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Cleft Lip clinical trials

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NCT ID: NCT02329509 Completed - Cleft Palate Clinical Trials

Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients

Start date: January 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate which surgical protocol for treating Unilateral Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure) will have less impact in mid facial growth. The study hypothesis states that a two stage cleft palate repair , with a late hard palate repair will reduce maxillary growth impairment.

NCT ID: NCT02247193 Completed - Cleft Palate Clinical Trials

Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair

Start date: December 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar

NCT ID: NCT01932164 Completed - Clinical trials for Cleft Lip and Palate

Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients

Start date: May 2013
Phase: N/A
Study type: Interventional

The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and quantitative analysis of bone neoformation.

NCT ID: NCT01820689 Completed - Clinical trials for Bilateral Complete Cleft Lip and/or Alveolus

Tympanometric Analysis in Cleft Palate

Start date: January 2012
Phase: N/A
Study type: Interventional

Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.

NCT ID: NCT01380171 Completed - Cleft Palate Clinical Trials

Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes

Start date: February 2007
Phase: N/A
Study type: Observational

Children who are born with cleft palate need surgery in order to correct the problem. The surgery is needed because the defect allows food to leak into the nose. It also causes the patient to be unable to speak correctly, producing a problematic nasal sound. Sometimes the first surgery does not completely correct the problem and a second surgery is needed. Looking at the records of patients who have had corrective surgeries done in the past would allow the surgeons to improve their success rate and reduce the need for secondary surgeries. It would also create greater patient safety and reduce cost for families.

NCT ID: NCT01252264 Completed - Cleft Palate Clinical Trials

FaceBase Biorepository

Start date: November 2010
Phase:
Study type: Observational

The purpose of this study is to find out if there are any genetic differences between people with and without disorders of the head, face, and eye. We will create a biorepository of samples from people with and without these types of birth defects. A biorepository is a collection or "bank" of human tissue materials (such as blood or saliva) for research purposes. These samples will then be available to investigators studying these disorders.

NCT ID: NCT00930124 Completed - Clinical trials for Cleft Lip and Palate

Cleft Orthognathic Surgery Versus Distraction Osteogenesis - Which is Better?

Start date: June 2002
Phase: Phase 2
Study type: Interventional

Cleft lip and palate patients normally present with a sunken face due to collapse in the middle part of the face and inability of the upper and lower teeth to meet during chewing. This situation constitutes a serious aesthetic and mastication problem. A single surgical operation known as orthognathic surgery was traditionally performed to move the upper jaw forward to a more normal position and allow chewing function to be regained. However, due to scar tissue from the original surgical repair of the cleft palate, this procedure is known to be unstable causing bone to rapidly go back to its original position. A new concept of moving the upper jaw bone gradually by 1mm per day using a special device attached to the bone called distraction osteogenesis was established in 1996. Animal studies have shown that this technique can produce stable results with minimal relapse. The feasibility of correcting cleft deformities by gradual distraction has been confirmed by our own clinical studies. The aim of this study (which is the first of its kind) is to conduct a prospective randomized controlled study and compare the treatment outcomes of the current standard (orthognathic surgery) with distraction osteogenesis (gradual bone movement). The objectives focus on four aspects: morbidity, stability, speech function and psychological impact. The results from this study will clarify several clinical dilemmas in decision making when choosing whether to use orthognathic surgery or distraction osteogenesis in the treatment of cleft lip and palate patients. In addition, it will also inform our multidisciplinary research team to improve the total care of the cleft lip and palate patients. Gradual bone distraction of the midface in cleft palate patients is more stable, less detrimental to speech, and no more troublesome to the patient than conventional osteotomy and bone transposition (orthognathic surgery).

NCT ID: NCT00829101 Completed - Cleft Palate Clinical Trials

Articulation and Phonology in Children With Unilateral Cleft Lip and Palate

APCLP
Start date: January 2009
Phase: N/A
Study type: Observational

The purpose of the study is to assess if there are any differences in the articulatory and phonological competence in pre-school children with unilateral cleft lip and palate (UCLP) who are treated with different surgical methods of palatal repair.

NCT ID: NCT00397917 Completed - Cleft Palate Clinical Trials

Oral Cleft Prevention Program

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.

NCT ID: NCT00340977 Completed - Cleft Palate Clinical Trials

Svangerskap, Arv, Og Miljo (Pregnancy, Heredity and Environment)

Start date: September 6, 1995
Phase:
Study type: Observational

This proposal describes a population-based case-control study of all Norwegian infants born with cleft lip or palate over a five-year period. The study will be jointly supported by the U.S. National Institute of Environmental Health Sciences (NIEHS), and the Norwegian National Institute of Public Health (SIFF) and Medical Birth Registry of Norway (MBR). Cases will be identified through the two surgery clinics that treat all clefts in Norway. Controls will be randomly selected from all live births through the MBR. Mothers will complete two selfadministered questionnaires; one regarding exposures before and during pregnancy, the other their diet during their early months of pregnancy. Biological specimens for DNA testing (blood samples, buccal swabs) will be collected from cases, controls and mothers in order to describe possible gene-environment interactions. With 750 cases and 1100 controls, this will be one of the largest and most complete field studies of facial clefting yet conducted.