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| Sponsor: | National Institute of Dental and Craniofacial Research (NIDCR) |
|---|---|
| Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
| ClinicalTrials.gov Identifier: | NCT00070811 |
Purpose
The purpose of this study is to determine whether secondary (revision) surgery to the lip in patients with cleft lip and palate is effective in improving lip function and appearance.
| Condition | Intervention | Phase |
|---|---|---|
|
Cleft Lip Cleft Palate |
Procedure: Lip revision surgery |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Functional Outcomes of Lip Revision |
| Estimated Enrollment: | 130 |
| Study Start Date: | August 2001 |
| Estimated Study Completion Date: | May 2005 |
Children born with clefting of the upper lip exhibit obvious disfigurement of the upper lip and nose. As illustrated below, primary lip surgery of the infant dramatically improves the severe deformity of the perioral and nasal region. It is widely recognized, however, that most patients require additional lip surgeries for an optimum esthetic result. Clinicians often disagree as to when this end point is reached since the decision for additional lip revision is based on subjective clinical assessments.
Facial morphology during function has a major impact on how a person is perceived in society and is known to be an important component of the esthetic outcome for cleft patients, but it has been particularly difficult to incorporate measures of lip function into the decision-making process. It is likely that the different surgical procedures for both primary lip closure and secondary lip revision could be improved if the effects of alternative surgical techniques on function were better understood. The subjects for this project consist of two cleft lip and palate patient groups treated at the University of North Carolina (UNC) Craniofacial Center: one cleft group will be patients who are candidates for additional lip revision surgery; the other cleft group will be patients who have been judged not to need lip revision; and a matched non-cleft group who present for routine dental care at UNC School of Dentistry. The goals of this project are to objectively measure and quantify functional facial impairment in cleft patients, and to establish more reliable, functionally relevant outcome criteria for treatment planning and evaluation of these individuals. Our specific aims, therefore, are to
To address these aims, we have identified a group of highly qualified individuals with widely recognized expertise in the application of the proposed methodologies, and a panel of surgeons experienced in cleft care for clinical evaluation of outcomes. This expertise, the availability of an appropriate patient resource, and the home institution's 35-year history of strong commitment to the care of these patients and craniofacial research, all favor success in meeting the goals of the project.
Eligibility| Ages Eligible for Study: | 5 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Cleft lip and palate revision and non-revision patients.
Inclusion criteria:
Exclusion criteria:
Non-cleft subjects.
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, North Carolina | |
| The University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7450 | |
| Principal Investigator: | Carroll Trotman, DDS | University of NC at Chapel Hill |
More Information
| Study ID Numbers: | NIDCR-13814 |
| Study First Received: | October 8, 2003 |
| Last Updated: | September 14, 2006 |
| ClinicalTrials.gov Identifier: | NCT00070811 History of Changes |
| Health Authority: | United States: Federal Government |
|
Facial form Facial animation |
|
Mouth Diseases Cleft Lip Craniofacial Abnormalities Jaw Diseases Stomatognathic System Abnormalities Maxillofacial Abnormalities Lip Diseases |
Musculoskeletal Abnormalities Cleft Palate Musculoskeletal Diseases Mouth Abnormalities Jaw Abnormalities Stomatognathic Diseases Congenital Abnormalities |