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CTRI Number  CTRI/2026/01/100689 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Stopping Early Tooth Decay in Rural Schoolchildren Using the SMART Dental Technique. 
Scientific Title of Study   Effectiveness of SDF with Injectable Glass Ionomer Cement (SMART technique) in Arresting Early Carious Lesions Among Rural School Children: Mixed-methods implementation research. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHERANJEEVI JAYAM 
Designation  ADDITIONAL PROFESSOR 
Affiliation  All India Institute Of Medical Sciences Mangalagiri 
Address  DEPARTMENT OF DENTISTRY ROOM NO 441 4TH FLOOR OPD BUILDING AIIMS MANGALAGIRI GUNTUR DISTRICT ANDHRA PRADESH

Guntur
ANDHRA PRADESH
522503
India 
Phone  8894337313  
Fax    
Email  drjayam.dental@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  CHERANJEEVI JAYAM 
Designation  ADDITIONAL PROFESSOR 
Affiliation  All India Institute Of Medical Sciences Mangalagiri 
Address  DEPARTMENT OF DENTISTRY ROOM NO 441 4TH FLOOR OPD BUILDING AIIMS MANGALAGIRI GUNTUR DISTRICT ANDHRA PRADESH

Guntur
ANDHRA PRADESH
522503
India 
Phone  8894337313  
Fax    
Email  drjayam.dental@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query
 
Name  CHERANJEEVI JAYAM 
Designation  ADDITIONAL PROFESSOR 
Affiliation  All India Institute Of Medical Sciences Mangalagiri 
Address  DEPARTMENT OF DENTISTRY ROOM NO 441 4TH FLOOR OPD BUILDING AIIMS MANGALAGIRI GUNTUR DISTRICT ANDHRA PRADESH

Guntur
ANDHRA PRADESH
522503
India 
Phone  8894337313  
Fax    
Email  drjayam.dental@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Model Rural Health Research Unit  
Address  Model Rural Health Research Unit Indian Council of Medical Research Department of Health Research Ministry of Health and Family Welfare Government of India Chandragiri Tirupati District Andhra Pradesh PIN CODE 517 101.  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR CHERANJEEVI JAYAM  AIIMS MANGALAGIRI  DEPARTMENT OF DENTISTRY, ROOM NO 441, 4TH FLOOR, OPD BUILDING, AIIMS, MANGALAGIRI, GUNTUR DISTRICT, ANDHRA PRADESH.
Guntur
ANDHRA PRADESH 
8894337313

drjayam.dental@aiimsmangalagiri.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS MANGALAGIRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  SDF application plus Injectable resin-based Glass Ionomer cement  Silver Diamine Fluoride application plus Injectable resin-based Glass Ionomer cement 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  1. Carious deciduous first and second molars
2. At least one carious lesion – ICDAS score – 2-4
3. Lesion must be cavitated but accessible with the small hand spoon excavator
4. No signs of pulpal involvement and periapical pathology
5. Children exhibiting definitely positive or positive behaviour according to
Frankl behaviour scale 
 
ExclusionCriteria 
Details  1. Grossly carious tooth or multisurface restoration
2. Tooth with Multisurface carious lesion
3. Caries approximating pulp or involving pulp
4. Children with known silver allergy
5. Teeth that are unrestorable and structurally compromised tooth 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ICDAS scale score at
Baseline and 12
months; with clinical
evaluation of lesion
colour & texture 
6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Modified USPHS
criteria assessed at 12
months (e.g. marginal
integrity, form,
surface texture, postop
sensitivity) 
6 months and 12 months 
Acceptability among children on a likert scale using post treatment improvements (Perceived improvement in chewing after intervention).  12 months 
In-depth interviews method to explore barriers and Facilitators influencing progam (CFIR)  12 months 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   19/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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