Progression of Grafted Bone Density in Cleft Alveolus

NCT04987190 | Completed

• 1 other identifier: 201600968A3
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Palate

Keywords

alveolar bone grafting; alveolar cleft; bone mineral density; density enhancement rate; cone beam computed tomography (CBCT)

Outcome Measures

Primary Outcomes (2)

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

  BMD presented from CBCT

  1st BMD at post-operative 6 months

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

  BMD presented from CBCT

  2nd BMD at post-operative 2 years

Study Arms (1)

all cleft patients divided into unilateral and bilateral groups

One group of cleft patients received the alveolar bone graft surgery

Procedure: alveolar bone graft

Interventions

alveolar bone graft PROCEDURE

alveolar bone graft with Scarpa fascia done when patients were at 9 year of age

all cleft patients divided into unilateral and bilateral groups

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

In total, 40 patients, who had an average age of 9.45 ± 1.61 years when they received ABG, were enrolled.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Cleft Lip

Interventions

Alveolar Bone Grafting

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Surgical Procedures, Operative; Osteotomy; Orthopedic Procedures; Dentistry

Study Officials

• Pangyun Chou, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Craniofacial Research Center

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 3, 2021
• Study Start: January 25, 2021
• Primary Completion: June 2, 2021
• Study Completion: July 4, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

TW (1)