Alveolar Bone Graft Cortical Nasal Floor

Completed

• Conditions: Alveolar Cleft Operated on an Alveolar Bone Graft
• Interventions: Procedure: alveolar bone graft with cancellous bone and a cortical block; Procedure: alveolar bone graft with cancellous bone only

• Registration Number: NCT03883373
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest.

The aim of the study is to show if adding a cortical graft to the cancellous cause more complications, which may be source of partial or total graft loss in the 6 month following the observation

Detailed Description

This is an observational, retrospective and monocentric study. To be included, patients had to suffer from a clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periosteoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016. They were divided into two groups : the first with patients who had a cortical and cancellous bone graft and the second with patients who had a cancellous graft only.

Both groups were followed 6 mounts after the operation to look for the occurence of complications which lead to a graft loss. Bilateral cleft are seen as 2 graft events

Study Timeline

• Study Start: 1999-06-01
• Primary Completion: 2016-05-01
• Status Verified: 2019-03
• Study Completion: 2019-03-01
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cortical group	alveolar bone graft with cancellous bone and a cortical block	Group of patient who had an alveolar bone graft with cancellous bone and a cortical block
Cancellous group	alveolar bone graft with cancellous bone only	Group of patient who had an alveolar bone graft with cancellous bone only

Primary Outcome Measures

Name	Time	Method
Complication events	6 months	Analyze retrospective of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for complications during the 6 months of post operative follow up; Analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in Pediatric Emergency department and finally read of the report of the clinical control 1 month after the procedure

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France