- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05670652
Assessment of the Occlusal Characteristics
February 20, 2023 updated by: Faisal Ali Jarallah Aljarallah, Cairo University
Assessment of the Occlusal Characteristics of the Primary Dentition Among Egyptian Pre-School Children
The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This cross-sectional study was based on examination of the primary dentition of healthy preschool Egyptian children ,The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.
Study Type
Observational
Enrollment (Anticipated)
362
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Faisal Ali Aljarallah, master degree
- Phone Number: +20 1016952338
- Email: F_uoh@hotmail.com
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
3 years to 6 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Egyptian children aged from 3-6 years old
Description
Inclusion Criteria:
- Egyptian children.
- Children are medically free.
- Children with a complete set of primary dentition without any permanent teeth. -Teeth free of extensive caries which affect the mesio- distal and occluso- gingival dimension.
Exclusion Criteria:
- Children with developmental anomalies.
- Children with any oral habits.
- Children with cognition problems.
- Children with a history of an obvious alternative cause for malocclusion (e.g. trauma, syndromes).
- Participant's caregivers refuse to give consent.
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
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary molar relationship
Time Frame: Day 1
|
Categorical (Flush terminal plane, mesial step, distal step)
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary canine relationship
Time Frame: Day 1
|
Categorical (Class 1, Class 2, Class3)
|
Day 1
|
|
Physiological spaces (Upper and lower)
Time Frame: Day 1
|
Binary (Present/absent)
|
Day 1
|
|
Primate spaces (Upper and lower)
Time Frame: Day 1
|
Binary (Present/absent)
|
Day 1
|
|
Crowding (upper and lower)
Time Frame: Day 1
|
Binary (Present/absent)
|
Day 1
|
|
Midline discrepancy
Time Frame: Day 1
|
Binary (Present/absent)
|
Day 1
|
|
Posterior Crossbite (unilateral/bilateral)
Time Frame: Day 1
|
Binary (Present/absent)
|
Day 1
|
|
Degree of overbite
Time Frame: Day 1
|
Categorical (Normal, increased, edge to edge or anterior open bite)
|
Day 1
|
|
Degree of overjet
Time Frame: Day 1
|
Categorical (Normal, increased, edge to edge or anterior crossbite)
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sherine Badr Youness, prof dr, Cairo university
- Study Director: Shereen Hassan El-Shamy, dr, Cairo university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Davidopoulou S, Arapostathis K, Berdouses ED, Kavvadia K, Oulis C. Occlusal features of 5-year-old Greek children: a cross-sectional national study. BMC Oral Health. 2022 Jul 9;22(1):281. doi: 10.1186/s12903-022-02303-1.
- BY Badr, S. and H Yahfoufi, S. (2020) 'ASSESSMENT OF THE OCCLUSALCHARACTERISTICS OF THE PRIMARY DENTITION AMONG LEBANESE PRE-SCHOOL CHILDREN: A BASE LINE STUDY CROSS-SECTIONAL STUDY', BAU Journal-Health and Wellbeing, 2(2), p. 5.
- El-Attar, H., Salama, R. and Hussien, A. (2020) 'Prevalence of malocclusion and common occlusal traits among adolescent school children in Dakahliya, Egypt and Makkah, Saudi Arabia (A comparative study)', Egyptian Orthodontic Journal, 57(June 2020), pp. 1-9.
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 (Anticipated)
April 1, 2023
Primary Completion (Anticipated)
February 1, 2024
Study Completion (Anticipated)
April 1, 2024
Study Registration Dates
First Submitted
December 6, 2022
First Submitted That Met QC Criteria
December 31, 2022
First Posted (Actual)
January 4, 2023
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- ocopd
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.
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