Orofacial Myofunctional DisordersNCT05941416
Orofacial Myofunctional Disorder Among Asthmatic Children
An observational study of Orofacial Myofunctional Disorders, run by Cairo University.
Trial summary
This study aims to evaluate orofacial myofunctional disorders among a group of children with bronchial asthma. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Orofacial Myofunctional Disorders
- What is being tested?
- Nordic Orofacial test- screening arabic modified version
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Child
Study population: Egyptian children with bronchial asthma aged between 8-10 years old
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation Of Orofacial Myofunctional Disorders Among A Group Of Children With Bronchial Asthma: A Cross-Sectional (Observational) Study
This study aims to evaluate orofacial myofunctional disorders among a group of children with bronchial asthma.
Read the 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.
- Conditions
- Orofacial Myofunctional Disorders
- Being tested
- Nordic Orofacial test- screening arabic modified version
- Keywords
- Orofacial myofunctional disorders, Bronchial Asthma, OMD
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic Orofacial test- screening arabic modified versionDiagnostic test
Also called Child perceptions questionnaire for 8-10-year-old children
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Orofacial myofunctional disorders
Nordic orofacial test- screening
Measured: Baseline
Secondary outcomes (2)
Oral habits evaluation (Mouth Breathing only)
Massler's water-holding test
Measured: Baseline
Oral Health-Related Quality of Life (OHRQoL)
Children perceptions questionnaire for 8-10-year-old children arabic version (CPQ8-10)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study startFeb 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Orofacial Myofunctional DisordersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yara mamdouh khalifa ahmed, Cairo University
- Investigators
- Manal A Elsayed, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941416
- Sponsor's protocol ID
- OMD in Asthmatic
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32524347Araujo 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.
PubMed 33389007Bakke 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.
PubMed 17695052Brozek 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.
PubMed 28602936Castro 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.
PubMed 22832677D'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.
PubMed 31074141De 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.
PubMed 17119778Carvalho-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.
PubMed 28117472Garcia-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.
PubMed 35144987Georgy 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.
PubMed 16737986Koshak 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.
PubMed 19727344de 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.
PubMed 18468271Milanesi 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.
PubMed 29561967Ukena 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.
PubMed 19626179YILMAZ 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Orofacial Myofunctional Disorders Among A Group Of Children With Bronchial Asthma: A Cross-Sectional (Observational) Study
- ClinicalTrials.gov ID
- NCT05941416
- Acronym / sponsor ID
- OMD in Asthmatic
- Conditions
- Orofacial Myofunctional Disorders
- Keywords
- Orofacial myofunctional disorders, Bronchial Asthma, OMD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate orofacial myofunctional disorders among a group of children with bronchial asthma.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- Egyptian children with bronchial asthma aged between 8-10 years old
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Children who refused to participate
- Children with Cognitive problems
- Children with neurological diseases
- Children undergoing orthodontic treatment
- Children who underwent speech therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic Orofacial test- screening arabic modified versionAlso: Child perceptions questionnaire for 8-10-year-old childrenNordic 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. | Diagnostic test | – |
Primary outcome
Orofacial myofunctional disorders
Time frame: Baseline
Nordic orofacial test- screening
2 secondary outcomes
Oral habits evaluation (Mouth Breathing only)
Time frame: Baseline
Oral Health-Related Quality of Life (OHRQoL)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 32524347Al-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.
- Background: PubMed 33389007Araujo 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.
- Background: PubMed 17695052Bakke 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.
- Background: PubMed 28602936Brozek 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.
- Background: PubMed 22832677Castro 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.
- Background: PubMed 31074141D'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.
- Background: PubMed 17119778De 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.
- Background: PubMed 28117472Carvalho-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.
- Background: PubMed 35144987Garcia-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.
- Background: PubMed 16737986Georgy 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.
- Background: PubMed 19727344Koshak 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.
- Background: PubMed 18468271de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal A Elsayed, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Orofacial Myofunctional Disorders, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yara M Ahmed, Master (+201008521297, Yara.khalifa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orofacial myofunctional disorders (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941416, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.