Tooth Development DisorderNCT05670652
Assessment of the Occlusal Characteristics
An observational study of Tooth Development Disorder, run by Cairo University.
Trial summary
The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Tooth Development Disorder
- What is being tested?
- clinical examination
- How many people
- 362 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Child
Study population: Egyptian children aged from 3-6 years old
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Development Disorder
- Being tested
- clinical examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical examinationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary molar relationship
Categorical (Flush terminal plane, mesial step, distal step)
Measured: Day 1
Secondary outcomes (8)
Primary canine relationship
Categorical (Class 1, Class 2, Class3)
Measured: Day 1
Physiological spaces (Upper and lower)
Binary (Present/absent)
Measured: Day 1
Primate spaces (Upper and lower)
Binary (Present/absent)
Measured: Day 1
Crowding (upper and lower)
Binary (Present/absent)
Measured: Day 1
Midline discrepancy
Binary (Present/absent)
Measured: Day 1
Posterior Crossbite (unilateral/bilateral)
Binary (Present/absent)
Measured: Day 1
Degree of overbite
Categorical (Normal, increased, edge to edge or anterior open bite)
Measured: Day 1
Degree of overjet
Categorical (Normal, increased, edge to edge or anterior crossbite)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Apr 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth Development DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Ali Jarallah Aljarallah, Cairo University
- Investigators
- Sherine Badr Youness, prof dr, Study director, Cairo UniversityShereen Hassan El-Shamy, dr, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670652
- Sponsor's protocol ID
- ocopd
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35810281BY 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 at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Occlusal Characteristics of the Primary Dentition Among Egyptian Pre-School Children
- ClinicalTrials.gov ID
- NCT05670652
- Acronym / sponsor ID
- ocopd
- Conditions
- Tooth Development Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Egyptian children aged from 3-6 years old
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical examinationClinical 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. | Other | – |
Primary outcome
Primary molar relationship
Time frame: Day 1
Categorical (Flush terminal plane, mesial step, distal step)
8 secondary outcomes
Primary canine relationship
Time frame: Day 1
Physiological spaces (Upper and lower)
Time frame: Day 1
Primate spaces (Upper and lower)
Time frame: Day 1
Crowding (upper and lower)
Time frame: Day 1
Midline discrepancy
Time frame: Day 1
Posterior Crossbite (unilateral/bilateral)
Time frame: Day 1
Degree of overbite
Time frame: Day 1
Degree of overjet
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 35810281Davidopoulou 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.
- BackgroundBY 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.
- BackgroundEl-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherine Badr Youness, prof dr study director
Cairo University
Shereen Hassan El-Shamy, dr study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Development Disorder, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faisal Ali Aljarallah, master degree (1016952338 ext. +20, F_uoh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary molar relationship (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670652, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.