Cleft lip and palate is the most commons facial birth defect. One of the most difficult problems associated with cleft treatment is the Class III malocclusion or skeletal underbite. LeFort 1 maxillary advancement is the current standard of care, and is used to correct the underbite after pubertal growth is complete but it is the most difficult and most expensive surgery the patient will undergo. This grant proposes to compare the current standard of care to a non-surgical approach, maxillary protraction in a non-randomized prospective cohort study. The two cohorts represent treatments that are given at two different ages for correcting the Cl III malocclusion in adolescents with cleft lip and palate. The early treatment, maxillary protraction, starts at age 13, is given at this time because the maxillary sutures have not fused yet and are amenable to manipulation. The late treatment, given at age 17, is orthognathic surgery when the maxillary sutures have fused and when adolescent growth is complete. This project addresses the question: Can protraction correct the malocclusion and eliminate or reduce the need for surgery in the late treatment ages? We originally set out to develop a randomized trial, and first studied the willingness of the patientsto randomize their treatment between surgery and protraction in 287 patients. This study showed that randomization of treatment involving facial surgery will not be accepted by teenage patients. This grant will support a two- center cohort study that compares surgery and protraction outcomes using records and data collected before and after treatment. It is the first multicenter trial to compare the effectiveness of non-surgical treatment against the current surgical standard of care and will provide evidence for making clinical decisions in the future regarding clinical and cost effectiveness of these treatments. Potential confounders will be measured and assessed using analysis of covariance. The public health benefits of the study are 1) to provide non-surgical and non-invasive alternatives to treatment for the skeletal underbite without taking away surgical options and 2) to reduce the cost of care associated with cleft lip and palate.
In response to RFA-DE-12-006, the proposed study compares orthognathic surgery, the current standard of care, to a non-surgical approach, maxillary protraction, for correcting a skeletal underbite that is often found in patients with clet lip and palate. The economic impact is a major reduction in the cost of care. Late maxillary protraction offers the patient an earlier correction without the morbidity of surgery, and does not take away surgical options in uncooperative patients.
|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|