Nordic Orofacial test- screening arabic modified version in Orofacial Myofunctional Disorders - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Orofacial Myofunctional Disorders

Intervention / Treatment

Diagnostic test: Nordic Orofacial test- screening arabic modified version

Detailed Description

Scientific Background (Statement of the problem):

Bronchial Asthma is a growing prevalent health problem among pediatric patients. The prevalence of Bronchial Asthma among children and adolescence in Cairo, Egypt was 9.4%. It is a chronic inflammatory disease that affects the lungs characterized by bronchial hyperactivity causing reversible airway obstruction and inflammation, and increased airway receptivity to stimuli. Bronchial Asthma classification, historically, depended on the severity of symptoms, but recently Bronchial Asthma was classified according to levels of control: controlled, partly controlled, or uncontrolled. That recent classification considers not only the disease's severity but also the responsiveness to medications.

As a result of inflammatory response and airway obstruction, difficulty in breathing may cause discomfort to the patients. So oral breathing become an alternative to nasal breathing. This change in the way of breathing can affect craniofacial growth which in sequence affects facial muscles.

The most characteristic features of mouth breathing are a long face, flat nose with narrow nostrils, hypotonic orofacial muscles, and open or semi-open mouth. Early diagnosis of mouth breathing can prevent the development of these features.

The stomatognathic system is a functional complex with a highly adaptable complex of bones, muscles, joints, teeth, lips, tongue, cheeks, glands, arteries, veins, and nerves that act harmoniously. So, any change in this harmony causes imbalance and alteration in the function which is called Orofacial Myofunctional Disorders.

Orofacial Myofunctional Disorders are multifactorial conditions common in many genetic and congenital disorders. As well it can be acquired as a result of mouth breathing, deviate swallowing, TMD, trauma, tongue thrusting, sucking, or chewing habits past the age of 3. Orofacial Myofunctional can be severely disabling as it affects chewing, swallowing, speech, facial expression, appearance and in conclusion affects oral health-related quality of life in children (OHRQoL).

Symptoms of Orofacial Myofunctional Disorders may include facial asymmetry, mouth breathing, tongue thrusting, impaired speech, malocclusion, improper jaw growth, facial pain, drooling, dry mouth and sleeping disorder.

Nordic Orofacial Test- screening (NOT-S) is a comprehensive screening instrument for the assessment of orofacial dysfunction. Nordic Orofacial Test- screening was first reported at the Second Nordic Conference on Orofacial Therapy in Gothenburg in 2002. Nordic Orofacial Test- screening has good reliability and gives a rough discrimination between normal orofacial function and various degrees of orofacial disability.

Oral Health-Related Quality of Life in children (OHRQoL) is determined by social interactions, including speech, emotional communication, facial expression, and appearance. It can be measured by Child Perceptions Questionnaire (CPQ8-10).

This study aims to evaluate orofacial myofunctional disorders among a group of children with Bronchial Asthms

Review of Literature:

Bronchial Asthma is a chronic inflammatory disease that targets millions of children and adolescence on an international scale. In 2006 was reported that the prevalence of Bronchial Asthma was 9.4% among school children and adolescence in Cairo, Egypt. According to the World Health Organization WHO, in 2005, the cost of asthma medication exceeded the cost of AIDS. In 2022, The recent Global Asthma Study (GAN) phase reported that worldwide prevalence of asthma among children reached 11% at age 6-7 years and 9.1 at age 13-14 years.

Bronchial asthma is a lower respiratory tract infection that causes narrowing in bronchial tubes and airway obstruction. It was founded that as a result to airway obstruction, asthmatic patients choose oral breathing as an alternative to nasal breathing.

An association was found between asthma onset and Orofacial Myofunctional Disorders observed in adults. In this study the authors reported that Orofacial Myofunctional Disorders are often observed in asthmatic patients that got affected by the disease before the age of 14. It was also reported that Orofacial Myofunctional Disorders and Malocclusion were found more among asthmatic children and adolescence when compared to healthy children. These children showed inadequate positioning of the jaw and during swallowing of water, tension in the facial muscles was reported Then it was verified that Orofacial Myofunctional Disorders were statistically higher in the asthma group. The highest facial disfunctions had been found were chewing and swallowing food with certain consistency and long mealtime more than 30 minutes. These results affected the Oral Health Quality of Life for the asthmatic patients.

Study Type

Observational

Enrollment (Estimated)

195

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

Name: Yara M Ahmed, Master
Phone Number: +201008521297
Email: Yara.khalifa@dentistry.cu.edu.eg

Study Contact Backup

Name: Shereen H Ehshamy, Lecturer
Phone Number: +201062978423
Email: Shereen.hassan@dentistry.cu.edu.eg

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

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orofacial myofunctional disorders Time Frame: Baseline	Nordic orofacial test- screening	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral habits evaluation (Mouth Breathing only) Time Frame: Baseline	Massler's water-holding test	Baseline
Oral Health-Related Quality of Life (OHRQoL) Time Frame: Baseline	Children perceptions questionnaire for 8-10-year-old children arabic version (CPQ8-10)	Baseline

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

Study Director: Manal A Elsayed, Professor, Cairo University

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria