NCT05670652

Brief Summary

The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
362

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

December 6, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

December 6, 2022

Last Update Submit

February 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary molar relationship

    Categorical (Flush terminal plane, mesial step, distal step)

    Day 1

Secondary Outcomes (8)

  • Primary canine relationship

    Day 1

  • Physiological spaces (Upper and lower)

    Day 1

  • Primate spaces (Upper and lower)

    Day 1

  • Crowding (upper and lower)

    Day 1

  • Midline discrepancy

    Day 1

  • +3 more secondary outcomes

Interventions

Clinical examination with optimal (Lighting, using a disposable mouth mirror and a millimeter-ruler) will be performed, in addition to an upper and lower arch impression will be made and a study cast will be prepared.

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Egyptian children aged from 3-6 years old

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 35810281BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Sherine Badr Youness, prof dr

    Cairo University

    STUDY DIRECTOR
  • Shereen Hassan El-Shamy, dr

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Faisal Ali Aljarallah, master degree

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 6, 2022

First Posted

January 4, 2023

Study Start

April 1, 2023

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

February 21, 2023

Record last verified: 2023-02