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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03751189
Other study ID # 07/16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2016
Est. completion date May 10, 2017

Study information

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

Clinical Trial Summary

Traumatic dental injuries are one of the commonly encountered dental emergencies. Missing anterior tooth in children due to any injury can be a source of considerable physical and psychological discomfort for the child. These consequences also have significant impact on parents, who are generally concerned with esthetic and economic aspects of this problem. It varies from small crack in the enamel to complete loss of the tooth. Injury to children teeth can be both painful and traumatic to the children


Description:

Traumatic injuries to anterior teeth have reported by several investigators. In Asia and Africa, the prevalence of TDI to anterior teeth among adolescents ranges from 4% to 35% and 15% to 21%, respectively and in America and Europe, the prevalence varied from 15% to 23% and 23% to 35%, respectively . 50% of school children have sustained traumatic injuries prior to graduation . A contributing factors make children susceptible to injuries have been widely investigated. These factors included Class-II, div.1 malocclusion, increased overjet . 71% to 92% of all injuries sustained in a lifetime occur before the age of 19 years, which occur at home, followed by school and public places.The aim of this study is to assess the mean overjet value in Libyan children and to examine the relationship between increased overjet and trauma to permanent incisor teeth


Recruitment information / eligibility

Status Completed
Enrollment 1900
Est. completion date May 10, 2017
Est. primary completion date January 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 16 Years
Eligibility Inclusion Criteria:

- Libyan children.

- The permanent incisors are present & sufficiently erupted.

Exclusion Criteria:

- Non Libyan children.

- The permanent incisors are absent, or un-sufficiently erupted.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
sudhir rama varma

Outcome

Type Measure Description Time frame Safety issue
Primary Number of school children with overjet Presence of overjet among school children, is evaluated by observational method,measured by 1-1mm-3mm;2-3mm-5mm;3-5mm< From baseline to 10 months
Secondary Dental trauma among school children Presence of trauma ,by observational method; Grading done by 0- No trauma;1-trauma related to incisal region;2-trauma related to mid half;3-trauma pertaining to cervical region From baseline to 10 months
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