| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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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