Clinical trial NCT02789787: Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate
Official title: Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Keywords: Cleft Lip
Palate
Class III
Malocclusion
Protraction
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: Children's Hospital Los Angeles
First posted: 2016-06-03
Enrollment: 117
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
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

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 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of nonsyndromic cleft lip and palate and Class III malocclusion
* Age 11-14 for maxillary protraction, Age 16-21 for LeFort I single jaw surgery.

Exclusion Criteria:

* Cognitive delay;
* Mandibular asymmetry;
* Mandibular prognathism;
* 2-jaw cants;
* Non-grafted alveolar cleft;
* Inability or unwillingness to have clinical radiographs, photographs, or dental impressions taken;
* History of therapeeutic radiation treatment to the mazilla or mandible;
* Pregnancy; if participants become pregnant during the study they will be withdrawn.

Primary outcomes:
measure: Bite correction of digitized models.
timeFrame: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Secondary outcomes:
measure: Cephalometric radiographs
timeFrame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
measure: Facial attractive rating of photographs
timeFrame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
measure: Costs of treatments
timeFrame: At the end of approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
measure: 12-Item Short Form Health Survey (SF-12) developed by the Rand Corporation
timeFrame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
measure: Youth Quality of Life (YQOL) survey designed by the Seattle Quality of Life Group
timeFrame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
measure: Achenbach System of Empirically Based Assessment (ASEBA)
timeFrame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
measure: Periodontal measurements
timeFrame: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: CHLA
name: Stephen Yen, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Dental and Craniofacial Research (NIDCR)
name: Jane Atkinson
role: STUDY_DIRECTOR
References:
citation: Chung EH, Borzabadi-Farahani A, Yen SL. Clinicians and laypeople assessment of facial attractiveness in patients with cleft lip and palate treated with LeFort I surgery or late maxillary protraction. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1446-50. doi: 10.1016/j.ijporl.2013.05.042. Epub 2013 Jul 18.
citation: Yen SL. Protocols for Late Maxillary Protraction in Cleft Lip and Palate Patients at Childrens Hospital Los Angeles. Semin Orthod. 2011 Jun 1;17(2):138-148. doi: 10.1053/j.sodo.2011.01.001.
citation: McIlvaine E, Borzabadi-Farahani A, Lane CJ, Azen SP, Yen SL. Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion. Int J Pediatr Otorhinolaryngol. 2014 May;78(5):725-30. doi: 10.1016/j.ijporl.2014.01.006. Epub 2014 Feb 12.
citation: Borzabadi-Farahani A, Lane CJ, Yen SL. Late maxillary protraction in patients with unilateral cleft lip and palate: a retrospective study. Cleft Palate Craniofac J. 2014 Jan;51(1):e1-e10. doi: 10.1597/12-099. Epub 2012 Dec 13.