Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate

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

Interventions

PROCEDURE

Maxillary Protraction

"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.

PROCEDURE

Orthognathic Surgery

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.

Sponsors & Collaborators

• Seattle Children's Hospital

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• University of Southern California

  lead OTHER

Principal Investigators

• Stephen Yen, DMD, PhD · CHLA

• Jane Atkinson · National Institute of Dental and Craniofacial Research (NIDCR)

Eligibility

Min Age

11 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-04-29

Primary Completion

2021-05-31

Completion

2021-05-31

Countries

• United States

Study Locations