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Carious and Non-carious Lesions of the TeethNCT05767281

Comparative Evaluation of Dental Disease Prevention Programs

An observational study of Carious and Non-carious Lesions of the Teeth, run by Samara State Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 3 to 17 yearsHealthy volunteers can take part
What is being tested?
prevention program
How many people
1,000 participants
Where
1 siteRussia
Study dates
1 Sep 2022to 31 Dec 2025
How long will I take part?
3 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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).

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • Liliya

    Samara

Other trials in Russia

About this study

Official title: Comparative Evaluation of Comprehensive Programs for the Prevention of Dental Diseases for the Children's Population of Chapaevsk

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.

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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.

Read the 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.
Being tested
prevention program
Keywords
ecology;, children caries;, periodontal diseases;, epidemiology;, prevalence of caries;, intensity of caries.
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prevention programBehavioural

    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.

Study groups in NCT05767281
Study groupRoleWhat they receive
Children 3 years oldEpidemiological examination of children according to the WHO 2013 methodology, including only an examination of the oral cavity.
Receives: Behavioral: prevention program
Children 5-6 years oldEpidemiological examination of children according to the WHO 2013 methodology, including only an examination of the oral cavity.
Receives: Behavioral: prevention program
Children 7 years oldEpidemiological survey of adolescents according to the WHO 2013 methodology, including only an examination of the oral cavity.
Receives: Behavioral: prevention program
Children 12 years oldEpidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire.
Receives: Behavioral: prevention program
Teenagers 15 years oldEpidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire.
Receives: Behavioral: prevention program
Teenagers 18 years oldEpidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire.
Receives: Behavioral: prevention program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start1 Sep 2022
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767281
Sponsor's protocol ID
13
Status last verified
Oct 2026
First submitted
5 Feb 2023
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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