Alveolar Bone Graft Cortical Nasal Floor

Alveolar Cleft Operated on an Alveolar Bone Graft Clinical Trial

Official title:

Comparison Between Alveolar Bone Graft With Only Cancellous Bone, and Alveolar Bone Graft With Cancellous Bone Combined With Nasal Cavity Floor's Reconstruction Using a Cortical Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883373
• Other study ID #: RECHMPL19_0136
• Status: Completed
• Start date: June 1, 1999
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: March 1, 2019
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 20 Years

Eligibility

Inclusion criteria:

• Patients with a clef lip and palate or alveolar cleft

• Grafted in the Montpellier pediatric surgery unit from june 1999 to mai 2016

• Followed during 6 months of post operative follow up

Exclusion criteria:

• No post operative follow up

• other alveolar bone graft in the past medical history

Related Conditions & MeSH terms

• Alveolar Cleft Operated on an Alveolar Bone Graft

Intervention

Procedure:
• alveolar bone graft with cancellous bone and a cortical block
alveolar bone graft with cancellous bone only
• alveolar bone graft with cancellous bone only
alveolar bone graft with cancellous bone only

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication events	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	6 months