- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746990
Presence of Enamel Fluorosis in Libyan Children
Evaluation of Degree of Enamel Fluorosis in Children of Tobruk and Kufra Regions in Libya
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Libyan children born and lived in the same area. 2. Limited to incisors only.
Exclusion Criteria:
- Non- Libyan children. 2. Children who born or lived outside the study areas. 3. Incisors with class II fracture (Ellis type 1970) or crowned
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
From baseline to 5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: suleiman r ergieg, Phd, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6/24/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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