Epidemiological Investigation of Malocclusion in China

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malocclusion; Epidemiological Investigation

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.

• Study Type: Observational
• Enrollment (Estimated): 19847

Contacts and Locations

• Study Contact: Name: Chao Liu, PhD; Phone Number: 19821231579; Email: 120116@sh9hospital.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• 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).

Description

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 informed consent form.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	recruitment until December 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	recruitment until December 2026

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
dietary habit	Questionnaire survey	recruitment until December 2026
oral hygiene habits	Questionnaire survey	recruitment until December 2026
Bad oral habit	Questionnaire survey	recruitment until December 2026

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Bing Fang, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: SH9H-2024-TK16-1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No