Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441500
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-19
Brief Title:
Oral Health and Dental Caries Prevention Intervention for Children in Romania
Sponsor:
University of Medicine and Pharmacy Victor Babes Timisoara
Organization:
University of Medicine and Pharmacy Victor Babes Timisoara
Study Overview
Official Title:
Child Oral Health Pilot Programme - SmilebrightRO
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Smilebright
Brief Summary:
During 2019-2020 the National Oral Health Survey evaluated a significant sample of children aged 5 6 and 12 years gathering baseline data on oral health Data was used to estimate the distribution and severity of dental caries the need for community-oriented disease prevention and health promotion and the nature of oral health interventions required The survey also established how younger age groups can be reached and evaluated Only 14 of 6 years old children have dmft 0 and the SiC index of the same sample is 983 High prevalence of tooth decay with high severity scores significant inequalities in oral health and poor use and access to services showed the need for a child oral health programme
The originality of the project lies in the vision of using fluoridated toothpaste not only as a means of preventing new carious lesions but also in the therapeutic effect of fluoridated toothpaste which the study set out to evaluate This programme could represent an example of good practice for the countries in our region starting from downstream oral health interventions such as clinical prevention and oral health promotion and developing towards upstream interventions
The aim of the project is to improve oral health and reduce inequalities both in dental health and access to dental services by shifting the balance of care towards preventive care
The programme is structured on three levels
1 Specific training for dental hygienists to deliver oral health promotion to children and nursery educators focus on tailoring key messages outlined in the care pathway and practical preparation for delivering interventions in nurseries
2 A toothpastetoothbrushing scheme involving free daily toothbrushing to every 3 and 4-year old child attending nursery
3 Provision of clinical prevention activities delivered by dental hygienists for children attending nurseries
The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children Due to the fact that it is a pilot programme aiming to be further implemented at national level an evolving model of evaluation is appropriate This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings
The originality of the project lies in the vision of using fluoridated toothpaste not only as a means of preventing new carious lesions but also in the therapeutic effect of fluoridated toothpaste which the study set out to evaluate This programme could represent an example of good practice for the countries in our region starting from downstream oral health interventions such as clinical prevention and oral health promotion and developing towards upstream interventions
The aim of the project is to improve oral health and reduce inequalities both in dental health and access to dental services by shifting the balance of care towards preventive care
The programme is structured on three levels
1 Specific training for dental hygienists to deliver oral health promotion to children and nursery educators focus on tailoring key messages outlined in the care pathway and practical preparation for delivering interventions in nurseries
2 A toothpastetoothbrushing scheme involving free daily toothbrushing to every 3 and 4-year old child attending nursery
3 Provision of clinical prevention activities delivered by dental hygienists for children attending nurseries
The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children Due to the fact that it is a pilot programme aiming to be further implemented at national level an evolving model of evaluation is appropriate This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings
Detailed Description:
Until recently Romania has lacked baseline data regarding the oral health status of children A previous study by Petersen et al was conducted in the 1990s covering only five major cities and without taking into account rural areas Some local papers described a high caries prevalence Only one longitudinal study assesses caries trends in Romanian schoolchildren A contemporary assessment was therefore mandatory in order to advance scientific understanding and allow for the development of adequate public health policies During 2019-2020 the National Oral Health Survey financed by The Borrow Foundation evaluated a significant sample of children aged 5 6 and 12 years gathering baseline data on oral health according to the WHO guidelines The data was used to estimate the distribution and severity of dental caries the need for community-oriented disease prevention and health promotion and the nature and urgency of the oral health interventions required The survey also established how younger age groups can be reached and evaluated Unpublished data show that only 14 of 6 years old children have dmft 0 and the SiC index of the same sample is 983 High prevalence of tooth decay with high severity scores significant inequalities in oral health and poor use and access to services showed the need for a child oral health programme
The main objectives of the program are to
1 Reorient the traditional curative approach which is basically pathogenic and move towards a preventive promotional approach
2 Strengthen cross-sectoral collaboration across key settings such as schools communities and workplaces to promote habits and healthy lifestyles integrating teachers and the family
3 Raising the priority accorded to the prevention and control of oral diseases in regional and national agendas and development goals through strengthened cooperation and advocacy
