ClinicalTrials.gg
Status unknownNCT03259061Updated Aug 23, 2017

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

An observational study in Velopharyngeal Insufficiency, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2017-08-23.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Velopharyngeal Insufficiency
03

In context

Velopharyngeal Insufficiency

20 studies on the registry are indexed under Velopharyngeal Insufficiency; 9 are open to participants now.

Browse Velopharyngeal Insufficiency studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Any

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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

Exclusion criteria

Exclusion Criteria:

  1. Mental Retardation.
  2. Presence of Neurological deficit affecting speech.
  3. Palatal paralysis or paresis.
  4. Overt cleft palate.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • DeviceFlexible 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

    Also known as: Cephalometry

06

What researchers measure

Primary outcomes

  1. Comparison between Cephalometric and nasofibroscopic findings and clinical findings

    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

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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.
  • Skolnick ML, McCALL GN, Barnes M. The sphincteric mechanism of velopharyngeal closure. Cleft Palate J. 1973 Jul;10:286-305. No abstract available. PubMed 4513919 ↗
  • 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.
  • De Bodt M, Van Lierde K. Cleft palate speech and velopharyngeal dysfunction: the approach of the speech therapist. B-ENT. 2006;2 Suppl 4:63-70. PubMed 17366850 ↗
  • Trindade IE, Genaro KF, Yamashita RP, Miguel HC, Fukushiro AP. [Proposal for velopharyngeal function rating in a speech perceptual assessment]. Pro Fono. 2005 May-Aug;17(2):259-62. doi: 10.1590/s0104-56872005000200015. Portuguese. PubMed 16909536 ↗
  • 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.
  • Smith BE, Kuehn DP. Speech evaluation of velopharyngeal dysfunction. J Craniofac Surg. 2007 Mar;18(2):251-61; quiz 266-7. doi: 10.1097/SCS.0b013e31803ecf3b. PubMed 17414269 ↗
  • D'Antonio LL, Marsh JL, Province MA, Muntz HR, Phillips CJ. Reliability of flexible fiberoptic nasopharyngoscopy for evaluation of velopharyngeal function in a clinical population. Cleft Palate J. 1989 Jul;26(3):217-25; discussion 225. PubMed 2758674 ↗
  • Mourino AP, Weinberg B. A cephalometric study of velar stretch in 8 and 10-year old children. Cleft Palate J. 1975 Oct;12:417-35. PubMed 1058753 ↗
  • Simpson RK, Colton J. A cephalometric study of velar stretch in adolescent subjects. Cleft Palate J. 1980 Jan;17(1):40-7. PubMed 6928116 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2017; primary completion for Sep 2019, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2017
First posted
Aug 23, 2017
StartEst.
Sep 1, 2017
Primary completionEst.
Sep 2019
CompletionEst.
Nov 2019
Last update
Aug 23, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03259061
Lead sponsor
Assiut University
Responsible party
AbdElAzeez Mohammad Faheem Darweesh (Dr, Assiut University) — Principal investigator
First posted
Aug 23, 2017
Start date
Sep 1, 2017 (estimated)
Primary completion
Sep 2019 (estimated)
Completion
Nov 2019 (estimated)
Last update
Aug 23, 2017

Study contacts

Abdelazez Darwesh, doctor
Contact
dr.abdelazez.darwesh@gmail.com
+201002600619

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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