A community-based pragmatic, controlled trial for preventing and reducing oral diseases among 1–6-year-old children visiting Anganwadi centers, under the Integrated Child Development Scheme, India

Early childhood caries (ECC) is a significant public health challenge that has reached epidemic proportions and has affected millions of young children both in developed and developing nations [1‐3]. While considering the potential burden and the morbidity associated with this disease, several policies have been formed and implemented at the international level to decrease the overall burden of the disease across various age groups by setting age-specific targets. A joint group of the World Health Organization (WHO) and the Federation Dentaire Internationale (FDI) proposed the global average for dental caries to be 3 DMFT for 12-year-olds and 50% of 5–6-year-olds to be free of dental caries by 2000 [4]. Prevalence of dental caries is on a decline in many industrialised nations due to their well-structured oral health programs, and a good percentage of their GDP had been directed towards oral health, and the majority of them have achieved these goals. However, the developing nations like India are far from reaching WHO targets due to lack of any national-level policies for prevention and control of dental diseases. The problem is compounded by several factors including the disparity in the distribution of population, with two-thirds of the Indian community residing in rural areas, of which 40% are children [5]. The dramatic improvement in the dentist-population ratio over the past 6–7 decades from 1:301,000 in the 1960s to an average of 1:9992 in 2016 has not equally reflected in the rural and urban areas with the majority being concentrated in the latter (1:4000) and only about 25–30% of them serving in the rural regions (1:30,000); consequentially even necessary oral health facilities are not available in some of the areas [6]. The prevalence of ECC in Indian children less than 5 years ranges between 50 and 70%; the significant sequelae being root stumps warranting extractions and abscesses resulting from pulpal involvement of primary teeth, ultimately affecting the speech, mastication and esthetics of the child [7‐11]. Literature regarding the impact of ECC on the quality of life of children as well as their families reports that despite comprehensive oral rehabilitation of the affected dentition, their quality of life remained significantly lower than that of children who did not develop the disease [12]. Keeping in mind the significant morbidity, loss of school hours in children and substantial finances involved in the treatment of ECC, the only practically viable solution for dealing with ECC is its prevention.

Prevention of ECC can be brought through education of expectant mothers and mothers of young children regarding appropriate oral hygiene measures and dietary practices. In a utopian universe, this task would best be carried out by trained dental professionals. However, the country faces a gross disparity in the regional distribution of the dental health workforce, as mentioned before. A promising alternative workforce for the task seems to be the female workers at the Anganwadi centres (AWC) under the ICDS scheme which was launched in 1975 to provide mid-day meal, pre-school education and primary healthcare to children under 6 years of age. These workers can be used to effectively counsel and deliver the oral health education to both children and mothers’ thus serving as the much-needed initiative at the national level. ICDS scheme is an ideal example of community participation under the Primary Health Care concept (Alma Ata declaration 1978). As of 2015, the number of operational AWCs in India is 1,349,091 with each centre covering a population of 1000 in rural and urban areas and 700 in Tribal regions [13]. Anganwadi workers (AWW) promote and monitor overall child development, carry out additional feeding, immunisation, dispense vitamin A, iron and folic acid tablets and referral to the medical care facility. AWWs also provide outreach services by visiting door-to-door in the community as agents of social change mobilisation for better care of young children, girls and women. Though adequately trained on issues concerning general health, various studies have cited limited oral health knowledge and awareness among them [14, 15]. Nevertheless, they appear to be a potential health workforce that is yet to be utilised for controlling and limiting many prevalent oral diseases like ECC in India.

A one-year pilot project funded by the Department of Science and Technology, Government of India (2014–15), was carried out to develop an oral health care package for prevention and control of oral diseases among mothers and pre-school children, and to test whether AWWs could be utilised for delivering this package.

