Trial record 1 of 6 for:    "Velopharyngeal Insufficiency"
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A Study of Border Line Cases of Velopharyngeal Incompetence Using Cephalometry and Nasofibroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03259061
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Information provided by (Responsible Party):
AbdElAzeez Mohammad Faheem Darweesh, Assiut University

Brief Summary:
The aim of this work is to evaluate the role of cephalometry &nasofibroscopy as objective tools in order to confirm the diagnosis based upon the clinical judgment of border line cases suspected to have velopharyngeal incompetence or insufficiency.

Condition or disease Intervention/treatment
Velopharyngeal Insufficiency Device: Flexible fiberoptic nasopharyngoscopy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Border Line Cases of Velopharyngeal Incompetence and Insufficiency Using Cephalometry and Nasofibroscopy
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Flexible fiberoptic nasopharyngoscopy
    1. Flexible fiberoptic nasopharyngoscopy (FFN) allows direct transnasal observation of the anatomy and dynamic activity of the velopharyngeal sphincter. Such observations can be recorded for permanent documentation by coupling FFN to a video camera with simultaneous audio recording. Numerous published reports discuss the advantages of FFN as a clinical method for evaluating velopharyngeal function during speech (10).
    2. Cephalometric analysis, is the clinical application of cephalometry. It is analysis of the dental and skeletal relationships of a human skull and is frequently used by dentists, orthodontists, and oral and maxillofacial surgeons as a treatment planning tool.

    Cephalometric analysis can also be applied for assessing the velopharyngeal structure and function. More specifically, velopharyngeal function in terms of its shape and mobility was analyzed quantitatively on the basis of cephalometric principle

    Other Name: Cephalometry

Primary Outcome Measures :
  1. Comparison between Cephalometric and nasofibroscopic findings and clinical findings [ Time Frame: Baseline ]
    Assessment of the function of velopharyngeal valve by nasofibroscopy and cephalometric measurements in clinically border line cases of velopharyngeal incompetence in order to ensure the presence of Velophayngeal incompetence

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

Patients must have border line velopharyngeal abnormality which was diagnosed clinically.

Ability to understand and the willingness to sign a written informed consent(if he was a child so his parents or his guardian should has tis ability)

Exclusion Criteria:

  1. Mental Retardation.
  2. Presence of Neurological deficit affecting speech.
  3. Palatal paralysis or paresis.
  4. Overt cleft palate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03259061

Contact: Abdelazez Darwesh, doctor +201002600619

Sponsors and Collaborators
Assiut University

Camargo LO, Rodrigues CM, Avelar JA. Oclusão velofaríngea em indivíduos submetidos à nasoendoscopia na Clínica de Educação para Saúde (CEPS) 20(1):35-48, 2001.
Penido FA, Noronha RM, Caetano KI, Jesus MS, Di Ninno CQ, Britto AT. Correlação entre os achados do teste de emissão de ar nasal e da nasofaringoscopia em pacientes com fissura labiopalatina operada. Rev Soc Bras Fonoaudiol. 2007;12(2):126-34.
Mourão D, Souza GS, Torres LV, Vaz RN, Prado SG. Estudo sobre desenvolvimento fonológico em fissurados: implicações na fala e na linguagem. Estudos. 2006;33(5/6):425-41.
Witt PD. Management of velopharyngeal dysfunction. In: Persing JA, Evans GR. Soft-tissue surgery of the craniofacial region. New York: Informa; 2007. p.113-28.

Responsible Party: AbdElAzeez Mohammad Faheem Darweesh, Dr, Assiut University Identifier: NCT03259061     History of Changes
Other Study ID Numbers: Border line VPI study
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Velopharyngeal Insufficiency
Mouth Abnormalities
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Diseases
Stomatognathic System Abnormalities
Otorhinolaryngologic Diseases
Congenital Abnormalities