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CTRI Number  CTRI/2025/07/092031 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 25/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   early childhood caries in children aged between 48 to 71 months in district Hapur, Uttar Pradesh 
Scientific Title of Study   Prevalence and predictors of ECC (Early childhood caries in children aged between 48 to 71 months in district Hapur, Uttar Pradesh : An epidemiological study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mudang Moniya 
Designation  PG Student 
Affiliation  Shree Bankey Bihari Dental College 
Address  Department of Pediatrics & Preventive Dentistry ROOM 401, 3RD Floor Masuri Canal

Ghaziabad
UTTAR PRADESH
251015
India 
Phone  08798956053  
Fax    
Email  moniyamudang97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manvi Malik 
Designation  professor & Head 
Affiliation  Shree Bankey Bihari Dental College 
Address  Department of Pediatrics & Preventive Dentistry ROOM 401, 3RD Floor Masuri Canal

Ghaziabad
UTTAR PRADESH
251015
India 
Phone  08798956053  
Fax    
Email  dr.manvimalik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mudang Moniya 
Designation  PG Student 
Affiliation  Shree Bankey Bihari Dental College 
Address  Department of Pediatrics & Preventive Dentistry ROOM 401, 3RD Floor Masuri Canal

Ghaziabad
UTTAR PRADESH
251015
India 
Phone  08798956053  
Fax    
Email  moniyamudang97@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mudang Moniya 
Address  Shree bankey bihari dental college Room 401, 3rd floor, Masuri Canal, Ghaziabad Pin Code - 201015 
Type of Sponsor  Other [self] 
 
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 Mudang Moniya  Shree Bankey Bihari Dental College & Research Centre  Department of Pediatrics & Preventive Dentistry ROOM 401, 3RD Floor Masuri Canal
Ghaziabad
UTTAR PRADESH 
08798956053

moniyamudang97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of Shree Bankey Bihari Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Children studying in urban and rural schools in Hapur district
2.Children in age group of 4 - 6 years
3.Children with consent  
 
ExclusionCriteria 
Details  1. Patient whose parents are not willing to participate
2. Children absent on the day of examination
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of ECC among children in Hapur District  on the day of examinaton 
 
Secondary Outcome  
Outcome  TimePoints 
prevelance of ECC in urban & rural population & their co relation with pedictors of ECC  on the day of examination 
 
Target Sample Size   Total Sample Size="2500"
Sample Size from India="2500" 
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   N/A 
Date of First Enrollment (India)   13/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The growing prevalence of Early Childhood Caries (ECC) pose a major global oral health issue. Oral Health Status Report (2022) highlighted that 514 million children experience caries in their primary teeth. In 2019, the WHO declared dental caries a major public health concern. In India, ECC is  highly prevalent, with around 80% of children affected, and 54.16% of children aged 3 to 18 months suffering from caries. ECC affects 49.6% of preschool children, with rates ranging from 43.8% to 62.3% depending on the region. 

ECC, which impacts primary teeth in children under 71 months, can lead to pain, malnutrition, and an increased risk of permanent tooth decay. ECC is influenced by factors such as genetics, diet, oral hygiene, and cariogenic bacteria. It is strongly associated with future caries in permanent teeth, with varying global prevalence rates. In India, Preventive strategies like fluoride toothpaste, fluoride supplements, water fluoridation and early dental visits are essential in reducing ECC risk.

Despite effective prevention methods, challenges remain due to limited resources for treatment. To improve public health strategies, accurate prevalence data is needed, especially in areas like Hapur, Uttar Pradesh, where limited research exists. The present study aims to assess ECC prevalence in Hapur’s school children and explore determinats such as dental hygiene, socioeconomic status, and fluoride exposure to inform local preventive measures.

 

The study aimed to assess prevalence of ECC among 2,500 school-aged children (aged 4 to 6 years) attending both government and private schools in urban and rural areas of Hapur District. The approval was obtained from Institutional Ethical Committee (IEC PROTOCOL NO: SBBDC/2023/382) before commencing the study. Ten schools were randomly selected from each zone, and children meeting the inclusion and exclusion criteria were included after obtaining informed consent from their parents.

To minimize inter-examiner bias, a single examiner conducted the clinical examination under adequate natural light in a school setting. The children sat on stools in an upright position while the examiner, positioned slightly to the right, inspected the teeth in a wet state. Dental caries were assessed using the DMFT index.

Data on the children’s oral hygiene practices and their parents’ oral health literacy were collected through a questionnaire. Socio-economic status was determined using the Kuppuswamy scale. Additionally, water samples from each school were collected and sent to a laboratory to assess the fluoride levels in the drinking water of each zone.

The study on dental caries prevalence in preschool children (ages 4-6) in Hapur district found a high overall prevalence rate of 88.4%, indicating a significant burden of dental caries in the region. The study included 2,500 children from five zones of Hapur district, providing broad representation.

There were no statistically significant differences in caries prevalence based on gender (p = 0.001) or socioeconomic status (p = 0.961), suggesting these factors did not notably influence caries rates. However, significant differences were observed in relation to oral hygiene practices (p = 0.001) and oral health literacy (p = 0.001). Children with better oral hygiene and higher oral health literacy had lower caries rates, highlighting the importance of educating both parents and children about proper oral care. Poorer oral hygiene practices were linked to higher caries prevalence, underscoring the role of daily oral care in preventing dental decay.

The discussion highlights the global impact of Early Childhood Caries (ECC), affecting over 530 million children worldwide and leading to pain, difficulty eating, and long-term health issues. Despite preventive measures in developed countries, ECC remains prevalent in developing regions like India, with preschool prevalence estimated at 54%–57%. In Hapur district, Uttar Pradesh, the study found an ECC prevalence of 86.8% in children aged 4-6 years.

The study revealed that better oral hygiene and higher oral health literacy were linked to lower caries prevalence, emphasizing the need for improved education and hygiene practices. Gender differences in ECC prevalence were inconsistent, and the relationship between socioeconomic status (SES) and caries was mixed. Some areas showed higher prevalence in higher SES groups, while other studies suggest lower SES as a greater risk factor. Fluoride levels in drinking water were low (0.8 ppm), potentially contributing to the high prevalence, though no significant association was found.

The discussion stresses the need for better preventive care, oral hygiene education, and community-based interventions, along with integrating oral health programs into schools, promoting good dietary habits, and increasing fluoride levels in water to reduce ECC. The study calls for targeted strategies to address local risk factors and improve children’s oral health in Hapur and similar regions.

 
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