Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00070811
Recruitment Status : Completed
First Posted : October 13, 2003
Last Update Posted : July 4, 2013
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Carroll-ann Trotman, DDS, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date October 8, 2003
First Posted Date October 13, 2003
Last Update Posted Date July 4, 2013
Study Start Date August 2001
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 2, 2012)
Facial movement/animation [ Time Frame: 6 ]
Original Primary Outcome Measures
 (submitted: June 23, 2005)
Facial animation
Change History
Current Secondary Outcome Measures
 (submitted: August 2, 2012)
  • Lip Force [ Time Frame: 6 ]
  • EMG [ Time Frame: 6 ]
  • Lip sensation [ Time Frame: 6 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate
Official Title Functional Outcomes of Cleft Lip and Lip Revision Surgery
Brief Summary 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.
Detailed Description

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.
  4. Evaluate whether objective information when added to the clinician's subjective evaluation of a patient alters the surgical treatment plan or the goals of treatment when subjective and objective information are incorporated in the decision-making and treatment planning process. This specific aim will be useful in adapting and assessing the potential of the new objective methods for application in a clinical setting.
  5. To establish 'parameters of care' criteria for secondary lip revision treatment decision-making based on standardized, systematic subjective evaluation, and an objective measurement of movement capacity during function of the upper lip.
  6. Assess the long-term effects of maturation on function following lip revision by continuing data-collection beyond the one-year post-revision on patients recruited during the period of the initial grant and long-term follow-up (18 and 30 months) on newly recruited lip revision patients, and in so doing, evaluate the efficacy of cleft lip revision surgery.

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 40-year history of strong commitment to the care of these patients and craniofacial research, all favor success in meeting the goals of the project.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects will be recruited and screened mainly in the UNC Craniofacial Center, the Graduate Orthodontic Clinic, the Pediatric Dentistry Clinic, and the Orthodontic Faculty Practice of the University of North Carolina.
Condition
  • Cleft Lip
  • Cleft Lip and Palate
Intervention Procedure: Lip revision surgery
Full or partial muscle thickness lip revision surgery.
Other Names:
  • Primary lip repair
  • Secondary lip repair
Study Groups/Cohorts
  • Revision
    Patients with repaired cleft lip who receive lip revision surgery
    Intervention: Procedure: Lip revision surgery
  • Non-Revision
    Patients with repaired cleft lip who do not have lip revision surgery
  • Non-cleft
    Non-cleft 'control' subjects.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 2, 2013)
127
Original Enrollment
 (submitted: June 23, 2005)
130
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria
  1. Children:

    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.
  2. Infants

Cleft lip and palate patients.

Inclusion Criteria:

  • The professional clinical recommendation by the Center's craniofacial plastic surgeon for a cleft lip repair surgery;
  • Parent willingness to have baby participate in the study;
  • An age range of 0-6 months.

Exclusion Criteria:

  • Has had surgery for any reason
  • A diagnosis of a craniofacial anomaly other than cleft lip and palate;
  • A medical history of diabetes, collagen vascular disease, and systemic neurologic impairment

Non-cleft subjects.

Inclusion Criteria:

  • Parent willingness to have baby participate in the study;
  • An age range of 0-6 months.

Exclusion Criteria

  • Has had surgery for any reason including bone surgery
  • A medical history of diabetes, collagen vascular disease, and systemic neurological impairment
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Months to 21 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00070811
Other Study ID Numbers NIDCR-13814
R01DE013814 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carroll-ann Trotman, DDS, University of North Carolina, Chapel Hill
Study Sponsor University of North Carolina, Chapel Hill
Collaborators National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Carroll-Ann Trotman, BDS, MA, MS University of NC at Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date July 2013