Radiographic Evaluation of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft

3D Radiographic Evaluation of the Long Terms Results of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft: Comparison of Early Versus Late Secondary Grafting SABG : Secondary Alveolar Bone Grafting

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04845308

Acronym

SABG

Enrollment

Registered

2021-04-14

Start date

2021-04-01

Completion date

2021-07-30

Last updated

2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Cleft

Keywords

Secondary alveolar bone grafting, 3D score, Navigation system, 3D-reconstruction, Bone loss

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Kamperos's score	Day 1	Kamperos's score (a post-operative tri-dimensional scanographic score) This score includes 3 items measured on the post-operative CT: graft bone thickness (0 to 2), bone graft height (0 to 4) and nasal floor height (0 to 4). A total score of 0 to 8 is considered a failure and 9 to 10 a success

Secondary

Measure	Time frame	Description
Bergland's score	day 1	Bergland's score (a post-operative two-dimensional radiographic score) Post-operative two-dimensional radiographic score : Use of the Bergland score (reference score). This score evaluates the height of the inter-dental bone septum up to the cemento - enamel junction (1 to 4).
Post-operative average bone density of the grafted area in axial slice	day 1	Post-operative average bone density of the grafted area : in axial slice using radiological image processing software (Myrian®) to segment regions of interest.
Nasal floor level of the grafted side compared to the non grafted side using 3D visualization by volume rendering	day 1	Nasal floor level by analyzing the level of the piriform orifice in relation to the grafted area using 3D visualization by volume rendering: percentage of the height between the piriform orifice to the alveolar crest of the grafted side relative to the controlateral side (the healthy side considered as the reference 100% side).

Countries

France

Outcome results