Correlation Between Body Mass Index and Progressive Grafted Bone in Cleft Patients

Completed

• Conditions: Cleft Lip and Palate; Bone Graft; Complications
• Interventions: Procedure: alveolar bone grafting

• Registration Number: NCT05002920
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. The study was to analyze the correlation between BMI and post-operative bone mineral density.

Detailed Description

Although childhood obesity is a growing issue, the association between BMI and the progressive bone mineral density (BMD) in grafted tissue after secondar alveolar grafting (ABG) remains little reviewed. This study compared the correlation between BMI and the progressive BMD after ABG procedure. Thirty-nine patients with unilateral or bilateral clefts were enrolled. ABG was performed at mixed-dentition age. Patient were classified into underweight, normal weight, and overweight or obese based on age- and sex-adjusted BMI. BMD was expressed in Hounsfield unit (HU) on cone-beam computed tomography (CBCT), which was obtained at 6 months (T1) and 2 years (T2) postoperatively. Calibrated BMD (HUgrafted tissue/HUpogonion¬, BMDc) was used for further analysis.

Study Timeline

• Study Start: 2021-01-25
• Primary Completion: 2021-06-02
• Study Completion: 2021-07-04
• Study First Submitted: 2021-07-30
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• nonsyndromic unilateral or bilateral cleft lip and alveolus with or without palate patients
• received secondary ABG at Chang Gung Craniofacial Center
• received team managements based on our current treatment protocol for cleft lip and palate

Exclusion Criteria

• syndromic cleft
• patients with failed grafted tissue

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cleft patients received alveolar bone grafting	alveolar bone grafting	alveolar bone grafting was performed when the cleft patients were aged around 9 years old. CBCT was used to analyze the bone mineral density of grafted tissue.

Primary Outcome Measures

Name	Time	Method
bone mineral density	post-ABG two years	measuring the bone density from cone beam CT

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan