Clinical trial NCT06352385: Epidemiological Investigation of Malocclusion in China
Official title: A Comprehensive Epidemiological Investigation of Malocclusion in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epidemiological Investigation
Malocclusion
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 19847
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Prevalence rate of malocclusion
timeFrame: recruitment until December 2026
Secondary outcomes:
measure: Dental Aesthetic Index of each age group
timeFrame: recruitment until December 2026
measure: Index of Orthodontic Treatment Need of each age group
timeFrame: recruitment until December 2026
Other outcomes:
measure: dietary habit
timeFrame: recruitment until December 2026
measure: oral hygiene habits
timeFrame: recruitment until December 2026
measure: Bad oral habit
timeFrame: recruitment until December 2026
Locations:
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Bing Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References: