NCT05941416

Brief Summary

This study aims to evaluate orofacial myofunctional disorders among a group of children with bronchial asthma.

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
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 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

July 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

July 4, 2023

Last Update Submit

November 28, 2023

Conditions

Keywords

Orofacial myofunctional disordersBronchial AsthmaOMD

Outcome Measures

Primary Outcomes (1)

  • Orofacial myofunctional disorders

    Nordic orofacial test- screening

    Baseline

Secondary Outcomes (2)

  • Oral habits evaluation (Mouth Breathing only)

    Baseline

  • Oral Health-Related Quality of Life (OHRQoL)

    Baseline

Interventions

Nordic Orofacial Test- screening is an instrument that can be used for the identification of orofacial myofunctional disorders in children aged three years or older, in youths and in adults. It is divided into two sections, interview and examination. The screening can be directed by dental or health care professional personnel.

Also known as: Child perceptions questionnaire for 8-10-year-old children

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Egyptian children with bronchial asthma aged between 8-10 years old

You may qualify if:

  • Children aged between 8-10 years old
  • Asthmatic children were selected from the Asthma and Allergy Outpatients Clinic of Abu El-Reesh Japanese Hospital for kids

You may not qualify if:

  • Children who refused to participate
  • Children with Cognitive problems
  • Children with neurological diseases
  • Children undergoing orthodontic treatment
  • Children who underwent speech therapy
  • Children who underwent otorhinolaryngology surgery
  • Children with a history of oral habits such as thumb sucking, pacifier use, bottle, and nail-biting, over the age of three years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Al-Blaihed D, El-Housseiny AA, Farsi NJ, Farsi NM. Validity and reliability of the Arabic version of the child perceptions questionnaire for 8-10-year-old children. Qual Life Res. 2020 Nov;29(11):3131-3141. doi: 10.1007/s11136-020-02545-y. Epub 2020 Jun 10.

    PMID: 32524347BACKGROUND
  • Araujo BCL, Lima TRCM, de Gois-Santos VT, Nascimento GKBO, Martins-Filho PR, Simoes SM. Association between nasal patency and orofacial myofunctional changes in patients with asthma and rhinitis. Eur Arch Otorhinolaryngol. 2021 Jul;278(7):2371-2377. doi: 10.1007/s00405-020-06518-2. Epub 2021 Jan 2.

    PMID: 33389007BACKGROUND
  • Bakke M, Bergendal B, McAllister A, Sjogreen L, Asten P. Development and evaluation of a comprehensive screening for orofacial dysfunction. Swed Dent J. 2007;31(2):75-84.

    PMID: 17695052BACKGROUND
  • Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, Brignardello-Petersen R, Canonica GW, Casale T, Chavannes NH, Correia de Sousa J, Cruz AA, Cuello-Garcia CA, Demoly P, Dykewicz M, Etxeandia-Ikobaltzeta I, Florez ID, Fokkens W, Fonseca J, Hellings PW, Klimek L, Kowalski S, Kuna P, Laisaar KT, Larenas-Linnemann DE, Lodrup Carlsen KC, Manning PJ, Meltzer E, Mullol J, Muraro A, O'Hehir R, Ohta K, Panzner P, Papadopoulos N, Park HS, Passalacqua G, Pawankar R, Price D, Riva JJ, Roldan Y, Ryan D, Sadeghirad B, Samolinski B, Schmid-Grendelmeier P, Sheikh A, Togias A, Valero A, Valiulis A, Valovirta E, Ventresca M, Wallace D, Waserman S, Wickman M, Wiercioch W, Yepes-Nunez JJ, Zhang L, Zhang Y, Zidarn M, Zuberbier T, Schunemann HJ. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol. 2017 Oct;140(4):950-958. doi: 10.1016/j.jaci.2017.03.050. Epub 2017 Jun 8.

    PMID: 28602936BACKGROUND
  • Castro MS, Toro AA, Sakano E, Ribeiro JD. Evaluation of oral functions of the stomatognathic system according to the levels of asthma severity. J Soc Bras Fonoaudiol. 2012;24(2):119-24. doi: 10.1590/s2179-64912012000200005. English, Portuguese.

