Comparative Evaluation of Dental Disease Prevention Programs

Sponsor
Samara State Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05767281
Collaborator
(none)
1,000
1
40
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: prevention program

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparative Evaluation of Comprehensive Programs for the Prevention of Dental Diseases for the Children's Population of Chapaevsk
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
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
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.

Behavioral: 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.

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
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.

Behavioral: 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.

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
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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Index of DMF [5 minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • The main age groups of the WHO survey (2013)
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Liliya Samara Russian Federation

Sponsors and Collaborators

  • Samara State Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samara State Medical University
ClinicalTrials.gov Identifier:
NCT05767281
Other Study ID Numbers:
  • 13
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Samara State Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023