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CompletedNCT05002920Updated Aug 12, 2021

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

An observational study in Cleft Lip and Palate and Bone Graft; Complications, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 8 Years to 10 Years. Per ClinicalTrials.gov, last updated 2021-08-12.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
39
Ages
8 Years to 10 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cleft Lip and Palate
  • Bone Graft; Complications

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Keywords

  • alveolar bone grafting
  • body mass index
  • bone mineral density
  • cone beam computed tomography
03

In context

Cleft Lip

162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.

This study's enrollment of 39 is below the median of 100 across 45 observational studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

the patients with unilateral and bilateral cleft lip and palate received alveolar bone graft at their 9 year of age.

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

Exclusion Criteria:

  • syndromic cleft
  • patients with failed grafted tissue
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
39 participants (actual)
Patient registry
No

Groups and cohorts

  • cleft patients received 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.

    Procedure: alveolar bone grafting

Interventions

  • Procedurealveolar bone grafting

    the surgery of alveolar bone graft for alveolar defect in cleft patients

06

What researchers measure

Primary outcomes

  1. bone mineral density

    measuring the bone density from cone beam CT

    Time frame: post-ABG six months

  2. bone mineral density

    measuring the bone density from cone beam CT

    Time frame: post-ABG two years

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, Taiwan
08

References and documents

Individual participant data

Plan to share: No — no plan shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05002920
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Pangyunchou (Assistant Professor, Chang Gung Memorial Hospital) — Principal investigator
First posted
Aug 12, 2021
Start date
Jan 25, 2021
Primary completion
Jun 2, 2021
Completion
Jul 4, 2021
Last update
Aug 12, 2021

Study contacts

Pangyun Chou
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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