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

July 2, 2013 updated by: Carroll-ann Trotman, DDS, University of North Carolina, Chapel Hill

Functional Outcomes of Cleft Lip and Lip Revision Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Revision
Patients with repaired cleft lip who receive lip revision surgery
Procedure: Lip revision surgery
Full or partial muscle thickness lip revision surgery.
Other Names:
  • Primary lip repair
  • Secondary lip repair
Non-Revision
Patients with repaired cleft lip who do not have lip revision surgery
Non-cleft
Non-cleft 'control' subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Facial movement/animation
Time Frame: 6
6

Secondary Outcome Measures

Outcome Measure
Time Frame
Lip Force
Time Frame: 6
6
EMG
Time Frame: 6
6
Lip sensation
Time Frame: 6
6

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

October 8, 2003

First Submitted That Met QC Criteria

October 10, 2003

First Posted (ESTIMATE)

October 13, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

July 4, 2013

Last Update Submitted That Met QC Criteria

July 2, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCR-13814
  • R01DE013814 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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