The present research project aims to compare the effect of the above tested oral health care package versus routine dental care advice generally imparted by the AWWs on change in dental caries, gingival health and S mutans levels among 1 to 6-year-old children and KAP regarding oral health among their mothers at AWCs. The study shall be simultaneously carried out at two geographically distant sites; peri-urban areas of Chandigarh and rural parts of Cuttack, Orissa. In contrast to Chandigarh, rural Cuttack has got a significant proportion of the tribal population with differing socio-economic, cultural background and dietary habits etc. Keeping two sites in the study shall also additionally permit comparison of study outcomes between these two different populations [16, 17].

Although ECC has been recognised as a disease with widespread prevalence and implications but still a practical approach to manage it is far from reality. There is no scientific evidence for prevention of ECC based on a single method or to favour one approach over another [19, 20]. Hence, whole-population strategies that would disseminate information on ECC and its prevention based on current etiological paradigms of this disease are required. For obvious reasons, this dissemination should occur through the existing resources without putting any extra financial burden over the limited health resources present in developing countries. The Anganwadi workforce in India or similar primary health care setups can efficiently be utilised to implement preventive and promotive protocols to safeguard growth and development of young children. Oral disease, predominantly ECC, in young children can be prevented to a great extent if AWCs are sufficiently empowered, and the workers sensitised, educated & motivated and made responsible for educating and motivating mothers to provide the best oral care for their children [21].

Nonetheless, of the high prevalence of ECC and below-average to moderate and satisfactory knowledge of oral health among AWWs, oral health has not been included in the training package of the AWWs nationally [15]. The limited oral health-related knowledge of the AWWs would be kept in mind while designing the training module and the oral health promotion training material for the AWWs. It is expected that the AWWs’ motivation, manifested in their behaviour in the workplace, shall significantly affect the outcome of the present study. Therefore, motivation and reinforcement sessions have been kept every three months for the AWWs throughout the intervention phase of three years. AWWs remuneration pattern is honorarium based; hence, suitable honorarium shall also be given to them every month to maintain their interest in the program.

ECC prevention had conventionally focused upon testing effectiveness of programs targeting behaviour change among the caregivers and children, but surprisingly minimal efforts have had been made to seek translation of these efforts into the reduction of ECC at the community level. The present study shall simultaneously carry with it both the components, i.e. testing effect of altering maternal and child behavioral aspects on ECC incidence through Cohort follow up of 1–3-year-old children for three consecutive years and also a cross-sectional follow up of all available 1–6-year old children at the selected AWCs at regular intervals to look for any change in prevalence of ECC at community level. In other regions of the world surveys of ECC prevalence before and after the intensive educational programs have shown a significant reduction in ECC prevalence [22‐27]. A similar decline can be anticipated through this program as well.

Many times, habits and behaviours are so deeply established that it becomes challenging and impractical to change them through health education. Hence, feasibility and effectiveness of delivering new approaches that are not based upon subject compliance or which specifically target behaviour change should also be evaluated. Results from professional tooth brushing programs or professional administration of topical antimicrobial agents and fluoride are ambiguous, and feasibility of any such application at large in community settings had not been discussed. The focus of the current program will be to share responsibility for caries prevention between both dental professionals and parents [1, 28‐30]. Hence, in addition to educating mothers regarding occurrence and prevention of ECC, feasibility and effectiveness of the professional application of 2.26% fluoride varnish and 10% povidone-iodine in field setup shall also be assessed. Only a very few randomised clinical trials with smaller samples and shorter follow up duration have determined the effect of the application of these topical agents on ECC [18, 30‐32]. Hence, the present study shall be a controlled trial that would comprehensively take into account the maternal factors (oral health education through trained AWWs and Behavior Change Communication material) and directly limiting the cariogenic bacterial count in children through professional application of 2.26% fluoride varnish and 10% Povidone-iodine. The study is also unique in terms of being amongst a very few multi-level trials with a human-centred approach to deliver oral health intervention indeed at primordial and primary level and to reduce oral diseases among pre-school children in both peri-urban and rural settings. A real-time data entry and sharing software shall be developed, and this will help in effective monitoring of the study as well. Upscaling of the project can be done to other AWCs of the country if the present approach is found to be effective and practical.