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.
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
- Conditions the study is for
- Carious and Non-carious Lesions of the Teeth
- What is being tested?
- prevention program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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
- Are there results?
- None posted in the registry
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.
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.
Read more
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:
- To study the prevalence and intensity of major dental diseases from 1995 to 2023 according to the WHO methodology (2013);
- To study the behavioral risk factors for dental diseases in the child population of Chapaevsk according to the WHO methodology (2013);
- 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.);
- 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;
- To study the features of urinary fluoride excretion in preschool children in order to justify the safety of using fluorides to prevent caries;
- Conduct an analysis of the situation in dentistry and develop a comprehensive program for the prevention of dental morbidity for the child population;
- To study in a pilot project the effectiveness of the developed program for the prevention of major dental diseases.
Materials and research methods.
- 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)).
- Determination of fluorides in public water supply, individual households, bottled water and urine using an F-selective electrode (Mettler Toledo).
- Determination of F ions before filtration and after filtration of water using household filters.
- Marketing studies of hygiene products (toothpastes, additional oral hygiene products), in pharmaceutical institutions, markets and markets)
- Studying the effectiveness of the implemented prevention program by blind control after 3 months, 6 months, 1 year, 1.5 years, 2 years.
- 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.
- During the study, the timing of the eruption of permanent teeth will be established;
- Recommendations will be developed to improve the quality and accessibility of dental care;
- 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;
- The introduction of the developed prevention program will improve the dental health of children;
- 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 group | Role | What they receive |
|---|---|---|
| Children 3 years old | Epidemiological 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 old | Epidemiological examination of children according to the WHO 2013 methodology, including only an examination of the oral cavity. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted14 Mar 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious and Non-carious Lesions of the TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Comprehensive Programs for the Prevention of Dental Diseases for the Children's Population of Chapaevsk
- ClinicalTrials.gov ID
- NCT05767281
- Acronym / sponsor ID
- 13
- Keywords
- ecology;, children caries;, periodontal diseases;, epidemiology;, prevalence of caries;, intensity of caries.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To study the prevalence and intensity of major dental diseases from 1995 to 2023 according to the WHO methodology (2013);
- To study the behavioral risk factors for dental diseases in the child population of Chapaevsk according to the WHO methodology (2013);
- 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.);
- 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;
- To study the features of urinary fluoride excretion in preschool children in order to justify the safety of using fluorides to prevent caries;
- Conduct an analysis of the situation in dentistry and develop a comprehensive program for the prevention of dental morbidity for the child population;
- To study in a pilot project the effectiveness of the developed program for the prevention of major dental diseases.
Materials and research methods.
- 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)).
- Determination of fluorides in public water supply, individual households, bottled water and urine using an F-selective electrode (Mettler Toledo).
- Determination of F ions before filtration and after filtration of water using household filters.
- Marketing studies of hygiene products (toothpastes, additional oral hygiene products), in pharmaceutical institutions, markets and markets)
- Studying the effectiveness of the implemented prevention program by blind control after 3 months, 6 months, 1 year, 1.5 years, 2 years.
- 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.
- During the study, the timing of the eruption of permanent teeth will be established;
- Recommendations will be developed to improve the quality and accessibility of dental care;
- 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;
- The introduction of the developed prevention program will improve the dental health of children;
- The need for interdisciplinary and interdepartmental interaction to improve the dental health of children will be substantiated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Children 3 years old | – | Behavioral: prevention programEpidemiological examination of children according to the WHO 2013 methodology, including only an examination of the oral cavity. |
| Children 5-6 years old | – | Behavioral: prevention programEpidemiological examination of children according to the WHO 2013 methodology, including only an examination of the oral cavity. |
| Children 7 years old | – | Behavioral: prevention programEpidemiological survey of adolescents according to the WHO 2013 methodology, including only an examination of the oral cavity. |
| Children 12 years old | – | Behavioral: prevention programEpidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire. |
| Teenagers 15 years old | – | Behavioral: prevention programEpidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire. |
| Teenagers 18 years old | – | Behavioral: prevention programEpidemiological survey of adolescents according to the WHO 2013 methodology, including an examination of the oral cavity and a questionnaire. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (1 listed)
- The main age groups of the WHO survey (2013)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prevention programintroduction 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. | Behavioural | Children 12 years old, Children 3 years old, Children 5-6 years old, Children 7 years old, Teenagers 15 years old, Teenagers 18 years old |
Primary outcome
Index of DMF
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carious and Non-carious Lesions of the Teeth, run by Samara State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of DMF (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.