An observational study in Cleft Lip, Unilateral, sponsored by Assiut University. Not yet recruiting. Open to participants aged 3 Months to 6 Months. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by Assiut University · Observational
"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.
One of the common congenital malformations in the head and neck is cleft lips. The prevalence of cleft lip is about 1:1000 of live birth; it also more common in boys and tends to present on the left side with a 6:3:1 ratio of left to right to bilateral. Many facial malformations, including cleft lip, are linked with environmental, maternal, and genetic factors, such as exposure to teratogen drugs, including isotretinoin, alcohol, or anticonvulsants. Similarly, some habits or diseases during pregnancy increase the risk of the cleft lip as smoking, pregestational and gestational diabetes, and specific nutritional deficiencies. The treatment begins soon after the child's birth and continues until adulthood. The purpose of cleft treatment is aesthetic and functional rehabilitation. Surgical repair is important for facial growth preservation, normal speech formation and development of proper dentition. The less number of interventions, the less the scaring results and hence, growth retardation Nowadays, the most commonly used techniques in managing unilateral cleft lip (UCL) are Millard's rotation advancement and Tennison Randall's triangular flap repairs. This study aimed to use anthropometric analysis by anthropometric measurements taken pre and post operation to evaluate the quantitative assessment of the modified Millard technique compared with the Tennison Randall technique in UCL repair.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 49 observational studies indexed under Cleft Lip.
Browse Cleft Lip studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients with complete and incomplete unilateral cleft lip.
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Exclusion Criteria:
Patients who will be subjected to Millard Technique
Procedure: Millard and Tension Randal Technique
patients who will be subjected to Tension Randal
Procedure: Millard and Tension Randal Technique
Millard recognized that the majority of Cupid's bow, one philtral column, and the philtral dimple were intact on the medial aspect of a unilateral cleft lip but required rotation to shift the tissue into a normal anatomic position (Millard, 1964b) The Tennison-Randall technique involves a back-cut that extends from the cleft Cupid's bow peak toward the center of the philtrum that is filled by a laterally based triangular flap whose width is the measured deficiency in lip height.
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.
Time frame: 6 months
No study locations are listed for this record.
Start is estimated for Dec 2024; primary completion for Nov 2025, 11 months later.
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This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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