Epidemiological Investigation of Malocclusion in China

Malocclusion Clinical Trial

Official title:

A Comprehensive Epidemiological Investigation of Malocclusion in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352385
• Other study ID #: SH9H-2024-TK16-1.0
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Chao Liu, PhD
• Phone: 19821231579
• Email: 120116[@]sh9hospital.org.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19847
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	dietary habit	Questionnaire survey	recruitment until December 2026
Other	oral hygiene habits	Questionnaire survey	recruitment until December 2026
Other	Bad oral habit	Questionnaire survey	recruitment until December 2026
Primary	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	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
Secondary	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