    PMID: 22832677BACKGROUND
  • D'Onofrio L. Oral dysfunction as a cause of malocclusion. Orthod Craniofac Res. 2019 May;22 Suppl 1(Suppl 1):43-48. doi: 10.1111/ocr.12277.

    PMID: 31074141BACKGROUND
  • De Menezes VA, Leal RB, Pessoa RS, Pontes RM. Prevalence and factors related to mouth breathing in school children at the Santo Amaro project-Recife, 2005. Braz J Otorhinolaryngol. 2006 May-Jun;72(3):394-9. doi: 10.1016/s1808-8694(15)30975-7.

    PMID: 17119778BACKGROUND
  • Carvalho-Oliveira M, Salles C, Terse R, D'Oliveira A Junior. Association between severe asthma and changes in the stomatognathic system. J Bras Pneumol. 2016 Nov-Dec;42(6):423-428. doi: 10.1590/S1806-37562015000600006.

    PMID: 28117472BACKGROUND
  • Garcia-Marcos L, Asher MI, Pearce N, Ellwood E, Bissell K, Chiang CY, El Sony A, Ellwood P, Marks GB, Mortimer K, Martinez-Torres AE, Morales E, Perez-Fernandez V, Robertson S, Rutter CE, Silverwood RJ, Strachan DP; Global Asthma Network Phase I Study Group. The burden of asthma, hay fever and eczema in children in 25 countries: GAN Phase I study. Eur Respir J. 2022 Sep 15;60(3):2102866. doi: 10.1183/13993003.02866-2021. Print 2022 Sep.

    PMID: 35144987BACKGROUND
  • Georgy V, Fahim HI, El-Gaafary M, Walters S. Prevalence and socioeconomic associations of asthma and allergic rhinitis in northern [corrected] Africa. Eur Respir J. 2006 Oct;28(4):756-62. doi: 10.1183/09031936.06.00089005. Epub 2006 May 31.

    PMID: 16737986BACKGROUND
  • Koshak EA. Classification of asthma according to revised 2006 GINA: evolution from severity to control. Ann Thorac Med. 2007 Apr;2(2):45-6. doi: 10.4103/1817-1737.32228. No abstract available.

    PMID: 19727344BACKGROUND
  • de Felicio CM, Melchior Mde O, Ferreira CL, Da Silva MA. Otologic symptoms of temporomandibular disorder and effect of orofacial myofunctional therapy. Cranio. 2008 Apr;26(2):118-25. doi: 10.1179/crn.2008.016.

    PMID: 18468271BACKGROUND
  • Milanesi JM, Berwig LC, Marquezan M, Schuch LH, Moraes AB, Silva AMTD, Correa ECR. Variables associated with mouth breathing diagnosis in children based on a multidisciplinary assessment. Codas. 2018 Mar 19;30(4):e20170071. doi: 10.1590/2317-1782/20182017071.

    PMID: 29561967BACKGROUND
  • Ukena D, Fishman L, Niebling WB. Bronchial asthma: diagnosis and long-term treatment in adults. Dtsch Arztebl Int. 2008 May;105(21):385-94. doi: 10.3238/arztebl.2008.0385. Epub 2008 May 23.

    PMID: 19626179BACKGROUND
  • YILMAZ BC, Alaçam A. Evaluation of orofacial dysfunctions and oral health-related quality of life in children with asthma. Acta Odontologica Turcica. 2023 Jan 1;40(1):22-8.

    BACKGROUND
  • Leme MS, Barbosa TD, Gavião MB. Assessment of orofacial functions in Brazilian children using the Nordic Orofacial Test-Screening (NOT-S). Revista Odonto Ciência. 2012;27:108-14.

    BACKGROUND
  • Cerci Neto A, Kohatsu M, Moreira AC. Programa Respira Londrina. Cerci Neto, A. organizador. Asma em Saúde Pública. São Paulo: Manole. 2007:79-92.

    BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Manal A Elsayed, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 12, 2023

Study Start

February 1, 2024

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

December 1, 2023

Record last verified: 2023-11