The programme is designed to deliver additional clinical prevention activities through dental hygienists aimed at children aged three years and above attending priority nursery establishments in order to improve oral health of young children and complemented the established national toothpastetoothbrushing scheme
The programme will be implemented for a period of 24 months under guidance from the WHO Collaborative Centre for Epidemiology and Community Dentistry Milan Italy Consent from the national and regional authorities will be obtained nurseries will be informed and the informed consent of the parents will be asked The total sample size will be calculated according to the WHO guidelines using a stratified sampling technique for examination sites in Bucharest Timisoara Cluj-Napoca Craiova Iasi Targu Mures and the surrounding geographical area The programme will be conducted in collaboration with the Universities of Medicine in the capital and the cities mentioned above under supervision of the university staff Data collection points will be 4 kindergartens in the Capital or metropolitan areas 2 kindergartens in each of 2 large cities and 1 kindergarten in each 4 villages from different geographic areas
The programme fits in the Oral Health Resolution of the Seventy-fourth World Health Assembly WHA 745 - 31052021 aiming at
understanding and addressing the key risk factors for poor oral health and associated burden of disease
fostering the integration of oral health within their national policies including through the promotion of articulated interministerial and intersectoral work
reorienting the traditional curative approach which is basically pathogenic and move towards a preventive promotional approach with risk identification for timely comprehensive and inclusive care
strengthen cross-sectoral collaboration across key settings such as schools communities and workplaces to promote habits and healthy lifestyles integrating teachers and the family The study design takes into consideration all principles stated in the WHO Implementation Manual Ending childhood caries Early diagnosis of caries lesions through clinical examinations in the nurseries control of risk factors trough the evaluation of oral health related knowledge and behaviours and health education arresting caries through the application of fluoride varnishes developing primary care teams by introducing a new workforce - dental hygienists building a framework to integrate prevention and control of dental caries into general health interventions
The project will be implemented in collaboration with the universities of Medicine and Pharmacy in the country to ensure a homogeneous distribution of evaluation sites Selection of nurseries will be done according to the pathfinder sampling technique This survey design is suitable for collection of data for planning purposes and monitoring of oral health programmes in all countries regardless of the level of disease availability of resources or complexity of care The principles of the sampling techniques are the following
The study supposes a sample of 460 children
There are 6 universities involved in data collection
Data will be collected from 3 types of residential areas metropolitan areas 180 evaluations big cities 180 evaluations rural areas 100 evaluations
In metropolitan areas and big cities 25 children have to be evaluated in the same kindergarten
In rural areas more than one kindergarten can be evaluated until the desired number of evaluations is obtained for the specific region This principle has been added because kindergarten is not mandatory in Romania and the number of children enrolled in kindergarten in rural areas is quite low in some regions of the country
Distribution of data collection points
University of Medicine and Pharmacy Bucharest will provide
25 evaluations in one kindergarten in Bucharest
25 evaluations in rural areas of surrounding counties
University of Medicine and Pharmacy Cluj will provide
25 evaluations in one kindergarten in Cluj Napoca
25 evaluations in rural areas of surrounding counties
University of Medicine and Pharmacy Craiova will provide
25 evaluations in 2 kindergartens in Drobeta-Turnu Severin
25 in rural areas of surrounding counties
University of Medicine and Pharmacy Iași will provide
25 evaluations in 2 kindergartens in Iași 2 X 25 50
25 in rural areas of surrounding counties
University of Medicine and Pharmacy Targu Mures will provide
25 evaluations in one kindergarten in Targu Mures
25 evaluations Miercurea Ciuc
University of Medicine and Pharmacy Timișoara will provide
25 evaluations in one kindergarten in Timișoara
25 evaluations in 2 kindergartens in Arad According to the WHO STEPS approach results from the first two steps - self-evaluation and collection of clinical data will be used to plan and evaluate further health interventions
Volunteer dental hygienists students will be trained deliver oral health promotion to nursery educators and oral health promotion activities for children focusing on tailoring of key messages to the specific age and on practical preparation for delivering interventions in the nurseries along with implementing the toothpastetooth brushing scheme involving free daily tooth brushing to every 3 and 4-year old child attending nursery
The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children Due to the fact that it is a pilot programme aiming to be further implemented at national level an evolving model of evaluation is appropriate This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings
Methods used in the evaluation have to be formative - to adapt the programme and summative - to assess its impact Evaluation activity includes the collection of routine monitoring data linked with national data sets from the previous survey assessment of the programmes impact at different time-intervals and assessment of economical outcomes
