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

Alveolar Cleft Clinical Trial

Official title:

Lecturer of Oral and Maxillofacial Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06294522
• Other study ID #: 1984
• Status: Completed
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: February 16, 2024

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 16, 2024
• Est. primary completion date: January 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

patients had alveolar cleft adequate and healthy soft tissue

-

Exclusion Criteria:

• age less than 9 very wide cleft scared soft tissue

Related Conditions & MeSH terms

• Alveolar Cleft

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

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