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Alveolar Bone Graft Cortical Nasal Floor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883373
Recruitment Status : Completed
First Posted : March 20, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
Alveolar Cleft Operated on an Alveolar Bone Graft Procedure: alveolar bone graft with cancellous bone and a cortical block Procedure: alveolar bone graft with cancellous bone only

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

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Study Type : Observational
Actual Enrollment : 302 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : June 1, 1999
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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




Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883373


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Guillaume CAPTIER, MD.PhD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03883373    
Other Study ID Numbers: RECHMPL19_0136
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
alveolar graft
cancellous bone
cortical block
nasal floor