Clinical effectiveness of late maxillary protraction in cleft lip and palate: A methods paper

Structured Abstract ObjectivesA prospective parallel cohort trial was conducted to compare outcomes of patients treated with maxillary protraction vs LeFort 1 maxillary advancement surgery. Setting and Sample PopulationThe 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 MethodsA 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. ResultsCurrent recruitment of patients is on track to complete the study within the proposed recruitment period. ConclusionThis observational trial is collecting information that will examine dental, skeletal, financial and quality-of-life issues from both research cohorts.