Prevalence of Tongue Anomalies in Egyptian Children | NCT05779618

Studies
Prevalence of Tongue Anomalies in Egyptian Children

NCT05779618

Sponsor

Cairo University

Status

Completed

Last Update Posted

Oct 17, 2023Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Tongue; Anomaly

Interventions

no intervention

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2023Actual

Primary Completion Date

Jun 1, 2023Actual

Completion Date

Aug 10, 2023Actual

First Submitted Date

Mar 8, 2023

First Submission Date that Met QC Criteria

Mar 20, 2023

First Posted Date

Mar 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2023

Last Update Posted Date

Oct 17, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aya Mostafa Mohamed Elzahaby, Principle investigator, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	observational study, all data collected are binary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of tongue anomalies	studying the prevalence of tongue anomalies among Egyptian children between 6 to 12 years old	1 month

Secondary Outcomes

Measure	Description	Time Frame
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)	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with history of significant medical conditions
Participants undertaken anti-fungal drugs in the previous 12 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

school children between six to twelve years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Randa Abd Al Gawad, Dental PhD	Cairo University	Study Director
Yasmin Yousry, Dental PhD	Cairo University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aley Ibn Abi Taleb primary school		Cairo			Egypt
Mansheyet Gebril primary school

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16264385	Background	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.
19656020	Background	Suter 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.

ID	Term
D000013	Congenital Abnormalities
D000072676	Ankyloglossia
D014063	Tongue, Fissured
D005929	Glossitis, Benign Migratory
D008260	Macroglossia

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D009057	Stomatognathic Diseases
D014060	Tongue Diseases
D009059	Mouth Diseases