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COMPLETED

Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate

NCT02789787 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • PROCEDURE Maxillary Protraction
  • PROCEDURE Orthognathic Surgery

Study Locations (2)

California

  • Children's Hospital Los Angeles — Los Angeles

Washington

  • Seattle Children's Hospital — Seattle

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2015-04-29
Est. Completion 2021-05-31

Sponsor

University of Southern California

412 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02789787

The ClinicalTrials.gov registry entry for NCT02789787 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 412 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cleft Lip and Palate appearing as the primary indexed condition, and to 2 interventions — of which Maxillary Protraction is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02789787 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02789787 about?

NCT02789787 is a clinical study titled "Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate". 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),...

What is the current status of trial NCT02789787?

This trial is currently completed. The enrollment target is 117 participants. The study started on 2015-04-29. Estimated completion is 2021-05-31.

What conditions does trial NCT02789787 study?

This clinical trial studies the following conditions: Cleft Lip and Palate. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02789787?

The interventions under investigation include: Maxillary Protraction (PROCEDURE), Orthognathic Surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02789787?

This trial is sponsored by University of Southern California, which has 412 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02789787 being conducted?

This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial