NCT03746990

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,935

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 16, 2018

Last Update Submit

November 16, 2018

Conditions

Keywords

fluoridemottlinglibyafluorosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Libyan children born and lived in the same area. 2. Limited to incisors only.

You may not qualify if:

  • Non- Libyan children. 2. Children who born or lived outside the study areas. 3. Incisors with class II fracture (Ellis type 1970) or crowned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fluorosis, DentalFluoride Poisoning

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPoisoningChemically-Induced Disorders

Study Officials

  • suleiman r ergieg, Phd

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 20, 2018

Study Start

January 10, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share