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Clinical Trials/NCT04987190
NCT04987190CompletedNot Applicable

Progressive Comparison of Density Assessment of Alveolar Bone Graft in Patients With Unilateral and Bilateral Cleft

Chang Gung Memorial Hospital1 site in 1 country40 target enrollmentStarted: January 25, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
mean calibrated bone mineral density (BMD/pogonion density, BMDc)

Study Overview

Brief Summary

The patients with unilateral and bilateral cleft lip and palate received alveolar bone graft surgery. Two time points of cone beam CT were taken for all the patients: post-operative 6 months, and post-operative 2 years. All the CT images were reviewed for the analysis of grafted bone density.

Detailed Description

Patient Information and Data Collection Patients who had nonsyndromic unilateral or bilateral cleft lip and alveolus with or without cleft palate and received ABG at our center between 2016 and 2018 were enrolled. All patients underwent at least 2 CBCT scans after operation. Postoperative image acquisition was performed at two time points, namely 6 months (T1) and 2 years (T2) after ABG. The ABG procedures for all patients were performed by the same senior surgeon per the protocol of our center, which comprises an iliac cancellous bone graft and the sealing of the Scarpa fascia to the defect before the bone graft is packed.2,12 Patient who had syndromic cleft alveolus, who underwent two-stage ABG (performed for bilateral cases), or who exhibited failed grafted tissue were excluded. In total, 40 patients were enrolled in the present study. The demographic and clinical variables for ABG were retrospectively collected through a review of medical charts. All CBCT images were obtained using an i-CAT CBCT scanner (Imaging Sciences International, Hatfield, PA, USA); the parameters for the images are as follows: 120 kVp, voxel size of 0.4 × 0.4 × 0.4 mm3, 40-s scan time, and 22 × 16-cm field of view.

BMD Measurement The Picture Archiving and Communication System (PACS) was applied for image analysis. In addition, areas of interest were checked in the axial view slice by slice to locate the grafted tissue. Three methods (A, B, and C), which differed by the size of the selected area, were designed to measure Hounsfield units (HU). For all methods, we first identified the most superior and inferior planes transecting the grafted tissue. Subsequently, the middle plane of the grafted tissue was identified. For the selected plane, the distance between two teeth had to be larger than 2.5 mm in diameter; this was required for all three methods. On each plane, the selected circular area is defined as being located at the midpoint of the line between the centers of the two adjacent teeth. The HU of the selected area could be obtained using PACS.

For Method A, the circular zone located 1 mm from the adjacent teeth was selected. For Method B, the largest circular zone that exactly transected the two adjacent teeth or was tangent to the surrounding cortical bone was selected. For Method C, a circle was drawn with a diameter of 2 mm. Furthermore, an area of 2 × 0.5 mm2 in the pogonion was selected to obtain its HU at T1 and T2; this was the reference for calibration (Figure, Supplemental Digital Content 1). HU was the reference for BMD13 and represented the average density of the three planes. Calibrated BMD (BMDc, %) was defined using the following formula:

〖BMD〗c (%)=〖HU〗(selected zone)/〖HU〗_pogonion ×100.

Density enhancement rate (%) was calculated using the following formula:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
8 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who had nonsyndromic unilateral or bilateral cleft lip and alveolus with or without cleft palate
  • Patients received alveolar bone graft at their 9 years of age
  • Patients received twice CBCT after the surgery

Exclusion Criteria

  • Patient had syndromic cleft alveolus
  • Patient underwent two-stage ABG (performed for bilateral cases)
  • Patient exhibited failed grafted tissue

Outcomes

Primary Outcomes

mean calibrated bone mineral density (BMD/pogonion density, BMDc)

Time Frame: 2nd BMD at post-operative 2 years

BMD presented from CBCT

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chang Gung Memorial Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pangyunchou

Craniofacial Research Center

Chang Gung Memorial Hospital

Study Sites (1)

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