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

Completed

• Conditions: Alveolar Cleft

• Registration Number: NCT04845308
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-04-10
• Study First Posted: 2021-04-14
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France