One of the outcomes will be to assess oral health practices of children using the previously designed questionnaire from the National Oral Health Survey meaning to describe oral health behaviour of the evaluated children in correlation to the County Development Index residential area type of residence characteristics of the parents education working status and characteristics of the child age gender The County Developmental Index is a sociological index that combines county-level variables education stock life expectancy at birth medium age of adult population average living space number of private cars to 1000 inhabitants and average household gas consumption Another secondary outcome will establish correlations between the levels of oral health knowledge and clinically detected oral health status and assess the impact of the intervention on the oral and general health status
Monitoring the quality of the intervention delivered by dental hygienist students will assure the necessary information to changeadapt their education to the necessary actions
Short term outcomes will be
Increased level of knowledge and improved oral health behaviours for children in this age group
Reduced risk of new carious lesions and progression of existing lesions
Improved skills of a new profession - dental hygienists and shift of workforce
Improvement of the existing data base and implementation of a monitoring activity at national level
Other potential outcomes
Improved knowledge and behaviour within the families which might lead to an improvement of oral but also general health status
Reduced inequalities in oral health care
Reduced treatment needs and therefore reduced costs for dental treatment The research team proposed to incorporate sustainability into the process taking into account the fact that health interventions often include a number of unquantifiable variables which add a layer of complexity in terms of environmental appraisals The discrepancy between the existence of evidence-based health promotion interventions and their use in practice is present in almost all medical fields but has been widely recognized as a challenge in dentistry Clearly the traditional modes of spreading information through scientific publication channels and passive instruction are not sufficient to reliably initiate and sustain new practices In order to move evidence-based approaches into practice more careful examinations of methods to introduce and sustain effective oral health practices are needed For this project we suggested a framework multi-staged approach This resource is designed to interweave with the many other point of the project that have been developed to guide oral health professionals and dental organizations
The main objectives of the program are to
1 Reorient the traditional curative approach which is basically pathogenic and move towards a preventive promotional approach
2 Strengthen cross-sectoral collaboration across key settings such as schools communities and workplaces to promote habits and healthy lifestyles integrating teachers and the family
3 Raising the priority accorded to the prevention and control of oral diseases in regional and national agendas and development goals through strengthened cooperation and advocacy
The programme is designed to deliver additional clinical prevention activities through dental hygienists aimed at children aged three years and above attending priority nursery establishments in order to improve oral health of young children and complemented the established national toothpastetoothbrushing scheme
The programme will be implemented for a period of 24 months under guidance from the WHO Collaborative Centre for Epidemiology and Community Dentistry Milan Italy Consent from the national and regional authorities will be obtained nurseries will be informed and the informed consent of the parents will be asked The total sample size will be calculated according to the WHO guidelines using a stratified sampling technique for examination sites in Bucharest Timisoara Cluj-Napoca Craiova Iasi Targu Mures and the surrounding geographical area The programme will be conducted in collaboration with the Universities of Medicine in the capital and the cities mentioned above under supervision of the university staff Data collection points will be 4 kindergartens in the Capital or metropolitan areas 2 kindergartens in each of 2 large cities and 1 kindergarten in each 4 villages from different geographic areas
The programme fits in the Oral Health Resolution of the Seventy-fourth World Health Assembly WHA 745 - 31052021 aiming at
understanding and addressing the key risk factors for poor oral health and associated burden of disease
fostering the integration of oral health within their national policies including through the promotion of articulated interministerial and intersectoral work
reorienting the traditional curative approach which is basically pathogenic and move towards a preventive promotional approach with risk identification for timely comprehensive and inclusive care
strengthen cross-sectoral collaboration across key settings such as schools communities and workplaces to promote habits and healthy lifestyles integrating teachers and the family The study design takes into consideration all principles stated in the WHO Implementation Manual Ending childhood caries Early diagnosis of caries lesions through clinical examinations in the nurseries control of risk factors trough the evaluation of oral health related knowledge and behaviours and health education arresting caries through the application of fluoride varnishes developing primary care teams by introducing a new workforce - dental hygienists building a framework to integrate prevention and control of dental caries into general health interventions
