Dental FluorosisNCT07138456
Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in Rural Region, Dendera Center in Egypt
An observational study of Dental Fluorosis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fluorosis
- How many people
- 231 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2026to 20 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Parents or children who refuse to participate in the study.
- Ethical consideration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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?
Read the detailed description
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.
- Conditions
- Dental Fluorosis
- Keywords
- prevalence, clinical severity and risk factors of dental fluorosis in a rural area in Egypt
- Medical subject headings
- Fluorosis, Dental
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: 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).
Measured: 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.
Measured: Baseline (during the initial clinical examination of the child)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start20 Feb 2026 (estimated)
- Primary completion20 May 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental FluorosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gihad Mohamed Abdelraheem Abdelmajeed, Cairo University
- Investigators
- sarah A Mahmoud, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138456
- Sponsor's protocol ID
- prevalence and severity of DF
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07138456
- Acronym / sponsor ID
- prevalence and severity of DF
- Conditions
- Dental Fluorosis
- Keywords
- prevalence, clinical severity and risk factors of dental fluorosis in a rural area in Egypt
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Parents or children who refuse to participate in the study.
- Ethical consideration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
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)
Risk factors of dental fluorosis
Time frame: baseline (upon enrollment, after parents complete the questionnaire)
Severity of dental fluorosis
Time frame: Baseline (during the initial clinical examination of the child)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Dental Fluorosis
Enrolling by invitation
Design of a Multicomponent Intervention to Reduce the Risk of Exposure Fluorine
Fluorosis, Dental, Fluorosis
Active, not recruiting
Design of a Multicomponent Intervention to Reduce the Risk of Exposure Fluorine
Fluorosis, Dental, Fluorosis
RecruitingObservational study
Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
Amelogenesis Imperfecta, Dental Fluoroses
Not yet recruitingPhase 4
21% Hydrochloric Acid Based Versus 6.6 % Hydrochloric Based Micro Abrasive Kit in Management of Patients With Mild to Moderate Fluorosis
Enamel Discoloration, Fluorosis, Dental
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
sarah A Mahmoud, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Fluorosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gihad M Abdelraheem, Master (Egypt: +201095472833, gihad.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically evident dental fluorosis in permanent incisors (prevalence) (time frame: Baseline (during the initial clinical examination of the child)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.