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NCT02789787 · ClinicalTrials.gov registry record
Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate
A clinical trial of Cleft Lip and Palate, sponsored by University of Southern California.
- Completed
- Registry status
- 117
- Enrollment target
- 2
- Study locations
NCT02789787: Completed study of Cleft Lip and Palate, sponsored by University of Southern California.
NCT02789787 is a study of Cleft Lip and Palate that has completed, run by University of Southern California. The registered enrollment target is 117 participants, below the 200-participant average among 5 other Cleft Lip and Palate trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02789787, a study of Cleft Lip and Palate, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- 117 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2015-04-29 |
| Est. Completion | 2021-05-31 |
What the finished NCT02789787 record still lists
NCT02789787 is an observational study that tracks outcomes without assigning an intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 200-participant average among 5 other Cleft Lip and Palate trials with a reported enrollment target (41% lower).
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.
NCT02789787 reports a single indexed study location in California, Washington.
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.
What interventions are being tested in trial NCT02789787?
The interventions under investigation include: Maxillary Protraction (PROCEDURE), Orthognathic Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT02789787?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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.
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