Clinical trial NCT05767281: Comparative Evaluation of Dental Disease Prevention Programs
Official title: Comparative Evaluation of Comprehensive Programs for the Prevention of Dental Diseases for the Children's Population of Chapaevsk
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carious and Non-carious Lesions of the Teeth
Keywords: ecology;
children caries;
periodontal diseases;
epidemiology;
prevalence of caries;
intensity of caries.
Lead sponsor: Samara State Medical University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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).

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Index of DMF
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: Liliya
Study officials:
References: