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Cleft Lip clinical trials

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NCT ID: NCT05331456 Recruiting - Clinical trials for Cleft Lip and Palate

Alveolar Cleft Repair Using Osteoinductive Ceramics

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

In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.

NCT ID: NCT05102513 Recruiting - Clinical trials for Complete Unilateral Cleft Lip

Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

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

Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. In this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. However, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. The result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. In order to compensate for these "deficiencies", a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening. However, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. In addition, it often provides a step formation within the white roll. Knowing the weaknesses of the previous techniques, a further development of the incision was made. The rotational flap of the Millard II technique was extended by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was extended by a wave incision as known from the Pfeifer procedure.

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.

NCT ID: NCT05009472 Recruiting - Clinical trials for Cleft Lip and Palate

Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients

Start date: June 26, 2021
Phase: N/A
Study type: Interventional

maxillary expansion in cleft palate patient with expander and using face mask.

NCT ID: NCT04997083 Recruiting - Clinical trials for Cleft Lip and Palate

Slow Expansion and Protraction in Cleft Lip and Palate Patients

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

NCT ID: NCT04970095 Recruiting - Clinical trials for Cleft Lip and Palate

Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

NCT ID: NCT04966572 Recruiting - Clinical trials for Cleft Lip and Palate

Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.

NCT ID: NCT04771156 Recruiting - Clinical trials for Cleft Lip and Palate

Ketorolac in Palatoplasty

Start date: September 17, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively

NCT ID: NCT04619030 Recruiting - Breast Cancer Clinical Trials

Augmented Reality (AR): The Future of "Patient Information Leaflets

Start date: November 30, 2020
Phase: N/A
Study type: Interventional

This project aims to assess a new type of Augmented Reality Patient Information leaflet, in order to demonstrate that it is a beneficial information resource to patients when facing the diagnosis of sarcoma, breast cancer or to explain difficult concepts such as cleft lip repair. There are no published studies on the use of AR in patient leaflets.

NCT ID: NCT04455035 Recruiting - Clinical trials for Cleft Lip and Palate

DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants

Start date: September 21, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.