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Cleft Lip 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NCT ID: NCT03750708 Withdrawn - Clinical trials for Cleft Lip and Palate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: NCT03683199 Completed - Nose; Anomaly Clinical Trials

Objective Assessment for Cleft Lip Nasal Deformity Correction

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

Rhinoplasty remains one of the most challenging procedures in plastic surgery, and patients with cleft lip nasal deformity pose an even greater challenge, in which biggest issue is to achieve caudal nose harmony and creation of symmetrical nostrils with patent normal nasal function

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: NCT03572907 Withdrawn - Cleft Palate Clinical Trials

Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact.

PETROL/TROPHIC
Start date: October 2018
Phase:
Study type: Observational

The patients in this study are all born with a cleft lip and palate. They underwent several interventions in childhood to take care of it. Professor Gleizal offered them a secondary rhinoplasty aimed at normalizing the appearance of their nose. In this malformative and multioperated context, typical nasal deformities affect the tip of the nose, which appears to be sagging and asymmetrical. Scarred soft tissues exert an important retractile force against which conventional rhinoplasty techniques often remain insufficient. The use of columellar struts makes it possible to give again projection to the tip of the nose but when this strut is made from cartilage or bone, it is absorbed with the time. Moreover, these interventions require a remote removal of the site of interest (costal cartilage, tibial crest, calvaria) which generates additional morbidity. The investigators propose an alternative using a synthetic graft of titanium. This material has been used for many years for its excellent biocompatibility and trauma resistance. 28 patients were able to benefit from this technique between March 1, 2016 and March 1, 2018. The investigators wish to evaluate the aesthetic and functional results from the patient's point of view by submitting them to one validated rhinoplasty questionnaire after the end of the patient's inclusion.

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: NCT03537976 Recruiting - Cleft Palate Clinical Trials

Targeting Surgeons' Decision-Making for Cleft Lip Surgery

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

Using separate prospective cohorts of patients who have lip revision and lip repair surgery, the objective of this clinical trial is to both qualitatively and quantitatively assess how surgeons integrate the objective measures and visual aids of the Intervention with the systematic subjective assessment in order to determine decisions surgery.