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Cleft Lip and Palate clinical trials

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NCT ID: NCT03766217 Completed - Clinical trials for Cleft Lip and Palate

Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair

CLOSE
Start date: April 5, 2019
Phase: Phase 3
Study type: Interventional

Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar cleft repair.

NCT ID: NCT03750708 Withdrawn - Clinical trials for Cleft Lip and Palate

Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate

HBD-GPP
Start date: January 28, 2019
Phase: N/A
Study type: Interventional

Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an autologous iliac bone graft. Clinical experience suggests that a large number of the post-operative complications in this procedure are related to pre-and post-operative oral hygiene issues. The main objective of this research is the evaluation of pre-operative oral hygiene in children benefiting from alveolar bone graft and having a type Quad Helix orthodontic device. The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has an influence on the occurrence of post-operative complications evaluated at 6 months of intervention (delays in scarring, suture dehiscence, fistulas, surgical site infections, total or partial graft loss).

NCT ID: NCT03740841 Terminated - Clinical trials for Cleft Lip and Palate

Evaluation of the Effects of LUNII on Pre-operative Anxiety and on the Post-operative Period in Children With Cleft Lip and Palate Admitted for Alveolar Bone Graft: Pilot Study

LUNII
Start date: January 8, 2019
Phase: N/A
Study type: Interventional

The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery. The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.

NCT ID: NCT03708406 Completed - Clinical trials for Cleft Lip and Palate

Otologic and Rhinologic Outcomes in Children With Clef Palate

Clef Palate
Start date: October 12, 2018
Phase:
Study type: Observational

OBJECTIVE: To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft. DESIGN: Monocentric retrospective and prospective analysis of medical reports. PATIENTS, PARTICIPANTS: All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years. INTERVENTIONS: Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated. MAIN OUTCOME MEASURE(S): The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.

NCT ID: NCT03686761 Completed - Clinical trials for Cleft Lip and Palate

Periodontal Changes Following Mid Maxillary Distraction

Start date: February 2015
Phase: N/A
Study type: Interventional

To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).

NCT ID: NCT03582111 Completed - Clinical trials for Cleft Lip and Palate

Ultrasound Diagnosis of Cleft Lip and Palate

FENCHU
Start date: February 2009
Phase:
Study type: Observational

Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present. The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that the diagnosis rate is constant since 2005.

NCT ID: NCT03563495 Completed - Clinical trials for Cleft Lip and Palate

Tissue Engineered Constructs for Alveolar Cleft Repair

Start date: February 2015
Phase: N/A
Study type: Interventional

Description of the research question In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting? Objective of the study: • Research hypothesis The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction. - The objectives The primary objective: Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction. The secondary objective: Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.

NCT ID: NCT03514563 Terminated - Clinical trials for Cleft Lip and Palate

Three Dimensional Facial Growth Analysis

Start date: June 1, 2018
Phase:
Study type: Observational [Patient Registry]

Cleft lip and palate is the most common facial birth defect affecting one in 700 babies, and frequently leads to problems in feeding, breathing, speech and/or hearing, and aesthetic problems often leading to social and psychological problems. Poor growth of the upper jaw affects nearly all patients with the condition, and can result in substantial misalignment of the teeth requiring corrective surgery and associated dental treatment in early adulthood. Surprisingly there is little evidence to support the current practice of delaying surgery until early adulthood. It is apparently left until then because it is assumed this is when the skull and face have stopped growing, but there is little available information on that growth and when the different parts of the face and skull stop growing. The goal of this study is to develop and test new computer-based methods to quantify skull growth and related soft- tissues changes. This pilot work will demonstrate whether it is possible to measure these developments and prepare the tools for a larger clinical study. That clinical study will determine the full nature and extent of bone growth and related soft-tissue changes during late adolescence, to identify if/when earlier surgery could be carried out to correct any deformity and minimise the associated social stigmas of the condition.

NCT ID: NCT03395015 Completed - Clinical trials for Cleft Lip and Palate

Efficacy of Maxillo-facial Treatment on Cleft Lip and Palate Patients Faces: Aesthetic Considerations

Start date: June 5, 2017
Phase: N/A
Study type: Observational

The aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft lip and palate (CLP) patients. The aim of the study is to identify differences in the aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople.

NCT ID: NCT03308266 Completed - Clinical trials for Temporomandibular Disorder

Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders

Start date: May 2015
Phase: N/A
Study type: Observational

The aim of this study was to assess the electrical activity of the temporal and masseter muscles in cleft lip and palate (CLP) children with pain-related temporomandibular disorders (TMD) and in CLP individuals with no TMD by means of surface electromyography (sEMG). Another objective was to determine the diagnostic value of electromyography in identifying CLP patients with temporomandibular disorders. The sample comprised 87 children with CLP and mixed dentition. The children were assessed for the presence of TMD using of the Research Diagnostic Criteria for TMD (RDC/TMD) by a single examiner. A DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the temporal and masseter muscles both in the mandibular rest position and during maximum voluntary contraction (MVC).