Tongue; AnomalyNCT05779618
Prevalence of Tongue Anomalies in Egyptian Children
An observational study of Tongue; Anomaly, run by Cairo University at 2 sites in Egypt.
Trial summary
The purpose of the study is to determine the prevalence of tongue anomalies in a group of Egyptian children and to relate the presence of malocclusion in cases of macroglossia, tongue tie and microglossia. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tongue; Anomaly
- How many people
- 250 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Mar 2023to 10 Aug 2023
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: school children between six to twelve years old
Who may be able to join
- Participants' age between 6-12 years.
- Co-operative child
- Positive participants' acceptance for participation in the study.
- Participants having responsible care giver answered by approval on the previously sent informed consent which describes the aim \& importance of the study
Who cannot join
- Patients with history of significant medical conditions
- Participants undertaken anti-fungal drugs in the previous 12 months
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Aley Ibn Abi Taleb primary school
Cairo
Mansheyet Gebril primary school
Cairo
About this study
Official title: Prevalence of Tongue Anomalies Among Group of Egyptian Children: a Cross-sectional Study
The purpose of the study is to determine the prevalence of tongue anomalies in a group of Egyptian children and to relate the presence of malocclusion in cases of macroglossia, tongue tie and microglossia.
Read the detailed description
The tongue is an important and accessible muscle in the oral cavity, it has many functions which includes speech, chewing, swallowing, sucking, control of breathing, growth and developments of the jaws and perception to pain.
Also, many systemic disorders and diseases affect the tongue which makes it a great reflector of the general health.
Tongue anomalies has different frequencies and prevalence between different countries, these differences may be due to geographic, ethnic, gender and age variability, for example a study in Iran in 2003 found that the prevalence of tongue anomalies 34.3%, while another study in Colombia in 2013 found that the prevalence of tongue anomalies on their study population was 79.9%.
The knowledge of the prevalence of tongue anomalies among Egyptian children is missing in the literature which could compromise the quality of dental care, increase the occurrence of orthodontic problems and decrease the chances of early detection of some systemic diseases, since tongue anomalies could help in early determination of some systemic diseases in cases of fissured tongue and geographic tongue as well as early prevention and early intervention of malocclusions and speech defects that might be caused in cases of microglossia, macroglossia and ankyloglossia.
Hence, the knowledge of prevalence of tongue anomalies among Egyptian children can aid in setting a reference which will then help in public health planning and prevention policies.
- Conditions
- Tongue; Anomaly
- Being tested
- no intervention
- Keywords
- Tongue anomalies, ankyloglossia, Fissured tongue, Geographic tongue, macroglossia
- Medical subject headings
- Congenital Abnormalities, Ankyloglossia, Tongue, Fissured, Glossitis, Benign Migratory, Macroglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational study, all data collected are binary
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of tongue anomalies
studying the prevalence of tongue anomalies among Egyptian children between 6 to 12 years old
Measured: 1 month
Secondary outcomes (1)
macroglossia, microglossia and ankyloglossia effect on occlusion
detecting the presence or absence of malocclusion in cases of three types of tongue anomalies (ankyloglossia, macroglossia and microglossia)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start25 Mar 2023
- Primary completion1 Jun 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tongue; AnomalyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mostafa Mohamed Elzahaby, Cairo University
- Investigators
- Randa Abd Al Gawad, Dental PhD, Study director, Cairo UniversityYasmin Yousry, Dental PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779618
- Sponsor's protocol ID
- 120805
- Status last verified
- Oct 2023
- First submitted
- 8 Mar 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared via email to other researchers if needed.
Publications
Rioboo-Crespo Mdel R, Planells-del Pozo P, Rioboo-Garcia R. Epidemiology of the most common oral mucosal diseases in children. Med Oral Patol Oral Cir Bucal. 2005 Nov-Dec;10(5):376-87. English, Spanish.
PubMed 16264385Suter VG, Bornstein MM. Ankyloglossia: facts and myths in diagnosis and treatment. J Periodontol. 2009 Aug;80(8):1204-19. doi: 10.1902/jop.2009.090086.
PubMed 19656020Belmehdi A, Harti KE, Wady WE. Ankyloglossia as an oral functional problem and its surgical management. Dent Med Probl. 2018 Apr-Jun;55(2):213-216. doi: 10.17219/dmp/85708.
PubMed 30152627Avcu N, Kanli A. The prevalence of tongue lesions in 5150 Turkish dental outpatients. Oral Dis. 2003 Jul;9(4):188-95. doi: 10.1034/j.1601-0825.2003.02933.x.
PubMed 12974518Chang PS, Yen TH, Huang CJ, Yen AM, Chen SL, Tsai AI. Clinical Orodental Anomalies in Taiwanese Children under Age Six: a Study Based on the 1995-1997 National Dental Survey. Biomed Res Int. 2020 Jul 19;2020:2056340. doi: 10.1155/2020/2056340. eCollection 2020.
PubMed 32766305Rezaei F, Safarzadeh M, Mozafari H, Tavakoli P. Prevalence of Geographic tongue and Related Predisposing Factors in 7-18 Year-Old Students in Kermanshah, Iran 2014. Glob J Health Sci. 2015 Feb 24;7(5):91-5. doi: 10.5539/gjhs.v7n5p91.
PubMed 26156909
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Tongue Anomalies Among Group of Egyptian Children: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05779618
- Acronym / sponsor ID
- 120805
- Conditions
- Tongue; Anomaly
- Keywords
- Tongue anomalies, ankyloglossia, Fissured tongue, Geographic tongue, macroglossia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 22 Mar 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.
The purpose of the study is to determine the prevalence of tongue anomalies in a group of Egyptian children and to relate the presence of malocclusion in cases of macroglossia, tongue tie and microglossia.
Detailed description
The tongue is an important and accessible muscle in the oral cavity, it has many functions which includes speech, chewing, swallowing, sucking, control of breathing, growth and developments of the jaws and perception to pain.
Also, many systemic disorders and diseases affect the tongue which makes it a great reflector of the general health.
Tongue anomalies has different frequencies and prevalence between different countries, these differences may be due to geographic, ethnic, gender and age variability, for example a study in Iran in 2003 found that the prevalence of tongue anomalies 34.3%, while another study in Colombia in 2013 found that the prevalence of tongue anomalies on their study population was 79.9%.
The knowledge of the prevalence of tongue anomalies among Egyptian children is missing in the literature which could compromise the quality of dental care, increase the occurrence of orthodontic problems and decrease the chances of early detection of some systemic diseases, since tongue anomalies could help in early determination of some systemic diseases in cases of fissured tongue and geographic tongue as well as early prevention and early intervention of malocclusions and speech defects that might be caused in cases of microglossia, macroglossia and ankyloglossia.
Hence, the knowledge of prevalence of tongue anomalies among Egyptian children can aid in setting a reference which will then help in public health planning and prevention policies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- school children between six to twelve years old
Key inclusion criteria (4 listed)
- Participants' age between 6-12 years.
- Co-operative child
- Positive participants' acceptance for participation in the study.
- Participants having responsible care giver answered by approval on the previously sent informed consent which describes the aim \& importance of the study
Key exclusion criteria (2 listed)
- Patients with history of significant medical conditions
- Participants undertaken anti-fungal drugs in the previous 12 months
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 |
|---|---|---|
| no interventionobservational study, all data collected are binary | Other | – |
Primary outcome
prevalence of tongue anomalies
Time frame: 1 month
studying the prevalence of tongue anomalies among Egyptian children between 6 to 12 years old
1 secondary outcome
macroglossia, microglossia and ankyloglossia effect on occlusion
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 16264385Rioboo-Crespo Mdel R, Planells-del Pozo P, Rioboo-Garcia R. Epidemiology of the most common oral mucosal diseases in children. Med Oral Patol Oral Cir Bucal. 2005 Nov-Dec;10(5):376-87. English, Spanish.
- Background: PubMed 19656020Suter VG, Bornstein MM. Ankyloglossia: facts and myths in diagnosis and treatment. J Periodontol. 2009 Aug;80(8):1204-19. doi: 10.1902/jop.2009.090086.
- Background: PubMed 30152627Belmehdi A, Harti KE, Wady WE. Ankyloglossia as an oral functional problem and its surgical management. Dent Med Probl. 2018 Apr-Jun;55(2):213-216. doi: 10.17219/dmp/85708.
- Background: PubMed 12974518Avcu N, Kanli A. The prevalence of tongue lesions in 5150 Turkish dental outpatients. Oral Dis. 2003 Jul;9(4):188-95. doi: 10.1034/j.1601-0825.2003.02933.x.
- Background: PubMed 32766305Chang PS, Yen TH, Huang CJ, Yen AM, Chen SL, Tsai AI. Clinical Orodental Anomalies in Taiwanese Children under Age Six: a Study Based on the 1995-1997 National Dental Survey. Biomed Res Int. 2020 Jul 19;2020:2056340. doi: 10.1155/2020/2056340. eCollection 2020.
- Background: PubMed 26156909Rezaei F, Safarzadeh M, Mozafari H, Tavakoli P. Prevalence of Geographic tongue and Related Predisposing Factors in 7-18 Year-Old Students in Kermanshah, Iran 2014. Glob J Health Sci. 2015 Feb 24;7(5):91-5. doi: 10.5539/gjhs.v7n5p91.
- Individual participant dataSharing planned: Yes. Data to be shared via email to other researchers if needed.
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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.
Randa Abd Al Gawad, Dental PhD study director
Cairo University
Yasmin Yousry, Dental PhD study chair
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tongue; Anomaly, run by Cairo University at 2 sites in Egypt.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of tongue anomalies (time frame: 1 month). 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 NCT05779618, which also lists 6 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 17 Oct 2023.