View clinical trials related to Cleft Palate.
Filter by:Phase I/II, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.
Children born with a cleft lip and palate (CLP) are known to be at risk for speech-language disorders that impact academic and social emotional growth. Even at very young ages (<3 years), speech-language disorders are already observed. It is hypothesized that speech-language intervention delivered before the age of 3 years old could decrease the impact of CLP on speech-language development. This would result in a decreased need for speech-language therapy on the long-term and a reduced burden of care on children, families and health services. However, no evidence is yet available to support any specific model of early speech-language intervention in this population. Consequently, no standardized clinical practice guidelines are available yet. Symbolic gesture training in combination with verbal input expands the natural communication of young children including multimodal speech-language input (i.e., verbal and manual input) via caregivers who act as co-therapists. To contribute to the evidence-based practice in the field of cleft speech therapy, this research project aims to determine the effectiveness and feasibility of symbolic gesture training in one-year old children with CLP by comparing different intervention approaches based on perceptual, psychosocial and qualitative outcome measures.
Speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project. The first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (CSC). Many speech therapists use a 'one-size-fits-all' approach to treat compensatory CSCs resulting in poor short- and long-term speech outcomes. To increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of CSC. Therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in Dutch speaking children with different types of CSCs. The second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. To date, research mainly focused on immediate therapy effects. It is unknown if permanent speech changes occur. Hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective. This proposal will improve evidence-based and patient-tailored cleft speech therapy.
Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).
Cleft lip and/or palate (CL/P) is the most common congenital malformation, with about one in 500 children born with CL/P in Sweden, corresponding to approximately 175 births annually. Depending on the extent of the cleft palate, the degree of functional loss varies, but both eating, hearing, speech, bite and appearance can be affected. Patients treated for isolated or combined cleft palate may suffer from velopharyngeal insufficiency (VPI), which means difficulties in closing the passage between the oral and nasal cavities during speech. Velopharyngeal insufficiency is associated with hypernasality, audible nasal air leakage and weak articulation, which might lead to difficulties with communication and social stigmatization. The most common form of speech-improving surgery is a posterior based velopharyngeal flap, creating a bridge between the palate and the posterior pharyngeal wall to more easily compensate for the abnormal airflow through the nose during speech. However, surgical management of VPI is challenging, with variable success rates reported in the literature. In a retrospectively based questionnaire study on patients who underwent surgical treatment of VPI, 30% experienced only a small speech improvement or no improvement at all. In addition, postoperative speech impairment have also been reported, as well as perioperative bleeding and postoperative sleep apnea. Thus, selecting the patients who benefit most from speech-improving surgery is therefore of great importance. The aim with the current study is evaluation of speech function through patient- and parent-response outcome measurements following surgical treatment of velopharyngeal insufficiency in children with isolated or combined cleft palate.
Ultrasound-guided suprazygomatic maxillary nerve block (SMNB) will be performed in paediatric patients with or without the aid of ultrasound guidance. Magnetic resonance imaging (MRI) is used to visualize the spread of the local anaesthetic (LA) spread after suprazygomatic injection and to verify LA contact with the maxillary nerve in the pterygopalatine fossa (PPF).
The purpose of this study is to establish a registry of individuals with confirmed or suspected Chopra-Amiel-Gordon Syndrome (CAGS) to learn more about the range of symptoms, changes in the structure of the brain seen on imaging, and learning difficulties that individuals with this disorder may experience. The investigators will obtain medical history, family history, MRI records, patient photographs, and genetic test results from individuals with confirmed or suspected CAGS. A subset of participants will also undergo a standardized neurobehavioral assessment. This data will be maintained on a secure research database. Sample collection will be offered to participants for the functional testing and the generation of iPSC cell lines, for neuronal reprogramming and phenotyping.
Palatal fistulas are a major burden to surgeons and patients in the management of cleft palate. Their high rate of occurrence and recurrence makes them particularly challenging even to the highly skilled surgeon. Prevention of postoperative palatal fistula is therefore of paramount importance. Closure of the nasal mucosa under tension has been proposed as a major cause of palatal fistula formation. However, depending on the presentation of the cleft palate, it may be impossible to achieve surgical closure with minimal tension. Till date, there is no universally acceptable method of preventing palatal fistula formation following cleft palate repair. And although the use of pre-surgical appliances such as Latham appliance and the use of local and distant tissues to achieve two layer closure have been proposed, the use of a superpositional collagen graft may also be used to achieve closure of the nasal mucosa with minimal or no tension during cleft palate repair. Collagen grafts have the added advantage of being more patient friendly compared to the Latham appliance which requires an initial surgery for appliance insertion before surgical cleft palate repair. They are also less technique sensitive compared to the use of local and distant tissues. The investigators therefore aim to provide high level scientific evidence of the effectiveness of collagen graft in the prevention of postoperative palatal fistula.
This study will be conducted to compare Ketodex versus opioid based anaesthesia in cleft palate repair surgeries .
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.