Alveolar Bone Graft Cortical Nasal Floor

August 8, 2019 updated by: University Hospital, Montpellier

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are suffering from clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periostoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cortical group
Group of patient who had an alveolar bone graft with cancellous bone and a cortical block
Procedure: alveolar bone graft with cancellous bone and a cortical block
alveolar bone graft with cancellous bone only
Cancellous group
Group of patient who had an alveolar bone graft with cancellous bone only
Procedure: alveolar bone graft with cancellous bone only
alveolar bone graft with cancellous bone only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication events
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 1999

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (ACTUAL)

March 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL19_0136

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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