An observational study in Dental Fluorosis, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Cairo University · Observational
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?
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.
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.
Exclusion criteria:
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)
Time frame: Baseline (during the initial clinical examination of the child)
Clinically evident dental fluorosis in all permanent teeth present other than 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)
Time frame: Baseline (during the initial clinical examination of the child)
Risk factors of dental fluorosis
Multiple choice questions (questionnaire answered by the children's parents with multiple choice questions).
Time frame: baseline (upon enrollment, after parents complete the questionnaire)
Severity of dental fluorosis
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.
Time frame: Baseline (during the initial clinical examination of the child)
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University