- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03751189
Role of Overjet and Trauma in Libyan Children
November 21, 2018 updated by: sudhir rama varma
Trauma to Permanent Incisors and Overjet in Libyan Children
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
Study Overview
Detailed 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
Study Type
Observational
Enrollment (Actual)
1900
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of school children with overjet
Time Frame: From baseline to 10 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental trauma among school children
Time Frame: From baseline to 10 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2016
Primary Completion (Actual)
January 10, 2017
Study Completion (Actual)
May 10, 2017
Study Registration Dates
First Submitted
November 18, 2018
First Submitted That Met QC Criteria
November 21, 2018
First Posted (Actual)
November 23, 2018
Study Record Updates
Last Update Posted (Actual)
November 23, 2018
Last Update Submitted That Met QC Criteria
November 21, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma
-
Humacyte, Inc.CompletedTrauma | Trauma Injury | Trauma, Multiple | Trauma BluntUkraine
-
Arrowhead Regional Medical CenterCompletedTrauma Injury | Trauma Blunt | Vascular TraumaUnited States
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedTrauma Injury | Trauma, MultipleTurkey
-
University Hospital, AngersRecruiting
-
Wonju Severance Christian HospitalNational Research Foundation of KoreaCompletedTrauma Injury | Trauma, MultipleKorea, Republic of
-
Rabin Medical CenterIsraeli Ministry of SecurityUnknown
-
Hospital Departamental de VillavicencioCooperative University of Colombia; Clínica PrimaveraRecruitingTrauma Injury | Trauma Patients in ICU | Trauma (Including Fractures) | Trauma Patients | Trauma ICU PatientsColombia
-
Oslo University HospitalUniversity of Oslo; Sunnaas Rehabilitation Hospital; South-Eastern Norway Regional...RecruitingTrauma Injury | Trauma, Multiple | PolytraumaNorway
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.CompletedHead Injury Trauma BluntUnited States
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Francophone Pediatric Resuscitation...Completed