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

NCT05002920 | Completed DMC

• 1 other identifier: 201702342A3C501
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cleft Lip and Palate; Bone Graft; Complications

Keywords

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

Outcome Measures

Primary Outcomes (2)

• bone mineral density

  measuring the bone density from cone beam CT

  post-ABG six months

• bone mineral density

  measuring the bone density from cone beam CT

  post-ABG two years

Study Arms (1)

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

alveolar bone grafting PROCEDURE

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

cleft patients received alveolar bone grafting

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• syndromic cleft
• patients with 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

  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: Assistant Professor

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 12, 2021
• Study Start: January 25, 2021
• Primary Completion: June 2, 2021
• Study Completion: July 4, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)