Effectiveness of SDF with Injectable Glass Ionomer Cement (SMART technique) in Arresting Early Carious Lesions Among Rural School Children: Mixed-methods implementation research.

The project titled Effectiveness of SDF with Injectable Glass Ionomer Cement (SMART technique) in Arresting Early Carious Lesions Among Rural School Children- Mixed-methods Implementation Research focuses on evaluating a minimally invasive and field-applicable method for managing dental caries among rural school children.

 Introduction-

Dental caries is the most prevalent childhood disease globally, responsible for 3.5 million disability-adjusted life years, and affects nearly 30% of school-age children and 50% of the rural population. Schools offer an ideal setting to deliver preventive care in underserved areas. The Atraumatic Restorative Treatment (ART) is a minimally invasive, anxiety-free approach well suited for such environments. Another effective caries management method, Silver Diamine Fluoride (SDF), enhances mineral density by forming fluorohydroxyapatite. However, traditional powder-liquid Glass Ionomer Cement (GIC) used in ART faces challenges related to isolation, handling, and operator variability. This study proposes the use of injectable resin-based GIC combined with SDF (SMART technique) to improve mechanical strength, ease of handling, and caries prevention while retaining fluoride benefits.

 Aim and Objectives-

The main aim is to evaluate the effectiveness of Silver-modified Injectable Glass Ionomer Cement in arresting early carious lesions among rural school children. The primary objective is to assess the field effectiveness of the SMART technique in caries arrest over 12 months. The secondary objectives are to evaluate clinical performance using the modified USPHS scale, assess children’s acceptability using a Likert scale based on chewing improvement, and identify barriers and facilitators influencing community implementation.

 Novelty-

In resource-limited settings, tooth-preserving point-of-care treatments must be affordable and simple. Injectable resin-based GICs provide greater strength, fewer voids, and easy manipulation. The trial will proceed in three phases- comparison of SDF and injectable GIC versus GIC alone; assessment of children’s acceptability using a Likert scale; and qualitative analysis through interviews of operators.

 Relevance to Public Health-

ART, a component of the WHO Basic Package of Oral Care, provides minimally invasive treatment in underserved areas. With nearly 69% of India’s population residing in rural regions and limited dentist availability, scalable and low-cost techniques like SMART are crucial for improving oral health and service utilisation.

 Relative Importance and Research Gap-

SMART addresses the limitations of conventional GIC restorations by merging the benefits of SDF with injectable GIC for improved outcomes. Implementation research on rural oral health delivery remains limited; this project bridges that gap by evaluating a low-cost, minimally invasive, and community-adapted model.

 Applicability-

In the short term, the project will enhance affordable oral healthcare delivery in schools. In the long term, it aims to reduce caries burden, improve oral health-related quality of life, and provide implementation insights for policymakers and clinicians.

 Methodology-

A pragmatic field trial will be conducted in rural school camps following Proctor’s Implementation Outcomes Framework and qualitative exploration using CFIR. The study will include children aged 3 to 11 years with carious primary molars.

 Intervention- SDF combined with injectable resin-based GIC (light curable)

Primary outcomes- Caries arrest, restoration retention, marginal integrity, colour match, postoperative sensitivity, and form (USPHS criteria)

Duration- 12 months, with evaluations at 6 and 12 months

Design- Single-arm pre- and post-comparison study

Clinical procedures will follow ART guidelines.

 Inclusion and Exclusion Criteria-

Inclusion criteria include carious primary molars (ICDAS 2–4) without pulpal involvement, accessible by spoon excavator, and children with positive behaviour. Exclusion criteria include multisurface or pulp-involving caries, unrestorable teeth, and silver allergy.

 Sample Size and Sampling-

The quantitative sample size was calculated assuming a 95% success rate for the new methodology. Considering an expected response rate of 80%, the study requires a total sample size of 92 participants to estimate the expected proportion with 5% absolute precision at a 95% confidence level. For the qualitative component, three operators will be interviewed, and all treated children will be assessed for acceptability.

 Sampling will follow a multistage multiphase approach across Andhra Pradesh, involving selection of districts, mandals, wards, and schools with at least 250 children for representativeness.

 Study Tools and Variables-

Caries will be classified using ICDAS, restoration performance evaluated by modified USPHS, and caries burden assessed using dmft/dmfs indices. Independent variables include intervention type (SDF plus injectable GIC), baseline caries status, oral hygiene maintenance, and lesion characteristics. Dependent variables include caries arrest rate, restoration retention, treatment acceptability, barriers, cost, and time.

 Data Collection and Analysis-

Data will be collected through direct observation and recorded using standard clinical scales. Descriptive statistics will summarise continuous variables as mean and standard deviation or median and interquartile range, and categorical variables as frequencies and percentages. Inferential statistics will include paired t-test or Wilcoxon signed-rank test for continuous variables, and Chi-square or Fisher’s exact test for categorical variables, with significance set at p < 0.05 (IBM SPSS). Qualitative data will undergo deductive and inductive coding based on CFIR, followed by content analysis using Atlas.ti.

 This mixed-methods project aims to establish a clinically effective, affordable, and socially viable caries management model suited for rural community-based oral health programs.