This planning grant will serve to plan a randomized control trial among five research centers to test whether adolescent maxillary protraction can be a non-surgical alternative to orthognathic surgery as a treatment for a skeletal underbite in the cleft lip and palate patient population. We will compare cleft lip and palate patients treated with maxillary protraction at ages 12-14 with cleft lip and palate patients who undergo orthognathic surgery at a later age, usually ages 17-19, when jaw growth as determined by radiographic and clinical assessment, has ceased. The patients who enter the maxillary protraction protocol will be treated earlier than the surgery patients. This planning grant will test the feasibility of a randomized trial and provide the basis for a long-term study which would follow the protracted patients through their late teenage years when they would traditionally be treated with surgery in order to study the effects of late growth and treatment relapse on maxillary protraction during adolescence. PROJECT NARRATIVE: This research is designed to provide a sound evidence base for surgical and orthodontic care of children with cleft lip and palate, the most common facial birth defect. This grant will serve to plan a clinical trial among five research centers to test whether an orthopedic, non-surgical treatment can be an alternative to surgery for these patients.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21DE019164-01
Application #
7510579
Study Section
Special Emphasis Panel (ZDE1-RW (19))
Program Officer
Atkinson, Jane C
Project Start
2009-09-25
Project End
2011-08-31
Budget Start
2009-09-25
Budget End
2010-08-31
Support Year
1
Fiscal Year
2009
Total Cost
$243,250
Indirect Cost
Name
University of Southern California
Department
Dentistry
Type
Schools of Dentistry
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
Guo, J; Wang, Q; Wai, D et al. (2015) Visible red and infrared light alters gene expression in human marrow stromal fibroblast cells. Orthod Craniofac Res 18 Suppl 1:50-61
McIlvaine, Elizabeth; Borzabadi-Farahani, Ali; Lane, Christianne J et al. (2014) Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion. Int J Pediatr Otorhinolaryngol 78:725-30
Chung, Eun Hee; Borzabadi-Farahani, Ali; Yen, Stephen L-K (2013) Clinicians and laypeople assessment of facial attractiveness in patients with cleft lip and palate treated with LeFort I surgery or late maxillary protraction. Int J Pediatr Otorhinolaryngol 77:1446-50
Yen, Stephen L-K (2011) Protocols for Late Maxillary Protraction in Cleft Lip and Palate Patients at Childrens Hospital Los Angeles. Semin Orthod 17:138-148