NCT05767281

Brief Summary

Relevance. The dental health of the Chapaevsk children's population and the risk factors for dental caries and periodontal disease were well studied in 1995-2009. But pilot epidemiological studies conducted in 2018 by employees of the Department of Pediatric Dentistry and Orthodontics showed that despite the improvement in the environmental situation as a result of large-scale state measures of the city's environmental rehabilitation program, the prevalence and intensity of dental caries increased against the background of improved somatic health indicators. In addition, the "K" component (untreated caries) prevails in the structure of the KPU, which indicates gaps in the organization of dental care. At present, the development and implementation of a comprehensive program for the prevention of dental diseases, based on an analysis of the situation and aimed at strengthening the health and improving the quality of life of children in Chapaevsk, remains an extremely urgent problem. Such a program can be used for implementation in other regions with the adaptation of measurable prevention targets. Scientific novelty of the research. Identification of risk factors affecting children's dental health, especially regarding the safety of using fluoride to prevent dental caries Development of a comprehensive program for the prevention of the child population, taking into account the analysis of the situation in dentistry in Chapaevsk, with the participation of primary health care personnel, caregivers and families. The practical significance of the study involves the introduction of a developed comprehensive prevention program among the child population, based on interdisciplinary interaction at the level of primary health care and interdepartmental interaction with the teaching staff of preschool educational institutions and schools.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

2.3 years

First QC Date

February 5, 2023

Last Update Submit

December 12, 2024

Conditions

Keywords

ecology;children caries;periodontal diseases;epidemiology;prevalence of caries;intensity of caries.

Outcome Measures

Primary Outcomes (1)

  • Index of DMF

    The decay-missing-filled (DMF) index or decayed, missing, and filled teeth (DMFT) index is one of the most common methods in oral epidemiology for assessing dental caries prevalence as well as dental treatment needs among populations. This index is based on in-field clinical examination of individuals by using a probe, mirror and cotton rolls, and simply counts the number of decayed, missing (due to caries only) and restored teeth. Statistics are available per populations according to age.

    5 minutes

Study Arms (6)

Children 3 years old

Epidemiological examination of children according to the WHO 2013 methodology, including only an examination of the oral cavity.

Behavioral: prevention program

Children 5-6 years old

Epidemiological examination of children according to the WHO 2013 methodology, including only an examination of the oral cavity.

Behavioral: prevention program

Children 7 years old

Epidemiological survey of adolescents according to the WHO 2013 methodology, including only an examination of the oral cavity.

Behavioral: prevention program

Children 12 years old

Epidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire.

Behavioral: prevention program

Teenagers 15 years old

Epidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire.

Behavioral: prevention program

Teenagers 18 years old

Epidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire.

Behavioral: prevention program

Interventions

introduction of the developed comprehensive prevention program among the child population with the participation of primary health care personnel, which will improve not only the dental health of children, their quality of life, but will also help reduce foci of chronic oral sepsis.

Children 12 years oldChildren 3 years oldChildren 5-6 years oldChildren 7 years oldTeenagers 15 years oldTeenagers 18 years old

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Dental examination of children will be carried out in the conditions of school educational institutions after obtaining voluntary informed consent for dental examination from the administration and legal representatives of students. Examination of children will be carried out directly in the classroom using sterile sets of dental instruments (dental and periodontal probes, dental mirrors).

You may qualify if:

  • The main age groups of the WHO survey (2013)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liliya

Samara, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine and oral fluid

MeSH Terms

Conditions

Periodontal Diseases

Interventions

National Program of Cancer Registries

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Centers for Disease Control and Prevention, U.S.United States Public Health ServiceUnited States Dept. of Health and Human ServicesUnited States Government AgenciesFederal GovernmentGovernmentOrganizationsHealth Care Economics and Organizations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

March 14, 2023

Study Start

September 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations