Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate
Completed
Conditions studied: Cleft Lip, Cleft Lip and Palate
In brief
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.
Key facts
- Study ID
- NCT00070811
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 127
- Starts
- 2001-08-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2013-07-04
Who can join
Age: 0 and older, up to 21. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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
Where it is running
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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