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	Treatment or Intervention	Phase
Cleft Lip Cleft Palate	Procedure: Lip revision surgery	Phase II Phase III

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

1. In a prospective non-randomized controlled clinical trial, evaluate the efficacy of lip revision surgery by a) Examining longitudinal changes in function after lip revision, and b) Examining whether the change in function after lip revision differs from the change that would be observed due to maturation only in the matched non-cleft 'normal' group, and the change in the cleft but non-lip revised group.

2. a) Estimate the effect of cleft lip and palate on function after primary lip and palate repair but prior to lip revision surgery by comparing those patients scheduled to receive a lip revision with those who are judged not to need a lip revision, and b) Estimate the impairment in function in cleft lip and palate patients without lip revision relative to matched non-cleft subjects.

3. Compare the assessments of dynamic lip function provided by objective measures with subjective clinical judgments/ratings of craniofacial plastic surgeons who perform lip revision surgery, and evaluate the potential of the new methods for clinical application.

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.

Ages Eligible for Study:  5 Years   -   21 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Cleft lip and palate revision and non-revision patients.

Inclusion criteria:

• A previously-repaired complete unilateral or bilateral cleft lip and cleft palate;
• For the lip revision patients, the professional clinical recommendation by the Center's craniofacial plastic surgeon for a full-thickness lip revision;
• Patient interest / parent willingness to participate in the study;
• An ability to comprehend verbal instructions; and
• An age range of 5-17 yrs.

Exclusion criteria:

• The presence of an isolated cleft lip;
• Previous lip-revision surgery or other facial soft-tissue surgery;
• Previous orthognathic surgery;
• A diagnosis of a craniofacial anomaly other than cleft lip and palate;
• A medical history of diabetes, collagen vascular disease, systemic neurologic impairment; or
• Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered.

Non-cleft subjects.

Inclusion criteria:

• Patient interest / parent willingness to participate in the study;
• An ability to comprehend verbal instructions; and
• An age range of 5-17 yrs.

Exclusion criteria:

• Previous orthognathic or facial soft-tissue surgery;
• A medical history of diabetes, collagen vascular disease, systemic neurologic impairment; or
• Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered.

Carroll Trotman, DDS      919-843-9760    Carroll-Ann_Trotman@dentistry.unc.edu

North Carolina
      The University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599-7450,  United States; Recruiting

Study chairs or principal investigators

Carroll Trotman, DDS,  Principal Investigator,  University of NC at Chapel Hill   

Study ID Numbers:  NIDCR-13814
Record last reviewed:  October 2004
Record first received:  October 8, 2003
ClinicalTrials.gov Identifier:  NCT00070811
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08