Dental FluorosisNCT03746990
Presence of Enamel Fluorosis in Libyan Children
An observational study of Dental Fluorosis, run by Ajman University.
Trial summary
Fluorosis is caused by hypomineralization in the enamel due to increased fluoride ingestion during early childhood (Cawson.1, Wong et al. 2, and Sudhir 3). A considerable amount of evidence has been reported over the years, which has shown that presence of fluoride ions at up to one part per million in public water… Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fluorosis
- How many people
- 1,935 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2017to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study is part of a cross - sectional investigation of aspects of dental health in rural and urban Libyan school children. Total of 2015 Libyan school children aged 7 to 16 years, from urban (Tobruk) and rural (Kufra) areas were included in the main study. The children were of almost equal number of both sexes from each age group (table-I) .The total of 1935 children were examined for enamel fluorosis, the remaining, eighty children were excluded because they failed to meet inclusive criteria.
Who may be able to join
- Libyan children born and lived in the same area. 2. Limited to incisors only.
Who cannot join
- Non- Libyan children. 2. Children who born or lived outside the study areas. 3. Incisors with class II fracture (Ellis type 1970) or crowned
About this study
Official title: Evaluation of Degree of Enamel Fluorosis in Children of Tobruk and Kufra Regions in Libya
Fluorosis is caused by hypomineralization in the enamel due to increased fluoride ingestion during early childhood (Cawson.1, Wong et al. 2, and Sudhir 3). A considerable amount of evidence has been reported over the years, which has shown that presence of fluoride ions at up to one part per million in public water supply has reduced the prevalence of teeth decayed with minimal chance of dental fluorosis. The WHO recognized these facts by its resolution in 1969 4 and 1975 5, which stated that water fluoridation, where applicable, should be the cornerstone of any national policy of caries prevention
Read the detailed description
The optimal concentration is defined as that which gives maximal protection against dental caries, with minimal clinically observable dental fluorosis (Dunning 7). This level is determined according to the climate and the resultant drinking habits (Newborn 6). Cawson 1 stated that mottling of enamel is the most frequently seen and most reliable sign of excessive quantities of fluoride in the drinking water. Dean 8 concluded that a fluoride level of above 1ppm does not significantly reduce caries beyond the optimal effect of 1ppm.
Different classifications have been introduce to score dental fluorosis. (Dean 9, Al -Alousi 10, Thylstrup \& Fejerskov 11, (Fejerskov, 12). and the DDE index by FDI 1982). Aira Sabokseir 13, concluded, fluorosis indices, if used alone, could result in misdiagnosis of dental fluorosis and information about adverse health-related conditions linked to DDEs (Developmental Defects of Enamel) at specific positions on teeth could help to differentiate between genuine fluorosis and fluorosis-resembling defects.Various figures for mouth prevalence of enamel fluorosis have been reported by different investigators. 39.2% by Al-Alousi 10, for Welsh children, 32% by Akpata 14 for Nigerian children. Using the DDE index of the FDI (1982), Al alousi 10 defective enamel of 48.9% in children from south Wales. In England,Tabari 15 found the prevalence of fluorosis was 54% in the fluoridated area and 23% in the fluoride-deficient area. In Iran the prevalence of fluorosis was 61% (Azami-Aghdash et al., 16).
- Conditions
- Dental Fluorosis
- Keywords
- fluoride, mottling, libya, fluorosis
- Medical subject headings
- Fluorosis, Dental, Fluoride Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observational | Total of 2015 Libyan school children aged 7 to 16 years, from urban (Tobruk) and rural (Kufra) areas were included in the main study. The children were of almost equal number of both sexes from each age group (table-I) .The total of 1935 children were examined for enamel fluorosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading of mottling
If there was fluorosis, the tooth or teeth were diagnosed as having fluorosis and coded according to the method produced by Al- Alousi 10, as follows A. White areas less than 2mm in diameter. B. White areas of or greater than 2mm in diameter. C. Colored (brown) areas less than 2mm in diameter, irrespective of there being any white areas.
- Colored (brown) areas of or greater than 2mm in dimeter, irrespective of there being any white area.
- Horizontal white lines irrespective of there being any white, non-linear areas.
- Colored (brown) or hypo-plastic areas.
