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NCT Number: NCT06352385

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.

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Key information

Age range

4 year–20 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dental Aesthetic Index of each age group

    Time frame: recruitment until December 2026

    Fill in the questionnaire through clinical examination,then calculate Dental Aesthetic Index according to the results of the questionnaire

  2. Index of Orthodontic Treatment Need of each age group

    Time frame: recruitment until December 2026

    Fill in the questionnaire through clinical examination,then calculate Index of Orthodontic Treatment Need according to the results of the questionnaire

Other outcomes

  1. dietary habit

    Time frame: recruitment until December 2026

    Questionnaire survey

  2. oral hygiene habits

    Time frame: recruitment until December 2026

    Questionnaire survey

  3. Bad oral habit

    Time frame: recruitment until December 2026

    Questionnaire survey

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Liu, PhD

CONTACT

[email protected]

19821231579

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

A Comprehensive Epidemiological Investigation of Malocclusion in China

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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