Epidemiological Investigation of Malocclusion in China

NCT06352385 | Not Yet Recruiting

• 1 other identifier: SH9H-2024-TK16-1.0
• Study Type: observational
• Target: 19,847
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epidemiological Investigation; Malocclusion

Outcome Measures

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.

  recruitment until December 2026

Secondary Outcomes (2)

• Dental Aesthetic Index of each age group

  recruitment until December 2026

• Index of Orthodontic Treatment Need of each age group

  recruitment until December 2026

Other Outcomes (3)

• dietary habit

  recruitment until December 2026

• oral hygiene habits

  recruitment until December 2026

• Bad oral habit

  recruitment until December 2026

Study Arms (4)

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.

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bing Fang, PhD

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Liu, PhD

CONTACT

19821231579; 120116@sh9hospital.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 8, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share