A Study of Border Line Cases of Velopharyngeal Incompetence Using Cephalometry and Nasofibroscopy

August 19, 2017 updated by: AbdElAzeez Mohammad Faheem Darweesh, Assiut University

A Study of Border Line Cases of Velopharyngeal Incompetence and Insufficiency Using Cephalometry and Nasofibroscopy

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.

Study Overview

Status

Unknown

Detailed Description

The velopharyngeal mechanism is constituted by the muscles of the soft palate, posterior and lateral pharyngeal walls (1), separating the oropharynx from the nasopharynx. Such structures, particularly the soft palate, play a key role in the velopharyngeal closure physiology (2). Velopharyngeal closure patterns may be classified as follows: coronal, where there is predominant soft palate movement toward the posterior pharyngeal wall; sagittal, where there is predominant movement of the lateral pharyngeal walls toward the pharynx midline; circular, where balanced movements of lateral pharyngeal walls and soft palate are observed; circular with Passavant's ridge, where the circular closure is associated with the development of a mucosal fold named Passavant's ridge on the posterior pharyngeal wall(3). The velopharyngeal closure allows the separation between the nasal and oral cavities during activities such as oral sounds emission, blowing, whistling, swallowing, sucking and vomiting reflex, respecting the level of closure demanded by each activity (4,5).

In cases where the structures of the velopharyngeal mechanism do not work properly, the presence of a space called velopharyngeal aperture is observed between them, characterizing a velopharyngeal dysfunction. One of the reasons for the occurrence of such an aperture is the shortage of soft palate tissue. This dysfunction is called velopharyngeal insufficiency and may be corrected either surgically or by prosthetic management followed by speech therapy. In cases where such dysfunction occurs because of a failure in the velopharyngeal structures movement, physiological or neuromotor deficiency, it is called velopharyngeal incompetence that may be eliminated by means of speech therapy (2,6). On the other hand, if such condition is a result of the presence of compensatory articulations or other speech learning errors, it does not reflect physical or neuromuscular alterations, constituting indication for speech therapy(7). Individuals with velopharyngeal dysfunction present hypernasality, nasal air emission, poor intraoral pressure, and may present associated nasal/facial movements and compensatory articulations during the emission of oral consonants (8,9).

Assessment of the velopharyngeal function can be done by the following procedures:

  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).

    Flexible fiberoptic nasopharyngoscopy (FFN) is a valuable tool for direct visualization because it allows observation of the velopharyngeal valve during dynamic activity for a prolonged period with (1) Minimal interference of the structures involved and (2) No radiation exposure. Whereas most clinicians acknowledge the theoretic advantages of FFN and accept it as a valid technique for assessing velopharyngeal function, there are few published studies that have addressed the validity and reliability of endoscopic procedures (10). Endoscopic evaluation has high face validity, and several reports have indicated that FFN has good construct validity when compared with radiologic assessments (11).

  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 (12,13).

Border line cases of velopharyngeal incompetence of insufficiency are known to be problematic and usually causes confusion for phoniatricians especially in patients who will undergo adenotonsillectomy. For this purpose, objective assessment is necessary to support or reject the clinical findings of VPI cases.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

August 19, 2017

First Submitted That Met QC Criteria

August 19, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 19, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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