M K Lee1,2, C Lane3, F Azeredo4, M Landsberger1, H Kapadia5, B Sheller5, S L Yen1,2. 1. Division of Dentistry, Children's Hospital Los Angeles, Los Angeles, CA, USA. 2. University of Southern California, Los Angeles, CA, USA. 3. Department of Biostatistics, University of Southern California, Los Angeles, CA, USA. 4. Department of Orthodontics, Pontifical Catholic University of Rio Grande do Sul - PUCRS, Porto Alegre, Brazil. 5. Department of Dentistry, Seattle Children's Hospital, Seattle, WA, USA.
Abstract
OBJECTIVES: A prospective parallel cohort trial was conducted to compare outcomes of patients treated with maxillary protraction vs LeFort 1 maxillary advancement surgery. SETTING AND SAMPLE POPULATION: The primary site for the clinical trial is Children's Hospital Los Angeles; the satellite test site is Seattle Children's Hospital. All patients have isolated cleft lip and palate and a skeletal Class III malocclusion. MATERIAL AND METHODS: A total of 50 patients, ages 11-14, will be recruited for the maxillary protraction cohort. The maxillary surgery cohort consists of 50 patients, ages 16-21, who will undergo LeFort 1 maxillary advancement surgery. Patients with additional medical or cognitive handicaps were excluded from the study. RESULTS: Current recruitment of patients is on track to complete the study within the proposed recruitment period. CONCLUSION: This observational trial is collecting information that will examine dental, skeletal, financial and quality-of-life issues from both research cohorts.
OBJECTIVES: A prospective parallel cohort trial was conducted to compare outcomes of patients treated with maxillary protraction vs LeFort 1 maxillary advancement surgery. SETTING AND SAMPLE POPULATION: The primary site for the clinical trial is Children's Hospital Los Angeles; the satellite test site is Seattle Children's Hospital. All patients have isolated cleft lip and palate and a skeletal Class III malocclusion. MATERIAL AND METHODS: A total of 50 patients, ages 11-14, will be recruited for the maxillary protraction cohort. The maxillary surgery cohort consists of 50 patients, ages 16-21, who will undergo LeFort 1 maxillary advancement surgery. Patients with additional medical or cognitive handicaps were excluded from the study. RESULTS: Current recruitment of patients is on track to complete the study within the proposed recruitment period. CONCLUSION: This observational trial is collecting information that will examine dental, skeletal, financial and quality-of-life issues from both research cohorts.