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

NCT06294522 | Completed

• 1 other identifier: 1984
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alveolar Cleft

Keywords

alveolar cleft; nasal floor support; autogenous bone graft

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

reconstruction of alveolar cleft

EXPERIMENTAL

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

Interventions

reconstruction of alveolar cleft 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

reconstruction of alveolar cleft

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients had alveolar cleft adequate and healthy soft tissue

You may not qualify if:

• age less than 9 very wide cleft scared soft tissue

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

Location

Study Officials

• mona s sheta

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral and maxillofacial surgery department

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: July 20, 2023
• Primary Completion: January 6, 2024
• Study Completion: February 16, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

EG (1)