Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Observational

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 description: 
      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 procedures. The two study groups differ in age and treatment. One group of
      patients, ages 11 -14 years of age, chose to undergo maxillary protraction via sutural
      loosening for correction of Cl III malocclusion. The other group of patients, ages 16 and 21
      years, elected to undergo orthognathic surgery for correction of Cl III malocclusion.

      Study Methodology: This is a non-randomized prospective parallel cohort study that follows
      the treatment outcomes of approximately 100 patients with cleft lip and palate and Cl III
      malocclusion who are treated with maxillary protraction at about a maximal age of 14 years
      (target N=50) vs. orthognathic surgery at a maximal age of 21 years (target N=50).

      Description of Treatment Arms: The first treatment arm consists of participants who have
      chosen to undergo the orthodontic (non-surgical) maxillary protraction procedure. The second
      treatment arm consists of participants who have chosen to undergo the orthognathic (jaw)
      surgical procedure.

      Outcomes: The outcomes measured in both groups will be bite correction (GOSLON yardstick),
      facial esthetics, changes in cephalometric x-ray measurements, youth quality of life (YQOL),
      psychological/behavioral assessment surveys (ASEBA), cost, periodontal health, complications
      and stability of treatment.

      Follow-up: Participants in both arms of the study (protraction vs. surgery) will have data
      collected prior to, during, immediately after, and 1 year after treatment.

      Statistics and Plans for Analysis: The % of patients requiring further surgery and the
      reasons for the relapse or incomplete treatment will be examined using the collected data.
      The investigators will examine factors that are associated with the successful outcomes for
      each treatment and adjust for these factors in the models.
    

Intervention name(s): Maxillary Protraction; Orthognathic Surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): "Maxillary protraction" is an alternative non-surgical approach to correct the Cl III malocclusion. 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 maxilla to be protracted in order to correct the underbite. This treatment is offered to the patients, age 11-14, who have the Cl III malocclusion with or without cleft lip and palate.; The orthognathic surgery is the current standard of care for treating the Cl III malocclusion after pubertal growth. This treatment is offered to the patients, after pubertal growth, who have the Cl III malocclusion with or without cleft lip and palate.
Other intervention name(s): LeFort 1 maxillary advancement surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with nonsyndromic cleft lip and palate who have a Cl III malocclusion
      
Keywords: Cleft Lip; Palate; Class III; Malocclusion; Protraction