Relationship Between Critical-size of the Cleft Alveolus and Success of Secondary Bone Grafting
Rishma Shah
Primary Investigator
Brief description of study
What is the purpose of this study?
This study will investigate the relationship between alveolar cleft defect size and bone grafting success. Secondary factors to success will also be investigated.
Detailed description of study
What will happen during the study?
There are two methods of data collection in this study with two sets of research subjects.
1) The retrospective portion of this study will include the review of charts and facial photographs of children only. These children will have completed alveolar bone grafting for cleft lip/palate (CL/P) and a waiver of consent/authorization will be requested for the use of their data.
2) The prospective portion of this study will include children who will be undergoing alveolar bone grafting. Data will be collected from their chart as in the retrospective group, but children and their parent/legal guardian will complete quality of life questionnaires before- and at the 3-month review after alveolar bone grafting.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cleft lip, Cleft palate, CL/P
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Age: 5 years - 13 years
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Gender: All
Inclusion criteria:
• Unilateral cleft lip and/or palate
• Pre-graft CBCT (if ortho expansion, must be taken after completion)
• Undergoing or completed alveolar bone grafting with the use of any type of bone graft material
• Provide consent via that described above
• Age 5 to 13 at the time of entry into the study
Exclusion criteria:
• Significant medical history that may influence bone healing
• Simultaneous nasal reconstruction
