Clinical Trial: Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate

Brief Summary: Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusions or underbites following early cleft repair surgeries. This clinical trial compares the current standard of care for treating the Cl III malocclusion, orthognathic (jaw) surgery after pubertal growth (16-21 years), with an alternative orthopedic approach to protract the maxilla during adolescence (11-14 years). At Children's Hospital Los Angeles(CHLA), early adolescents with cleft lip and palate and Cl III malocclusion are offered an alternative non-surgical approach to correct the malocclusion called "maxillary protraction". Prior to age 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper jaw (maxilla) to be pulled forward (protracted) to correct the underbite. This prospective parallel cohort study will assess the patients undergoing treatment for the Cl III malocclusion by either orthognathic surgery or maxillary protraction at four data collection time points during treatment. The data includes digitized study models, photographs and radiographs, quality of life surveys (SF12, YQOL), parent surveys (ASEBA), treatment cost, periodontal measurements and treatment complications. The study design is a descriptive cohort study that examines the success of treatment (% not requiring a second surgery), the dental and skeletal changes associated with treatment, the stability of treatment and the behavioural/adaptive factors (ASEBA) that contribute to success and lack of success for each treatment. The primary trial will be conducted at Children's Hospital Los Angeles and a pilot study to confirm translation to different settings will be conducted at Seattle Children's Hospital.

Detailed Summary:

Rationale: Cleft lip and palate is the most common facial birth defect. Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusion or underbites for which the current standard of care to treat the Cl III malocclusion is orthognathic (jaw) surgery. Orthognathic surgery is performed late in a teenager's life after pubertal growth is complete, has a long recovery period, has risks for segment loss and nerve injury and is expensive to the insurers. Moreover, the surgical correction can relapse and require a second jaw surgery.

Intervention: The current standard of care for correcting a Cl III malocclusion is orthognathic surgery after pubertal growth is complete. At Children's Hospital, early adolescents (11 - 14 yrs) with cleft lip and palate and Cl III malocclusion are offered an alternative non-surgical approach to correct the malocclusion called "maxillary protraction". At ages 11- 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper jaw (maxilla) to be pulled forward (protracted) in order to correct the underbite.

Purpose: This study will compare the occlusal, photographic, radiographic, periodontal and quality of life data collected at four different timepoints from patients who were treated for the correction of their Cl III malocclusion by either LeFort I maxillary advancement surgery or non-surgical maxillary protraction.

Study Population: The inclusion criteria are patients who are diagnosed with isolated cleft lip and palate with Cl III malocclusion and who, at the time of enrollment, do not have any medical condition which will prevent them from undergoing orthognathic surgery or maxillary protraction procedur
Sponsor: University of Southern California

Current Primary Outcome: Bite correction of digitized models. [ Time Frame: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery. ]

The metric for comparing the difference in bite using study models from patients with cleft lip and palate is the "GOSLON Yardstick" which can rate antero-posterior as well as transverse positions.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cephalometric radiographs [ Time Frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery. ]
    The cephalometric radiographs from the different time points are stored in Dolphin imaging software and digitized for orthodontic and surgical cephalometric analyses. This type of analysis can examine differences between skeletal vs. dental changes between time points.
  • Facial attractive rating of photographs [ Time Frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery. ]
    The pre-treatment and post-treatment facial photographs of all of the patients in the study will be randomly presented for rating using an analog scale for facial attractiveness. The photographs are presented in a secure database file within the hospital to lay and clinician raters for evaluating the photographs. This type of rating survey can provide data on amount and direction of facial change with each treatment.
  • Costs of treatments [ Time Frame: At the end of approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery. ]
    The number of visits and current procedural terminology(CPT) codes for the visits will be used to define cost units. The actual costs for CHLA and SCH will be calculated by assigning the hospital charges for those CPT codes.
  • 12-Item Short Form Health Survey (SF-12) developed by the Rand Corporation [ Time Frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery. ]
    The SF-12 is a short form standardized instrument for medical outcome study.
  • Youth Quality of Life (YQOL) survey designed by the Seattle Quality of Life Group [ Time Frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery. ]
    The YQOL instrument assesses multidimensionally the generic quality of life of youth ages 11-18 years of age. YQOL includes both generic and condition-specific measures.
  • Achenbach System of Empirically Based Assessment (ASEBA) [ Time Frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery. ]
    The ASEBA offers a comprehensive approach to assessing adaptive and maladaptive functioning.These surveys are given to the parents of the patients in the study in order to provide a behavioural assessment of their child.
  • Periodontal measurements [ Time Frame: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery. ]
    The periodontal condition of the premolars and molars normally used for maxillary protraction are evaluated using bleeding index, plaque scores, probe depth and mobility scores.


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: May 9, 2016
Date Started: March 2015
Date Completion: May 2019
Last Updated: May 27, 2016
Last Verified: May 2016