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

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.