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

NCT04845308 | Completed

• 1 other identifier: RECHMPL21_0190
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Cleft

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bergland's score

  day 1

• Post-operative average bone density of the grafted area in axial slice

  day 1

• Nasal floor level of the grafted side compared to the non grafted side using 3D visualization by volume rendering

  day 1

Study Arms (2)

Group 1

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.

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated with an alveolar bone grafting (taken from the anterior iliac crest ) for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021.

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Guillaume CAPTIER, MD.PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 14, 2021
• Study Start: April 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 30, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

FR (1)