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Radiographic Evaluation of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft (SABG)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Alveolar Cleft

Study type

Observational

Funder types

Other

Identifiers

NCT04845308
RECHMPL21_0190

Details and patient eligibility

About

Study about the comparison of post-operative results of secondary alveolar grafts according to two age groups: early secondary (4 to 7 years) versus late secondary (8 to 11 years) using a recently proposed score based on post-operative 3D CT analysis.

Comparison of the initial results of the graft in the two groups, with a reference 2D score and evaluation of the concordance between the results found with this score and those of the 3D score.

Finally, comparison of graft bone densities and nasal floor level (using 3D visualization) on post-operative TDMs in the 2 groups.

The aim of this study is to determine the optimal age for grafting using three-dimensional CT assessment.

Enrollment

49 patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients operated with an alveolar bone grafting for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021 and having had 3D imageries defined as:
  • Group 1:

    o Patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3D imaging (CT, CBCT or scan) performed between the ages of 8 to 11 years.

  • Group 2:

    • Patients operated with a late secondary alveolar graft between the ages of 8 to 11 years with a 3D imaging (CT, CBCT or scan) performed at least 1 year after the operation.

Exclusion criteria

  • Patients operated with an alveolar bone grafting before 4 years or after 11 years
  • Patients without post-operative CT

Trial design

49 participants in 2 patient groups

Group 1
Description:
Patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3D imaging (CT, CBCT or scan) performed between the ages of 8 to 11 years.
Group 2
Description:
Patients operated with a late secondary alveolar graft between the ages of 8 to 11 years with a 3D imaging (CT, CBCT or scan) performed at least 1 year after the operation.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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