Epidemiological InvestigationNCT06352385
Epidemiological Investigation of Malocclusion in China
An observational study of Epidemiological Investigation and Malocclusion, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. Notably, the last comprehensive national prevalence data on malocclusion in China, which encompassed a significant sample size, dates back over two decades. Read more about this study
- Who is it for?
- Ages 4 to 20 years
- Conditions the study is for
- Epidemiological Investigation, Malocclusion
- How many people
- 19,847 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Dec 2026
- How long will I take part?
- 1 Day
- 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 4 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study included four age groups: students aged 4-6 years (senior grade of kindergarten),9-11 years (fourth grade in primary school),13-15 years (eighth grade),and 17-20 years (freshman in college).
Who may be able to join
- Individuals with all genders;
- Individuals with good general health;
- Individuals with no history of orthodontic treatment or other maxillofacial surgical interventions;
- Individuals who agree to and are willing to sign the informed consent form.
Who cannot join
- Individuals diagnosed with genetic or systemic disorders;
- Individuals with a recent (within the past 3 months) history of maxillofacial trauma;
- Individuals who are incapable of undergoing oral examinations or completing the necessary questionnaires.
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
Official title: A Comprehensive Epidemiological Investigation of Malocclusion in China
Malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. Notably, the last comprehensive national prevalence data on malocclusion in China, which encompassed a significant sample size, dates back over two decades. Given the evolving nature of these epidemiological metrics, such as prevalence rates, it is imperative to update our understanding. Consequently, there is an urgent need for China to undertake a unified, standardized epidemiological survey of malocclusion with a substantial sample size to ensure accurate and timely data collection.
Read the detailed description
With the improvement of our country's living and cultural level, orthodontic treatment for malocclusion has emerged as a critical need that significantly impacts individuals' physical and mental wellbeing, as well as their social life in contemporary society. To obtain the prevalence rate, demand index and risk factor analysis of malocclusion in China serves as a fundamental prerequisite for effective diagnosis, identifying the optimal treatment window, and devising tailored treatment plans.
The purpose of this study is as follows:
- Obtaining epidemiological data such as the prevalence rate of malocclusion is the cornerstone of prevention and treatment of malocclusion, and is also the prerequisite of carrying out a series of studies;
- Establishing China's orthodontic treatment demand index offers vital support for the advancement of orthodontics and oral healthcare.;
- Updating and enhancing X-ray head image measurement normal reference value provides a more scientific and objective foundation for orthodontic planning, improves the level of diagnosis and treatment, and fosters the development of related disciplines.
The implementation of this project will not only foster an improvement in the overall oral health of the populace but also establish a scientific foundation for oral medicine research and the development of prevention and treatment strategies.
- Conditions
- Epidemiological Investigation, Malocclusion
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children aged 4 -6 | This is a non intervention-observation only study. | |
| Children aged 9 -11 | This is a non intervention-observation only study. | |
| Students aged 13 -15 | This is a non intervention-observation only study. | |
| Students aged 17-20 | This is a non intervention-observation only study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence rate of malocclusion
The Index of Orthodontic Treatment Need and Dental Aesthetic Index were used to record the Malocclusion deformities,The Index of Orthodontic Treatment Need or Dental Aesthetic Index ≥3 is recorded as Malocclusion.The prevalence rate of malocclusion was the number of cases of Malocclusion /the total number of investigated cases during the research investigation.
Measured: recruitment until December 2026
Secondary outcomes (2)
Dental Aesthetic Index of each age group
Fill in the questionnaire through clinical examination,then calculate Dental Aesthetic Index according to the results of the questionnaire
Measured: recruitment until December 2026
Index of Orthodontic Treatment Need of each age group
Fill in the questionnaire through clinical examination,then calculate Index of Orthodontic Treatment Need according to the results of the questionnaire
Measured: recruitment until December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startMay 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidemiological InvestigationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19,847 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Fang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Bing Fang, PhD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352385
- Sponsor's protocol ID
- SH9H-2024-TK16-1.0
- Status last verified
- Apr 2025
- First submitted
- 22 Mar 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Epidemiological Investigation of Malocclusion in China
- ClinicalTrials.gov ID
- NCT06352385
- Acronym / sponsor ID
- SH9H-2024-TK16-1.0
- Conditions
- Epidemiological Investigation, Malocclusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 19,847 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Apr 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.
Malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. Notably, the last comprehensive national prevalence data on malocclusion in China, which encompassed a significant sample size, dates back over two decades. Given the evolving nature of these epidemiological metrics, such as prevalence rates, it is imperative to update our understanding. Consequently, there is an urgent need for China to undertake a unified, standardized epidemiological survey of malocclusion with a substantial sample size to ensure accurate and timely data collection.
Detailed description
With the improvement of our country's living and cultural level, orthodontic treatment for malocclusion has emerged as a critical need that significantly impacts individuals' physical and mental wellbeing, as well as their social life in contemporary society. To obtain the prevalence rate, demand index and risk factor analysis of malocclusion in China serves as a fundamental prerequisite for effective diagnosis, identifying the optimal treatment window, and devising tailored treatment plans.
The purpose of this study is as follows:
- Obtaining epidemiological data such as the prevalence rate of malocclusion is the cornerstone of prevention and treatment of malocclusion, and is also the prerequisite of carrying out a series of studies;
- Establishing China's orthodontic treatment demand index offers vital support for the advancement of orthodontics and oral healthcare.;
- Updating and enhancing X-ray head image measurement normal reference value provides a more scientific and objective foundation for orthodontic planning, improves the level of diagnosis and treatment, and fosters the development of related disciplines.
The implementation of this project will not only foster an improvement in the overall oral health of the populace but also establish a scientific foundation for oral medicine research and the development of prevention and treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children aged 4 -6 | – | –This is a non intervention-observation only study. |
| Children aged 9 -11 | – | –This is a non intervention-observation only study. |
| Students aged 13 -15 | – | –This is a non intervention-observation only study. |
| Students aged 17-20 | – | –This is a non intervention-observation only study. |
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study included four age groups: students aged 4-6 years (senior grade of kindergarten),9-11 years (fourth grade in primary school),13-15 years (eighth grade),and 17-20 years (freshman in college).
Key inclusion criteria (4 listed)
- Individuals with all genders;
- Individuals with good general health;
- Individuals with no history of orthodontic treatment or other maxillofacial surgical interventions;
- Individuals who agree to and are willing to sign the informed consent form.
Key exclusion criteria (3 listed)
- Individuals diagnosed with genetic or systemic disorders;
- Individuals with a recent (within the past 3 months) history of maxillofacial trauma;
- Individuals who are incapable of undergoing oral examinations or completing the necessary questionnaires.
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
The Prevalence rate of malocclusion
Time frame: recruitment until December 2026
The Index of Orthodontic Treatment Need and Dental Aesthetic Index were used to record the Malocclusion deformities,The Index of Orthodontic Treatment Need or Dental Aesthetic Index ≥3 is recorded as Malocclusion.The prevalence rate of malocclusion was the number of cases of Malocclusion /the total number of investigated cases during the research investigation.
2 secondary outcomes
Dental Aesthetic Index of each age group
Time frame: recruitment until December 2026
Index of Orthodontic Treatment Need of each age group
Time frame: recruitment until December 2026
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 14 May 2025.
- Individual participant dataSharing planned: No
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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.
Bing Fang, PhD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiological Investigation and Malocclusion, run by Shanghai Jiao Tong University School of Medicine.
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 4 inclusion and 3 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 14 May 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 Chao Liu, PhD (19821231579, 120116@sh9hospital.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Prevalence rate of malocclusion (time frame: recruitment until December 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.