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CTRI Number  CTRI/2024/12/078271 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 25/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding the Rise of Tooth Decay in Young Children and Related Parent Factors in Lucknow: A Study of Kids Aged 3-6 years. 
Scientific Title of Study   Prevalence of Early Childhood Caries (ECC) and Associated Parental Risk Indicators in Preschool Children aged 36-72 months of Lucknow City: A Cross-Sectional 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  Dr Mitusmita Kalita 
Designation  Postgraduate student 
Affiliation  Sardar Patel Postgraduate Institute of Dental and Medical Sciences 
Address  Department of Pediatric and Preventive Dentistry, floor no. - 3
Department of Pediatric and Preventive Dentistry, floor no. - 3
Lucknow
UTTAR PRADESH
226025
India 
Phone  7002980030  
Fax    
Email  mitusmitakalita95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonali Saha 
Designation  Professor and Director 
Affiliation  Sardar Patel Postgraduate Institute of Dental and Medical Sciences 
Address  Department of Pediatric and Preventive Dentistry, floor no. - 3
Department of Pediatric and Preventive Dentistry, floor no. - 3
Lucknow
UTTAR PRADESH
226025
India 
Phone  9889234995  
Fax    
Email  drsonalisaha24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mitusmita Kalita 
Designation  Postgraduate student 
Affiliation  Sardar Patel Postgraduate Institute of Dental and Medical Sciences 
Address  Department of Pediatric and Preventive Dentistry, floor no. - 3
Department of Pediatric and Preventive Dentistry, floor no. - 3
Lucknow
UTTAR PRADESH
226025
India 
Phone  7002980030  
Fax    
Email  mitusmitakalita95@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow, uttar pradesh,India, Pincode - 226025 
 
Primary Sponsor  
Name  Dr Mitusmita Kalita 
Address  Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India, Pincode-226025 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Mitusmita Kalita  Sardar Patel Postgraduate Institute of Dental and Medical Sciences  SPPGIDMS, Department of Pediatric and Preventive Dentistry, Floor no.-3
Lucknow
UTTAR PRADESH 
7002980030

mitusmitakalita95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Sarder Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Early Childhood Caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  36.00 Month(s)
Age To  72.00 Month(s)
Gender  Both 
Details  a) Children between 36-72 months of age.
b) Children having Early childhood caries (ECC).
c) Preschool children whose parents had given consent for participation in the study for their child.
d) Children with cooperative behaviour ranking 3 & 4 in the Frankel behaviour rating scale.
e) Children whose parents are residing in Lucknow for three generations.
 
 
ExclusionCriteria 
Details  a) Children who are non-cooperative during the procedure.
b) More than one child per family.
c) Children with any congenital illness, mental illness, developmental anomalies of teeth, oral infection and lesion, acute tonsillitis and any other systemic diseases.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Information gathered from this study may help in serving as a base for the planning and assessment together with the execution of oral health promotional programs at a community level. Since the potential to increase knowledge of ECC is high because of various initiatives taking place in the society, emphasizing prolonged behavioral changes among parents would be our ultimate goal.   at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the parental risk factors of ECC, b) To find out the relationship between the prevalence & parental risk indicators.
c) To find out the parent’s socio-economic status (SES) associated with the prevalence of ECC.
d) To find out the parent’s oral health knowledge associated with the prevalence of ECC.
e) To find out the parent’s oral health behaviour & dietary habits associated with the prevalence of ECC.
f) To find out the parental stress associated with the prevalence of ECC.
g) To find out the dental anxiety associated with the prevalence of ECC.

h) To find out the sense of coherence (SOC) associated with the prevalence of ECC.
 
at baseline 
 
Target Sample Size   Total Sample Size="768"
Sample Size from India="768" 
Final Enrollment numbers achieved (Total)= "770"
Final Enrollment numbers achieved (India)="770" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/12/2024 
Date of Study Completion (India) 31/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
ECC or early childhood caries is contemplated as a major prevalent, chronic condition during childhood. It happens to be a crucial public health issue that has a substantial influence on the lives of individuals and families including communities. Its varied consequences may range from pain and compromised chewing ability affecting the overall growth and development of the child ultimately resulting in a decreased quality of life.1 
In various populations of developed countries, the diverse risk factors and underlying causes are being investigated. On the contrary for emerging countries where the incidence of ECC seems to be rising, similar literature is very scanty.2,3 A worldwide variation in ECC prevalence has been observed. According to many research studies in countries that are developed, the incidence of Early Childhood Caries ranges between 1 to 12% as compared to a high prevalence of 70% in developing countries.4,5 The overall prevalence of ECC as reported by research work done in different regions of India ranges between 27 and 42%.6,7,8 
ECC happens to be the consequence of a heterogeneous culmination of various factors such as genetic, biological and biochemical together with an additional difficulty of different oral health social determinants.9 Even though biological determinants have been studied in detail, further investigation needs to be done to evaluate the social determinants influencing oral health together with their impact on ECC occurrence and progression.10
Despite the serious problems arising due to ECC together with its high prevalence recorded in developing countries like ours, measures that could contribute to make this condition wholly preventable have not been executed and put into action. This happens to be the most tragic fact regarding this disease.11
Hence, it becomes imperative to have a thorough knowledge on the prevalence of ECC together with its associated risk factors to consequently develop targeted interventions for its prevention ultimately decreasing the total number of children requiring treatment during an emergency.
To the best of our knowledge, since there is no previous literature supporting the association of parental risk indicators and child characteristics with the severity of caries done in the Lucknow population, hence this present study aims to ascertain the prevalence and severity of ECC and its relationship with parental risk indicators in preschool children aged 36 – 72 months old in Lucknow, Uttar Pradesh.

 
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