Alveolar Bone Graft Cortical Nasal Floor

NCT ID: NCT03883373

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-06-01

Study Completion Date

2019-03-01

Brief Summary

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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

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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

Conditions

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Alveolar Cleft Operated on an Alveolar Bone Graft

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cortical group

Group of patient who had an alveolar bone graft with cancellous bone and a cortical block

alveolar bone graft with cancellous bone and a cortical block

Intervention Type PROCEDURE

alveolar bone graft with cancellous bone only

Cancellous group

Group of patient who had an alveolar bone graft with cancellous bone only

alveolar bone graft with cancellous bone only

Intervention Type PROCEDURE

alveolar bone graft with cancellous bone only

Interventions

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alveolar bone graft with cancellous bone and a cortical block

alveolar bone graft with cancellous bone only

Intervention Type PROCEDURE

alveolar bone graft with cancellous bone only

alveolar bone graft with cancellous bone only

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume CAPTIER, MD.PhD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL19_0136

Identifier Type: -

Identifier Source: org_study_id

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