The project will be implemented in collaboration with the universities of Medicine and Pharmacy in the country to ensure a homogeneous distribution of evaluation sites Selection of nurseries will be done according to the pathfinder sampling technique This survey design is suitable for collection of data for planning purposes and monitoring of oral health programmes in all countries regardless of the level of disease availability of resources or complexity of care The principles of the sampling techniques are the following
The study supposes a sample of 460 children
There are 6 universities involved in data collection
Data will be collected from 3 types of residential areas metropolitan areas 180 evaluations big cities 180 evaluations rural areas 100 evaluations
In metropolitan areas and big cities 25 children have to be evaluated in the same kindergarten
In rural areas more than one kindergarten can be evaluated until the desired number of evaluations is obtained for the specific region This principle has been added because kindergarten is not mandatory in Romania and the number of children enrolled in kindergarten in rural areas is quite low in some regions of the country
Distribution of data collection points
University of Medicine and Pharmacy Bucharest will provide
25 evaluations in one kindergarten in Bucharest
25 evaluations in rural areas of surrounding counties
University of Medicine and Pharmacy Cluj will provide
25 evaluations in one kindergarten in Cluj Napoca
25 evaluations in rural areas of surrounding counties
University of Medicine and Pharmacy Craiova will provide
25 evaluations in 2 kindergartens in Drobeta-Turnu Severin
25 in rural areas of surrounding counties
University of Medicine and Pharmacy Iași will provide
25 evaluations in 2 kindergartens in Iași 2 X 25 50
25 in rural areas of surrounding counties
University of Medicine and Pharmacy Targu Mures will provide
25 evaluations in one kindergarten in Targu Mures
25 evaluations Miercurea Ciuc
University of Medicine and Pharmacy Timișoara will provide
25 evaluations in one kindergarten in Timișoara
25 evaluations in 2 kindergartens in Arad According to the WHO STEPS approach results from the first two steps - self-evaluation and collection of clinical data will be used to plan and evaluate further health interventions
Volunteer dental hygienists students will be trained deliver oral health promotion to nursery educators and oral health promotion activities for children focusing on tailoring of key messages to the specific age and on practical preparation for delivering interventions in the nurseries along with implementing the toothpastetooth brushing scheme involving free daily tooth brushing to every 3 and 4-year old child attending nursery
The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children Due to the fact that it is a pilot programme aiming to be further implemented at national level an evolving model of evaluation is appropriate This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings
Methods used in the evaluation have to be formative - to adapt the programme and summative - to assess its impact Evaluation activity includes the collection of routine monitoring data linked with national data sets from the previous survey assessment of the programmes impact at different time-intervals and assessment of economical outcomes
One of the outcomes will be to assess oral health practices of children using the previously designed questionnaire from the National Oral Health Survey meaning to describe oral health behaviour of the evaluated children in correlation to the County Development Index residential area type of residence characteristics of the parents education working status and characteristics of the child age gender The County Developmental Index is a sociological index that combines county-level variables education stock life expectancy at birth medium age of adult population average living space number of private cars to 1000 inhabitants and average household gas consumption Another secondary outcome will establish correlations between the levels of oral health knowledge and clinically detected oral health status and assess the impact of the intervention on the oral and general health status
Monitoring the quality of the intervention delivered by dental hygienist students will assure the necessary information to changeadapt their education to the necessary actions
Short term outcomes will be
Increased level of knowledge and improved oral health behaviours for children in this age group
Reduced risk of new carious lesions and progression of existing lesions
Improved skills of a new profession - dental hygienists and shift of workforce
Improvement of the existing data base and implementation of a monitoring activity at national level
Other potential outcomes
Improved knowledge and behaviour within the families which might lead to an improvement of oral but also general health status
Reduced inequalities in oral health care
Reduced treatment needs and therefore reduced costs for dental treatment The research team proposed to incorporate sustainability into the process taking into account the fact that health interventions often include a number of unquantifiable variables which add a layer of complexity in terms of environmental appraisals The discrepancy between the existence of evidence-based health promotion interventions and their use in practice is present in almost all medical fields but has been widely recognized as a challenge in dentistry Clearly the traditional modes of spreading information through scientific publication channels and passive instruction are not sufficient to reliably initiate and sustain new practices In order to move evidence-based approaches into practice more careful examinations of methods to introduce and sustain effective oral health practices are needed For this project we suggested a framework multi-staged approach This resource is designed to interweave with the many other point of the project that have been developed to guide oral health professionals and dental organizations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None