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Unilateral Cleft Lip clinical trials

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NCT ID: NCT06127953 Recruiting - Clinical trials for Unilateral Cleft Lip

Intermediate Cleft Rhinoplasty in Unilateral Cleft Lip Patients: Approaches and Outcomes

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

This is a prospective study of 20 patients with unilateral cleft lip nasal deformity. The technique to be performed is open approach intermediate rhinoplasty using a hybrid technique combining Potter, Dibbell, and Tajima methods as needed (Potter 1954, Tajima and Maruyama 1977, Dibbell 1982). Lip revision will be performed with the intermediate cleft rhinoplasty according to the lip deformity if needed. Aim of the work is To propose an algorithmic approach for management of unilateral cleft lip nasal deformity using hybrid techniques of intermediate cleft rhinoplasty and to assess the aesthetic and functional outcomes. All the regulations of the ethical committee of the faculty of medicine in Sohag University will be followed. Each patient will have a private file with a non-disclosure policy at data presentation where all presented data do not contain any personal information specifying the identity of any of the patients. Informed written consent will be taken from all patients in the study. Regarding patients' assessment, the following items will be fulfilled: Full medical and operative history. Complete physical examination. Nasal examination, including nasal analysis, anterior rhinoscopy, Cottle maneuver, modified Cottle maneuver, and possibly endoscopic examination to fully assess any functional problems. Routine laboratory investigations Standard preoperative photographs (frontal, lateral and basal). Surgery follow up will be at 1 week ,1 month, 3 months, 6 months and 1 year and postoperative photographs will be taken.

NCT ID: NCT05081258 Recruiting - Clinical trials for Cleft Lip and Palate

Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Orofacial clefts are the second most common birth deformity and vary in etiology and phenotype, e.g. isolated cleft palate, cleft lip or cleft lip palate. Especially newborns with unilateral complete cleft lip and palate (UCLP) present severe facial asymmetries auch as a broad and flat ala of the nose, a deviation of the columella and the philtrum to the non cleft side. Since postnatal asymmetries can even remain after surgical lip closure in a alleviated shape, therapeutic presurgical orthodontic approaches to improve symmetrie of the nose and to achieve ideal conditions for lip surgery are essential. Presurgical orthodontic treatment for newborns with UCLP start within the first days after birth to separate oral and nasal cavitiy, to improve breathing and feeding and to regulate growth of the maxillary segments using passive appliances (passive Alveolar Molding (pAM)). An advanced and widely spread concept is the Nasoalveolar Molding (NAM) by Grayson, which was first introduced in 1993 as a palate plate combined with a nasal stent as a non-invasive presurgical appliance to stimulate growth of the nose and use the postnatal potential to modulate the nasal cartilage. The aim of the NAM therapy is to reduce nasal width, to reduce deviation of the columella to the non cleft side and to increase nostril height. However, due to inhomogeneous study designs and results, so far only a slightly positive effect using NAM therapy could be detected and prospective, randomized clinical trials are necessary. The aim of the study is to analyse and to compare the effects of pAM versus NAM treatment in newborns with UCLP in the first year of life. The following parameters will be analysed on defined study time points: nostril width, nasal morphology, cleft width, maxillary growth, statical and dynamical facial asymmetries and facial perception.