Cleft Lip, Unilateral Clinical Trial
Official title:
Comparative Study Between Millard and Tennison Randall Techniques in Complete and Incomplete Cleft Lip Repair.
"the investigators will compare the quantitative and qualitative (functional and aesthetic outcomes) of these two surgical approaches for repair of the unilateral cleft lip using an evaluation protocol developed many years ago by the research council of Operation Smile, a non- profit organization based in Virginia Beach, USA. Operation Smile delivers charity management of cleft lip and palate cases in many different developing countries around the world. Under this protocol, a dual rating system has been developed with two scores: one preoperative score concerning the severity of cleft and one score for the postoperative results.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2025 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 3 Months to 6 Months |
Eligibility | Inclusion Criteria: - Patients are generally fit - Patients with unilateral with or without cleft palate - Patients with compliance for follow up. Exclusion Criteria: - Syndromic cases. - Patients are generally unfit. - Secondary cleft lip. - Age less than 3 months, more than 4 years - Bilateral cleft lip. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Jones MC. Facial clefting. Etiology and developmental pathogenesis. Clin Plast Surg. 1993 Oct;20(4):599-606. — View Citation
Parker SE, Mai CT, Strickland MJ, Olney RS, Rickard R, Marengo L, Wang Y, Hashmi SS, Meyer RE; National Birth Defects Prevention Network. Multistate study of the epidemiology of clubfoot. Birth Defects Res A Clin Mol Teratol. 2009 Nov;85(11):897-904. doi: — View Citation
Willhite CC, Hill RM, Irving DW. Isotretinoin-induced craniofacial malformations in humans and hamsters. J Craniofac Genet Dev Biol Suppl. 1986;2:193-209. — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Primary | functional and aesthetic outcomes after repair | two scores: one preoperative score concerning the severity of cleft and one score for the Assessment of the results based on the post-operative scoring sheet included items for evaluating the integrity and symmetry of the Cupid's bow, nasal symmetry, lateral lip symmetry, vermilion contour, and white roll continuity. The individual scores for each factor were combined to yield an overall rating of poor, fair, good, and excellent. | 6 months |
Status | Clinical Trial | Phase | |
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Recruiting |
NCT03891719 -
Correction of the Unilateral Cleft Lip Nasal Deformity With Sliding Chondrocutaneous Flap and Autologous Cartilage Graft
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N/A |