Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate

NCT02789787 | Completed DMC

• 1 other identifier: 5U01DE022937-04
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 2

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.

Conditions

Cleft Lip and Palate

Keywords

Cleft Lip; Palate; Class III; Malocclusion; Protraction

Outcome Measures

Primary Outcomes (1)

• Bite correction of digitized models.

  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.

  Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.

Secondary Outcomes (7)

• Cephalometric radiographs

  The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.

• Facial attractive rating of photographs

  The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.

• Costs of treatments

  At the end of approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.

• 12-Item Short Form Health Survey (SF-12) developed by the Rand Corporation

  The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.

• Youth Quality of Life (YQOL) survey designed by the Seattle Quality of Life Group

  The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.

Study Arms (2)

Maxillary protraction

Early adolescents (11 - 14 yrs) with cleft lip and palate and Cl III malocclusion

Procedure: Maxillary Protraction

Orthognathic surgery

Late adolescents to young adults (16-21 years) with cleft lip and palate and Cl III malocclusion

Procedure: Orthognathic Surgery

Interventions

Maxillary Protraction PROCEDURE

"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.

Maxillary protraction

Orthognathic Surgery PROCEDURE

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.

Also known as: LeFort 1 maxillary advancement surgery

Orthognathic surgery

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with nonsyndromic cleft lip and palate who have a Cl III malocclusion

You may qualify if:

• 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.

You may not qualify if:

• Cognitive delay;
• Mandibular asymmetry;
• Mandibular prognathism;
• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Seattle Children's Hospital: collaborator
• Children's Hospital Los Angeles: collaborator

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Seattle Children's Hospital

Seattle, Washington, 981105, United States

Location

Related Publications (4)

• 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.

  PMID: 23871270 BACKGROUND

• 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.

  PMID: 21765629 BACKGROUND

• 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.

  PMID: 24630053 BACKGROUND

• 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.

  PMID: 23237432 RESULT

MeSH Terms

Conditions

Cleft Lip; Malocclusion

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Diseases

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Stephen Yen, DMD, PhD

  CHLA

  PRINCIPAL INVESTIGATOR

• Jane Atkinson

  National Institute of Dental and Craniofacial Research (NIDCR)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: June 3, 2016
• Study Start: April 29, 2015
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (2)