OcclusionNCT06402045
Assessment of the Occlusal Characteristics and Orthodontic Treatment Needs for Egyptian Children( 6-12)Years Old
An observational study of Occlusion, run by Salma Hassan Widatalla Omar.
Trial summary
The objective of this study is to assess the occlusal characteristics of Egyptian children 6-12 years old and their need for orthodontic treatment. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Occlusion
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Egyptian children of both genders born to Egyptian parents . Children having an age range from 6-12 years old.
Who may be able to join
- Egyptian children of both genders born to Egyptian parents .
- Children having an age range from 6-12 years old.
- Cooperative children .
Who cannot join
- Craniofacial anomalies that affect jaw relation and dentition except for cleft lip and palate.
- History of facial trauma or surgery.
- Systemic disease that affects craniofacial growth
- Previously orthodontically treated child Those whom did not sign the consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this study is to assess the occlusal characteristics of Egyptian children 6-12 years old and their need for orthodontic treatment.
Read the detailed description
The term malocclusion encompasses all deviations of teeth and jaws from normal alignment and relations including discrepancies between teeth and jaw size, malposition of individual teeth ,and mal-relationship of the dental arches in sagittal ,transverse, and vertical dimensions. The etiology of malocclusion may be due to genetic factors , environmental factors or more commonly a combination of both inherited and environmental acting together such as adverse oral habits , anomalies in number ,form ,and developmental position of teeth can cause malocclusion .The recognition of these disorders in dentistry implies the need for planning preventive ,interceptive ,and corrective orthodontic measures to provide adequate treatment .for such planning ,it is essential to carry out epidemiological studies of malocclusion prevalence and to assess the treatment need for such disorders ,so that early recognition of developing malocclusions and the potential for uncomplicated orthodontic treatment procedures can minimize or eliminate future costly treatment .
- Conditions
- Occlusion
- Medical subject headings
- Bites and Stings
What is being measured
The primary outcome is the main question the study is designed to answer.
Molar relationship (angle classification)
occlusion characteristics
Measured: one year
Secondary outcomes (6)
crowding
occlusion characteristics
Measured: one year
Degree of overbite
occlusion characteristics
Measured: one year
Degree of overjet
occlusion characteristics
Measured: one year
Open bite
occlusion characteristics
Measured: one year
Assessment of orthodontic treatment needs
occlusion characteristics
Measured: one year
Posterior crossbite (unilateral, bilateral)
occlusion characteristics
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (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 OcclusionStudies of the same condition, open and under way.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salma Hassan Widatalla Omar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salma Hassan Widatalla Omar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402045
- Sponsor's protocol ID
- ocop
- Status last verified
- Feb 2025
- First submitted
- 30 Apr 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alhammadi MS, Halboub E, Fayed MS, Labib A, El-Saaidi C. Global distribution of malocclusion traits: A systematic review. Dental Press J Orthod. 2018 Nov-Dec;23(6):40.e1-40.e10. doi: 10.1590/2177-6709.23.6.40.e1-10.onl.
PubMed 30672991Akbari M, Lankarani KB, Honarvar B, Tabrizi R, Mirhadi H, Moosazadeh M. Prevalence of malocclusion among Iranian children: A systematic review and meta-analysis. Dent Res J (Isfahan). 2016 Sep;13(5):387-395. doi: 10.4103/1735-3327.192269.
PubMed 27857763Nur Yilmaz RB, Oktay I, Ilhan D, Fisekcioglu E, Ozdemir F. Normative and subjective need for orthodontic treatment within different age groups in a population in Turkey. Niger J Clin Pract. 2017 Dec;20(12):1632-1638. doi: 10.4103/1119-3077.224126.
PubMed 29378999
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Occlusal Characteristics and Orthodontic Treatment Needs for Egyptian Children( 6-12)Years Old
- ClinicalTrials.gov ID
- NCT06402045
- Acronym / sponsor ID
- ocop
- Conditions
- Occlusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Salma Hassan Widatalla OmarUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 7 May 2024 (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 Egyptian children 6-12 years old and their need for orthodontic treatment.
Detailed description
The term malocclusion encompasses all deviations of teeth and jaws from normal alignment and relations including discrepancies between teeth and jaw size, malposition of individual teeth ,and mal-relationship of the dental arches in sagittal ,transverse, and vertical dimensions. The etiology of malocclusion may be due to genetic factors , environmental factors or more commonly a combination of both inherited and environmental acting together such as adverse oral habits , anomalies in number ,form ,and developmental position of teeth can cause malocclusion .The recognition of these disorders in dentistry implies the need for planning preventive ,interceptive ,and corrective orthodontic measures to provide adequate treatment .for such planning ,it is essential to carry out epidemiological studies of malocclusion prevalence and to assess the treatment need for such disorders ,so that early recognition of developing malocclusions and the potential for uncomplicated orthodontic treatment procedures can minimize or eliminate future costly treatment .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Egyptian children of both genders born to Egyptian parents . Children having an age range from 6-12 years old.
Key inclusion criteria (3 listed)
- Egyptian children of both genders born to Egyptian parents .
- Children having an age range from 6-12 years old.
- Cooperative children .
Key exclusion criteria (4 listed)
- Craniofacial anomalies that affect jaw relation and dentition except for cleft lip and palate.
- History of facial trauma or surgery.
- Systemic disease that affects craniofacial growth
- Previously orthodontically treated child Those whom did not sign the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Molar relationship (angle classification)
Time frame: one year
occlusion characteristics
6 secondary outcomes
crowding
Time frame: one year
Degree of overbite
Time frame: one year
Degree of overjet
Time frame: one year
Open bite
Time frame: one year
Assessment of orthodontic treatment needs
Time frame: one year
Posterior crossbite (unilateral, bilateral)
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 30672991Alhammadi MS, Halboub E, Fayed MS, Labib A, El-Saaidi C. Global distribution of malocclusion traits: A systematic review. Dental Press J Orthod. 2018 Nov-Dec;23(6):40.e1-40.e10. doi: 10.1590/2177-6709.23.6.40.e1-10.onl.
- Background: PubMed 27857763Akbari M, Lankarani KB, Honarvar B, Tabrizi R, Mirhadi H, Moosazadeh M. Prevalence of malocclusion among Iranian children: A systematic review and meta-analysis. Dent Res J (Isfahan). 2016 Sep;13(5):387-395. doi: 10.4103/1735-3327.192269.
- Background: PubMed 29378999Nur Yilmaz RB, Oktay I, Ilhan D, Fisekcioglu E, Ozdemir F. Normative and subjective need for orthodontic treatment within different age groups in a population in Turkey. Niger J Clin Pract. 2017 Dec;20(12):1632-1638. doi: 10.4103/1119-3077.224126.
- cross sectional studyLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Occlusion, run by Salma Hassan Widatalla Omar.
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 4 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: opening soon, as of the sponsor's last update on 18 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact salma widatalla (+971 055466 0010, salma-omar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molar relationship (angle classification) (time frame: one year). 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 NCT06402045, 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 18 Feb 2025.