Measured: From baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start10 Jan 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
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.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,935 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sudhir rama varma, Ajman University
- Investigators
- suleiman r ergieg, Phd, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746990
- Sponsor's protocol ID
- 6/24/17
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 20 Nov 2018
- 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 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Degree of Enamel Fluorosis in Children of Tobruk and Kufra Regions in Libya
- ClinicalTrials.gov ID
- NCT03746990
- Acronym / sponsor ID
- 6/24/17
- Conditions
- Dental Fluorosis
- Keywords
- fluoride, mottling, libya, fluorosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,935 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 20 Nov 2018 (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.
Fluorosis is caused by hypomineralization in the enamel due to increased fluoride ingestion during early childhood (Cawson.1, Wong et al. 2, and Sudhir 3). A considerable amount of evidence has been reported over the years, which has shown that presence of fluoride ions at up to one part per million in public water supply has reduced the prevalence of teeth decayed with minimal chance of dental fluorosis. The WHO recognized these facts by its resolution in 1969 4 and 1975 5, which stated that water fluoridation, where applicable, should be the cornerstone of any national policy of caries prevention
Detailed description
The optimal concentration is defined as that which gives maximal protection against dental caries, with minimal clinically observable dental fluorosis (Dunning 7). This level is determined according to the climate and the resultant drinking habits (Newborn 6). Cawson 1 stated that mottling of enamel is the most frequently seen and most reliable sign of excessive quantities of fluoride in the drinking water. Dean 8 concluded that a fluoride level of above 1ppm does not significantly reduce caries beyond the optimal effect of 1ppm.
Different classifications have been introduce to score dental fluorosis. (Dean 9, Al -Alousi 10, Thylstrup \& Fejerskov 11, (Fejerskov, 12). and the DDE index by FDI 1982). Aira Sabokseir 13, concluded, fluorosis indices, if used alone, could result in misdiagnosis of dental fluorosis and information about adverse health-related conditions linked to DDEs (Developmental Defects of Enamel) at specific positions on teeth could help to differentiate between genuine fluorosis and fluorosis-resembling defects.Various figures for mouth prevalence of enamel fluorosis have been reported by different investigators. 39.2% by Al-Alousi 10, for Welsh children, 32% by Akpata 14 for Nigerian children. Using the DDE index of the FDI (1982), Al alousi 10 defective enamel of 48.9% in children from south Wales. In England,Tabari 15 found the prevalence of fluorosis was 54% in the fluoridated area and 23% in the fluoride-deficient area. In Iran the prevalence of fluorosis was 61% (Azami-Aghdash et al., 16).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | – | –Total of 2015 Libyan school children aged 7 to 16 years, from urban (Tobruk) and rural (Kufra) areas were included in the main study. The children were of almost equal number of both sexes from each age group (table-I) .The total of 1935 children were examined for enamel fluorosis |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study is part of a cross - sectional investigation of aspects of dental health in rural and urban Libyan school children. Total of 2015 Libyan school children aged 7 to 16 years, from urban (Tobruk) and rural (Kufra) areas were included in the main study. The children were of almost equal number of both sexes from each age group (table-I) .The total of 1935 children were examined for enamel fluorosis, the remaining, eighty children were excluded because they failed to meet inclusive criteria.
Key inclusion criteria (1 listed)
- Libyan children born and lived in the same area. 2. Limited to incisors only.
Key exclusion criteria (1 listed)
- Non- Libyan children. 2. Children who born or lived outside the study areas. 3. Incisors with class II fracture (Ellis type 1970) or crowned
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
Grading of mottling
Time frame: From baseline to 5 months
If there was fluorosis, the tooth or teeth were diagnosed as having fluorosis and coded according to the method produced by Al- Alousi 10, as follows A. White areas less than 2mm in diameter. B. White areas of or greater than 2mm in diameter. C. Colored (brown) areas less than 2mm in diameter, irrespective of there being any white areas. D. Colored (brown) areas of or greater than 2mm in dimeter, irrespective of there being any white area. E. Horizontal white lines irrespective of there being any white, non-linear areas. F. Colored (brown) or hypo-plastic areas.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- 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
Not yet recruitingObservational study
Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in Rural Region, Dendera Center in Egypt
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. This study is not recruiting at the moment.
suleiman r ergieg, Phd principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Fluorosis, run by Ajman University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of mottling (time frame: From baseline to 5 months). 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 20 Nov 2018.