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NCT Number: NCT07138456

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

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?

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Key information

About this study

Fluoride has a dual impact, it can be beneficial for dental health when consumed at optimal levels, but excessive intake can lead to a condition known as dental fluorosis (DF).

Dental fluorosis, which is particularly common among children and young individuals, is a developmental enamel defect caused by excessive fluoride exposure during the critical stages of tooth formation. This condition affects both the appearance and structure of the enamel.

The severity of dental fluorosis depends on various factors, including fluoride concentration in drinking water, daily intake, duration of exposure, and climatic conditions.

Epidemiological studies indicate that fluorosis can affect individuals across different age groups, with cases ranging from mild dental fluorosis to severe skeletal fluorosis. Children are particularly vulnerable to its harmful effects, which are often irreversible.

In rural areas, groundwater serves as the primary source of drinking water due to limited access to treated water supplies.

This dependence on groundwater increases the risk of prolonged fluoride exposure, particularly among children, whose developing teeth are more susceptible to fluorosis.

While several studies have documented the prevalence of dental fluorosis globally, there is a lack of data on its prevalence in rural areas of Upper Egypt, where groundwater is a key water source.

This knowledge gap highlights the need for localized research to assess the extent of the issue and develop targeted interventions.

Therefore, a cross-sectional study will be conducted to determine the prevalence and severity of dental fluorosis and identify associated risk factors among children in a rural area of the Dendera district, Qena governorate, Upper Egypt.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Clinically evident dental fluorosis in permanent incisors (prevalence)

    Time frame: Baseline (during the initial clinical examination of the child)

    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)

Secondary outcomes

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

    Time frame: Baseline (during the initial clinical examination of the child)

    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)

  2. Risk factors of dental fluorosis

    Time frame: baseline (upon enrollment, after parents complete the questionnaire)

    Multiple choice questions (questionnaire answered by the children's parents with multiple choice questions).

  3. Severity of dental fluorosis

    Time frame: Baseline (during the initial clinical examination of the child)

    Scoring (0-3) according to Indian Council of Medical Research (ICMR) index which have the following scores 0: no fluorosis /1: mild fluorosis _ 2: moderate fluorosis / 3: severe fluorosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghadeer M Sayed, master

CONTACT

[email protected]

Egypt: +201023724105

Gihad M Abdelraheem, Master

CONTACT

[email protected]

Egypt: +201095472833

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in a Rural Region, Dendera Center in Egypt: A Cross-Sectional Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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