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NCT05002920 Clinical Trial

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

Cleft Lip and Palate Clinical Trial

Official title:
Correlation Between Body Mass Index and Progressive Bone Mineral Density in Cleft Patients After Secondary Alveolar Bone Grafting

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05002920
Other study ID # 201702342A3C501
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 25, 2021
Est. completion date July 4, 2021

Study information
Verified date August 2021
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date July 4, 2021
Est. primary completion date June 2, 2021
Accepts healthy volunteers No
Gender All
Age group 8 Years to 10 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• alveolar bone grafting
the surgery of alveolar bone graft for alveolar defect in cleft patients

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary bone mineral density measuring the bone density from cone beam CT post-ABG six months
Primary bone mineral density measuring the bone density from cone beam CT post-ABG two years
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