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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Cleft Lip and Palate
Bone Graft; Complications

Treatments

Procedure: alveolar bone grafting

Study type

Observational

Funder types

Other

Identifiers

NCT05002920
201702342A3C501

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

8 to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

39 participants in 1 patient group

cleft patients received alveolar bone grafting
Description:
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.
Treatment:
Procedure: alveolar bone grafting

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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