| 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
|
|
|
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
|
|
|
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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