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

Alveolar Cleft Clinical Trial

— SABG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845308
• Other study ID #: RECHMPL21_0190
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 30, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Cleft
• Neoplasm Metastasis

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kamperos's score	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	Day 1
Secondary	Bergland's score	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).	day 1
Secondary	Post-operative average bone density of the grafted area in axial slice	Post-operative average bone density of the grafted area : in axial slice using radiological image processing software (Myrian®) to segment regions of interest.	day 1
Secondary	Nasal floor level of the grafted side compared to the non grafted side using 3D visualization by volume rendering	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).	day 1