NCT03259061

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

August 19, 2017

Last Update Submit

August 19, 2017

Conditions

Outcome Measures

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

    Baseline

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any

You may qualify if:

  • 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)

You may not qualify if:

  • Mental Retardation.
  • Presence of Neurological deficit affecting speech.
  • Palatal paralysis or paresis.
  • Overt cleft palate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    BACKGROUND
  • Skolnick ML, McCALL GN, Barnes M. The sphincteric mechanism of velopharyngeal closure. Cleft Palate J. 1973 Jul;10:286-305. No abstract available.

    PMID: 4513919BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 17366850BACKGROUND
  • 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.

    PMID: 16909536BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 17414269BACKGROUND
  • 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.

    PMID: 2758674BACKGROUND
  • 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.

    PMID: 1058753BACKGROUND
  • Simpson RK, Colton J. A cephalometric study of velar stretch in adolescent subjects. Cleft Palate J. 1980 Jan;17(1):40-7.

    PMID: 6928116BACKGROUND

MeSH Terms

Conditions

Velopharyngeal Insufficiency

Interventions

Cephalometry

Condition Hierarchy (Ancestors)

Mouth AbnormalitiesMouth DiseasesStomatognathic DiseasesPharyngeal DiseasesStomatognathic System AbnormalitiesOtorhinolaryngologic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AnthropometryPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Abdelazez Darwesh, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 19, 2017

First Posted

August 23, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2019

Study Completion

November 1, 2019

Last Updated

August 23, 2017

Record last verified: 2017-08