Presence of Enamel Fluorosis in Libyan Children

Dental Fluorosis Clinical Trial

Official title:

Evaluation of Degree of Enamel Fluorosis in Children of Tobruk and Kufra Regions in Libya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746990
• Other study ID #: 6/24/17
• Status: Completed
• Start date: January 10, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: November 2018
• Source: Ajman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1935
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Fluorosis
• Fluoride Poisoning
• Fluorosis, Dental

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajman University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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