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Completed

NCT Number: NCT05002920

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

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.

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Key information

Conditions

Cleft Lip and Palate Bone Graft; Complications Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alveolar bone grafting

Procedure

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

Primary outcomes

  1. bone mineral density

    Time frame: post-ABG six months

    measuring the bone density from cone beam CT

  2. bone mineral density

    Time frame: post-ABG two years

    measuring the bone density from cone beam CT

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2021
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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