sheta

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Faculty of Dentistry, Tanta University

Tanta, , Egypt

Countries

Egypt

Other Identifiers

1984

Identifier Type: -

Identifier Source: org_study_id