ClinicalTrials.gg
Not yet recruitingNCT06352385Updated May 14, 2025

Epidemiological Investigation of Malocclusion in China

An observational study in Epidemiological Investigation and Malocclusion, sponsored by Shanghai Jiao Tong University School of Medicine. Not yet recruiting. Open to participants aged 4 Years to 20 Years. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
19,847
Ages
4 Years to 20 Years
Sex
All
01

Study 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. 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:

  1. 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;
  2. Establishing China's orthodontic treatment demand index offers vital support for the advancement of orthodontics and oral healthcare.;
  3. 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.

02

Conditions studied

  • Epidemiological Investigation
  • Malocclusion

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03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 19,847 is above the median of 63 across 74 observational studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Individuals with all genders;
  2. Individuals with good general health;
  3. Individuals with no history of orthodontic treatment or other maxillofacial surgical interventions;
  4. Individuals who agree to and are willing to sign the form.

Exclusion criteria

Exclusion Criteria:

  1. Individuals diagnosed with genetic or systemic disorders;
  2. Individuals with a recent (within the past 3 months) history of maxillofacial trauma;
  3. Individuals who are incapable of undergoing oral examinations or completing the necessary questionnaires.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
19,847 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: recruitment until December 2026

Secondary outcomes

  1. 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

    Time frame: recruitment until December 2026

  2. 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

    Time frame: recruitment until December 2026

Other outcomes

  1. dietary habit

    Questionnaire survey

    Time frame: recruitment until December 2026

  2. oral hygiene habits

    Questionnaire survey

    Time frame: recruitment until December 2026

  3. Bad oral habit

    Questionnaire survey

    Time frame: recruitment until December 2026

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2025; primary completion for Dec 2026, 19 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2024
First posted
Apr 8, 2024
StartEst.
May 2025
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
May 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06352385
Responsible party
Bing Fang (Professor, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Apr 8, 2024
Start date
May 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 14, 2025

Study contacts

Chao Liu, PhD
Contact
120116@sh9hospital.org.cn
19821231579
Bing Fang, PhD
principal investigator · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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