Research - Clinical Studies
Clinical Study Title
Functional Outcomes of Cleft Lip Surgery
****** Not currently enrolling new participants in this Clinical Study. ******
Description/Purpose of the Study
The purpose of this study is to measure (1) how your child’s face and lips look at rest and during various facial movements, (2) the force your child can make when he/she presses his/her lips together, and (3) the feelings on and around your child’s lips.
|IRB Study #:||99-1209 Formerly (DENT-3166)|
|Principal Investigator:||Dr. Carroll-Ann Trotman, BDS, MA, MS|
You or your child may be eligible to participate if you/they have:
Cleft of the lip ± palate: Newly-enrolled and previously-enrolled patients with a cleft of the lip ± palate:
A previously repaired unilateral or bilateral cleft of the lip and alveolus only; a previously repaired unilateral or bilateral cleft of the lip and palate; for the lip revision patients, the recommendation by the Center’s craniofacial plastic surgeon for lip revision; patient interest / parent willingness to participate in the study; an ability to comprehend verbal instructions; an age range of 5-21 years.
Non-cleft: Previously enrolled non cleft subjects:
Enrolled in the initially funded part of this study; subject interest / parent willingness to participate in the study; an ability to comprehend verbal instructions; an age range of 5-21 years.
You or your child should not participate if you/they have:
A history of soft tissue facial surgery other than cleft lip surgery including lip revision or orthognathic bone surgery.
A previous lip revision surgery within past 2 years (except for the previously enrolled subjects who have received lip revision surgery while participating in the study).
A diagnosis of a facial problem other than cleft of the lip and palate.
A medical history of diabetes, collagen vascular disease, or systemic neurological impairment.
A mental or hearing problem to the extent that you or your child is unable to follow instructions.