NCT03751189

Brief 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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

November 18, 2018

Last Update Submit

November 21, 2018

Conditions

TraumaOverjet

Keywords

traumaoverjetlibyaschoolchildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Dental trauma among school children

    From baseline to 10 months

Eligibility Criteria

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

. Total of 2015 Libyan school children aged 7 to 16 years from urban (Tobruk) and rural (Kufra) areas were examined in the main study. The children were of almost equal number of both sexes from each age group

You may qualify if:

  • Libyan children.
  • The permanent incisors are present \& sufficiently erupted.

You may not qualify if:

  • Non Libyan children.
  • The permanent incisors are absent, or un-sufficiently erupted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and InjuriesOverbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2018

First Posted

November 23, 2018

Study Start

May 10, 2016

Primary Completion

January 10, 2017

Study Completion

May 10, 2017

Last Updated

November 23, 2018

Record last verified: 2018-11