NCT05779618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

March 8, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

March 8, 2023

Last Update Submit

October 15, 2023

Conditions

Keywords

Tongue anomaliesankyloglossiaFissured tongueGeographic tonguemacroglossia

Outcome Measures

Primary Outcomes (1)

  • prevalence of tongue anomalies

    studying the prevalence of tongue anomalies among Egyptian children between 6 to 12 years old

    1 month

Secondary Outcomes (1)

  • macroglossia, microglossia and ankyloglossia effect on occlusion

    1 month

Interventions

observational study, all data collected are binary

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

school children between six to twelve years old

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aley Ibn Abi Taleb primary school

Cairo, Egypt

Location

Mansheyet Gebril primary school

Cairo, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 16264385BACKGROUND
  • 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.

    PMID: 19656020BACKGROUND
  • Belmehdi 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.

    PMID: 30152627BACKGROUND
  • Avcu 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.

    PMID: 12974518BACKGROUND
  • Chang 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.

    PMID: 32766305BACKGROUND
  • Rezaei 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.

    PMID: 26156909BACKGROUND

MeSH Terms

Conditions

Congenital AbnormalitiesAnkyloglossiaTongue, FissuredGlossitis, Benign MigratoryMacroglossia

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesStomatognathic DiseasesTongue DiseasesMouth DiseasesGlossitis

Study Officials

  • Randa Abd Al Gawad, Dental PhD

    Cairo University

    STUDY DIRECTOR
  • Yasmin Yousry, Dental PhD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 22, 2023

Study Start

March 25, 2023

Primary Completion

June 1, 2023

Study Completion

August 10, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Data to be shared via email to other researchers if needed.

Shared Documents
STUDY PROTOCOL
Time Frame
data will be available starting June 2023 for 1 year

Locations