Presence of Enamel Fluorosis in Libyan Children

NCT ID: NCT03746990

Last Updated: 2018-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1935 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-10

Study Completion Date

2017-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Fluorosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ajman University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sudhir rama varma

ASSISTANT PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

suleiman r ergieg, Phd

Role: PRINCIPAL_INVESTIGATOR

Professor

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6/24/17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of Fissure Sealants on Primary Molars
NCT01438866 COMPLETED PHASE4