Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in Rural Region, Dendera Center in Egypt

NCT07138456 | Not Yet Recruiting

• 1 other identifier: prevalence and severity of DF
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of our observational study is evaluation of the clinical severity of dental fluorosis and associated risk factors among a group of children (8-12 years old) in a rural region, Dendera center, Egypt. The main question it aims to answer is: What is the clinical severity of dental fluorosis and associated risk factors among a group of children (8-12 years old) in a rural region, Dendera center, Egypt?

Conditions

Dental Fluorosis

Keywords

prevalence, clinical severity and risk factors of dental fluorosis in a rural area in Egypt

Outcome Measures

Primary Outcomes (1)

• Clinically evident dental fluorosis in permanent incisors (prevalence)

  Clinical examination (using a probe and mouth mirror in bright daily life, using ICMR index which have the following scores 0: no fluorosis /1: mild fluorosis \_ 2: moderate fluorosis / 3: severe fluorosis)

  Baseline (during the initial clinical examination of the child)

Secondary Outcomes (3)

• Clinically evident dental fluorosis in all permanent teeth present other than permanent incisors (prevalence)

  Baseline (during the initial clinical examination of the child)

• Risk factors of dental fluorosis

  baseline (upon enrollment, after parents complete the questionnaire)

• Severity of dental fluorosis

  Baseline (during the initial clinical examination of the child)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Thy should be children with age range from 8 to 12 years, who have lived in the area of study since birth. the teeth to be examined should be clean and not covered with fillings or braces. the parents and children should accept to participate in the study and the parents should sign a consent according to ethical consideration.

You may qualify if:

• Children age range from 8 to 12 years.
• Children have lived in the area of the study since birth.
• Teeth to be examined should not be covered with fillings or braces.

You may not qualify if:

• Parents or children who refuse to participate in the study.
• Ethical consideration.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dendera region

Cairo, Qena Governorate, 83511, Egypt

Location

MeSH Terms

Conditions

Fluorosis, Dental

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• sarah A Mahmoud, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Gihad M Abdelraheem, Master

CONTACT

Egypt: +201095472833; gihad.mohamed@dentistry.cu.edu.eg

Ghadeer M Sayed, master

CONTACT

Egypt: +201023724105; ghadeer.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gihad Mohamed Abdelraheem Abdelmajeed

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)