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CTRI Number  CTRI/2025/05/087652 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 06/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Impact of Healthy Eating and Soft Drinks in Tooth Decay 
Scientific Title of Study   Exploring The Impact Of Healthy Eating and Sugar-Sweetened Beverages to Oral Microbial Balance in Early Childhood Caries: 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 Rishita Chaudhary 
Designation  Postgraduate Student 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department of Pediatric and Preventive Dentistry, Floor no.3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences.

Lucknow
UTTAR PRADESH
226025
India 
Phone  9305253244  
Fax    
Email  rishitachaudhary@icloud.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonali Saha 
Designation  Professor and Director 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department of Pediatric and Preventive Dentistry, Floor no.3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences.

Lucknow
UTTAR PRADESH
226025
India 
Phone  9889234995  
Fax    
Email  drsonalisaha24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rishita Chaudhary 
Designation  Postgraduate Student 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department of Pediatric and Preventive Dentistry, Floor no.3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences.

Lucknow
UTTAR PRADESH
226025
India 
Phone  9305253244  
Fax    
Email  rishitachaudhary@icloud.com  
 
Source of Monetary or Material Support  
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India, Pincode-226025 
 
Primary Sponsor  
Name  Dr Rishita Chaudhary 
Address  Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India, PIN: 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 Rishita Chaudhary  Sardar Patel Post Graduate Institute of Dental and Medical Sciences   Department of Pediatric and Preventive Dentistry, Floor no. 3
Lucknow
UTTAR PRADESH 
9305253244

rishitachaudhary@icloud.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals who have / had no carious lesions 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Children between 2-6years of age of both sexes.
2. Children having Early Childhood Caries(ECC).
3. Children whose parents would give consent to participate in the study.
4. Co-operative children ranking 3 & 4 in the Frankl behaviour rating scale. 
 
ExclusionCriteria 
Details  1. Non Co-operative children
2. Children with any special healthcare needs, congenital illness, mental illness, oral infection and lesion, and any other systemic conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the association of Healthy Eating and Sugar-Sweetened Beverages with Oral Bacterial Count in caries-free children, children with ECC and S-ECC amongst preschool children of Lucknow city  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Association of parent’s socio-economic status (SES) and caries severity among preschool children.

2. Association of Streptococcus mutans count and intake of Sugar-sweetened beverages in caries-free children and children with ECC and S-ECC.

3. Association of Streptococcus sanguinis count and intake of Sugar-sweetened beverages in caries-free children and children with ECC and S-ECC.

4. Association of Streptococcus mutans count and Healthy Eating Index in caries-free children and children with ECC and S-ECC.

5. Association of Streptococcus sanguinis count and Healthy Eating Index in caries-free children and children with ECC and S-ECC.  
2 weeks 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   31/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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)  Open to Recruitment 
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  

Early childhood caries (ECC) is reported as the most prevalent chronic condition in children, with over 1.8 billion new cases identified annually worldwide. According to American Academy of Pediatric Dentistry (AAPD), ECC is the presence of 1 or more decayed (noncavitated or cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth in a child 71 months of age or younger. In children younger than 3 years of age, any sign of smooth-surface caries is indicative of severe early childhood caries (S-ECC). From ages 3 through 5, 1 or more cavitated, missing (due to caries), or filled smooth surfaces in primary maxillary anterior teeth or a decayed, missing, or filled score of more than or equal to 4 (age 3), more than or equal to 5 (age 4), or more than or equal to 6 (age 5) surfaces constitutes S-ECC. 

Complex, multispecies communities of microflora live in the oral cavity in a homeostatic environment. These native microflorae are important in protecting the host from invasions by different foreign infections, but dental caries may develop if this homeostasis is upset. Dental caries is thought to be caused by a combination of biological and environmental variables, including dental plaque, saliva, fluoride consumption, oral hygiene, and food. Streptococcus mutans and Lactobacillus casei are two of the many bacteria that contribute to the development of dental caries However, it was shown that the cariogenic bacteria S. mutans and S. sobrinus, which belong to the Mutans Streptococci family, are mostly linked to tooth caries. Nevertheless, it has also been documented that other oral streptococcus bacteria, such as S. sanguinis, S. oralis, S. gordonii, and S. salivarius, influence cariogenicity by modifying the biofilm community and interacting with MS during the caries process.

Streptococcus mutans is the oral microbial flora that is mostly implicated with ECC. It is a facultative anaerobic, Gram-positive bacterium that typically survives as a normal part of the oral bacterial population. However, when fermentable carbohydrates are present, these acid-producing organisms destroy teeth by dissolving their structure. A common tooth colonizer, Streptococcus sanguinis is a Gram-positive facultative anaerobic bacterium whose presence is linked to the presence of healthy biofilms and the lack of dental caries. Therefore, knowing how oral streptococci contribute to dental caries may become more crucial for disease prevention.   

In order to determine the function of streptococcal species in S-ECC, prior studies examined tooth plaque. It was asserted, meanwhile, that dental plaque did not accurately represent the incidence of oral bacteria and MS. Colonization of MS over the entire dentition is best observed in saliva, hence it was recommended as a substitute for plaque. It was discovered that MS remained in saliva due to its surface antigen proteins.

This illness is associated with a number of risk factors: Due to certain characteristics of the bacterium and predisposing factors associated with the host’s oral cavity, Streptococcus mutans can easily and quickly colonize a child’s oral cavity. For example, structural characteristics of the enamel and dentin in the primary dentition can predispose to decay; poor oral hygiene, which results in the deposit of plaque, can affect Streptococcus mutans colonization; poor dietary habits and low socioeconomic status can contribute to the onset of decay. 

A higher risk of dental caries has been linked to the consumption of sugar and sugar-sweetened beverages (SSB) in the form of sodas, energy drinks, fruit-flavoured drinks, and, to a lesser extent, 100% juice. Two-thirds of children between the ages of two and nineteen consumed at least one sugar-sweetened beverage (SSB) on any given day, according to an analysis of the National Health and Nutrition Examination Survey (NHANES) 2011 to 2014. Children who consumed SSB also experienced significantly higher levels of untreated dental caries than children who consumed other beverage types.


 
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