MedDataX Logo

Comparative Evaluation of Dental Disease Prevention Programs

NCT ID: NCT05767281

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Purpose of the study. Development of a comprehensive program for the prevention of dental caries, periodontal disease based on an analysis of the situation in dentistry.

Research objectives:

1. To study the prevalence and intensity of major dental diseases from 1995 to 2023 according to the WHO methodology (2013);
2. To study the behavioral risk factors for dental diseases in the child population of Chapaevsk according to the WHO methodology (2013);
3. To study the concentration of fluorine ion in the drinking water of municipal water supply and its other sources (bottled water, street vending machines for drinking water, filtered water, etc.);
4. To study the awareness of the population, parents, primary health care personnel, educators, teachers about the risk factors for chronic non-communicable diseases (arterial hypertension, cardiovascular diseases, diabetes mellitus, etc.) and their prevention;
5. To study the features of urinary fluoride excretion in preschool children in order to justify the safety of using fluorides to prevent caries;
6. Conduct an analysis of the situation in dentistry and develop a comprehensive program for the prevention of dental morbidity for the child population;
7. To study in a pilot project the effectiveness of the developed program for the prevention of major dental diseases.

Materials and research methods.

1. Epidemiological studies according to WHO (2013) - 1000 people (3, 5-6, 7 years old, 12, 15, 18 years old) with the WHO questionnaire (parents of children aged 3, 5-6, 7 years and children 12, 15 , 18 years old (1000 people)).
2. Determination of fluorides in public water supply, individual households, bottled water and urine using an F-selective electrode (Mettler Toledo).
3. Determination of F ions before filtration and after filtration of water using household filters.
4. Marketing studies of hygiene products (toothpastes, additional oral hygiene products), in pharmaceutical institutions, markets and markets)
5. Studying the effectiveness of the implemented prevention program by blind control after 3 months, 6 months, 1 year, 1.5 years, 2 years.
6. Statistical analysis of the effectiveness of the prevention program in the pilot project.

Scientific novelty.

* risk factors affecting the dental health of children will be identified;
* a comprehensive program for the prevention of the child population will be developed, taking into account the analysis of the situation in dentistry;
* the need and safety of the use of fluorides for the prevention of dental caries will be justified (based on the study of the proportion of fluorides excreted by the kidneys and the analysis of the intensity of dental caries.

Practical significance.

1. During the study, the timing of the eruption of permanent teeth will be established;
2. Recommendations will be developed to improve the quality and accessibility of dental care;
3. The importance of monitoring fluoride in drinking water and the daily total intake of fluoride in the body of children will be proved by studying the proportion of fluoride excreted by the kidneys to justify safety;
4. The introduction of the developed prevention program will improve the dental health of children;
5. The need for interdisciplinary and interdepartmental interaction to improve the dental health of children will be substantiated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carious and Non-carious Lesions of the Teeth

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Children 3 years old

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

prevention program

Intervention Type BEHAVIORAL

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 5-6 years old

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

prevention program

Intervention Type BEHAVIORAL

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 7 years old

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

prevention program

Intervention Type BEHAVIORAL

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 old

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

prevention program

Intervention Type BEHAVIORAL

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.

Teenagers 15 years old

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

prevention program

Intervention Type BEHAVIORAL

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.

Teenagers 18 years old

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

prevention program

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prevention program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samara State Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Liliya

Samara, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13

Identifier Type: -

Identifier Source: org_study_id