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CTRI Number  CTRI/2024/12/077688 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparison of Antimicrobial efficacy of four different pediatric toothpaste for organisms causing ECC.  
Scientific Title of Study   A Comparative Study on the Role of Smart Phone Application in Improving Oral Health with the Antimicrobial Efficacy of Paediatric Dentifrices along with Salivary alpha-amylase in Early Childhood Caries  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arunima Sarkar 
Designation  POST GRADUTE 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences Uttar Pradesh 
Address  DEPARTMENT NO -5, SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL SCIENCES AND RESEARCH.
DEPARTMENT NO -5, SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL SCIENCES AND RESEARCH.
Lucknow
UTTAR PRADESH
226001
India 
Phone  09001713480  
Fax    
Email  arunimasarkar08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Gunjan Yadav 
Designation  Professor and Head of the Department 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences Uttar Pradesh 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL SCIENCES AND RESEARCH.
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL SCIENCES AND RESEARCH.
Lucknow
UTTAR PRADESH
226001
India 
Phone  09454109142  
Fax    
Email  drgunjany@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arunima Sarkar 
Designation  POST GRADUTE 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences Uttar Pradesh 
Address  ROOM NO -05, SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL SCIENCES AND RESEARCH.
ROOM NO -05, SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL SCIENCES AND RESEARCH.
Lucknow
UTTAR PRADESH
226001
India 
Phone  09001713480  
Fax    
Email  arunimasarkar08@gmail.com  
 
Source of Monetary or Material Support  
SARDAR PATEL POSTGRADUATE INSTITUTE OF MEDICAL AND DENTAL SCIENCES, LUCKNOW 
 
Primary Sponsor  
Name  Arunima Sarkar 
Address  ROOM NO 05, Sardar Patel Post Graduate Institute of Dental and Medical Sciences.Chaudhary Vihar, Uthrathia, Raibareilly road, 226025 
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 ARUNIMA SARKAR  SARDAR PATEL POSTGRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES  Room no 05, Department of Pediatric and Preventive Dentistry, SPPGIDMS,Chaudhary Vihar, Utrathia, Raebareily Road Lucknow – 226025 – Uttar Pradesh
Lucknow
UTTAR PRADESH 
9001713480

arunimasarkar08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, SARDAR 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  KIDODENT(458 PPM), JL MORRISON (NON FLUORIDATED), PATANJALI (HERBAL) KIDS.  THE VARIOUS PEDIATRIC DENTRIFRICES WILL BE GIVEN FOR INTERVENTION FOR EARLY CHILDHOOD CARIES. BEFORE INTERVENTION SALIVA WOULD BE COLLECTED, THEN ON RANDOM ALLOCATION DENTRIFRICES WILL BE PROVIDED AND AFTER 15 DAYS THE COLLECTION OF SALIVA WILL BE DONE FOR CHECKING THE EFFICACY OF THE DENTIFRICES. 
Intervention  PEDIFLOR (1000 PPM)  THE VARIOUS PEDIATRIC DENTRIFRICES WILL BE GIVEN FOR INTERVENTION FOR EARLY CHILDHOOD CARIES. BEFORE INTERVENTION SALIVA WOULD BE COLLECTED, THEN ON RANDOM ALLOCATION DENTRIFRICES WILL BE PROVIDED AND AFTER 15 DAYS THE COLLECTION OF SALIVA WILL BE DONE FOR CHECKING THE EFFICACY OF THE DENTIFRICES. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.Children between 3-6 years of age.
2.Children having Early Childhood Caries.
3.Children with a DMFT score of 4 or more
4.Children with cooperative behaviour rating 3 & 4 in the Frankel behaviour rating scale.
5.Children who will be willing to show participation in this study.
6.Children whose parents will give informed consent.
 
 
ExclusionCriteria 
Details  1.Children with any underlying systemic condition.
2.Children who have received systemic antibiotics recently.
3.Children who are categorised as specially abled child.
4.Children with a recent history of professionally applied topical fluoride.
5.Children with any marked intraoral soft tissue pathology.
6.Children with definitely negative Frankl’s behaviour rating.
7.Children undergoing orthodontic procedures or those with an intraoral prosthesis.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The outcome expected out of this research is the comparison of the efficacy of High fluoridated (1000 ppm), commonly used paediatric dentifrices along with the traditionally followed Low Fluoridated (458 ppm), Non- Fluoridated and Herbal Formulations available in the market against the most common causative microorganism found in Early Childhood Caries
 
2 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   14/12/2024 
Date of Study Completion (India) 30/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
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)  

The human oral cavity is one of the most densely populated sites in the body. It contains a diversity of microbial populations that give rise to distinct bacterial communities, including dental caries and dental plaque.1 Dental caries stands as the most widespread infectious microbial ailment on a global scale.2 It is often caused by acidic demineralization of tooth enamel and dentin due to biofilm produced by microorganisms associated with plaque. Dental plaque forms when bacteria colonise the acquired enamel pellicle.1 1 gram of plaque contains 1011 bacteria. While dental plaque occurs naturally, it is also linked to two of the most common diseases in industrialized societies: caries and periodontal diseases.2

Early Childhood Caries (ECC) is recognized as the most severe and damaging manifestation of dental caries, impacting children under the age of 6. The leading organism of the microbiota of oral cavity is Streptococcus mutans (SM) and its elevated level in the saliva has been the primary factor causing Early Childhood Caries.3 By decomposing sugars present on the surface of the tooth, this facultative anaerobe generates an environment that is acidic, leading to the eventual demineralization of calcium on the surface of the tooth. Lactobacillus acidophilus is the second most common microorganism found in oral microflora. While not serving as the initiator of caries, it plays a crucial role in the progression of dental decay. The primary characteristic of the Lactobacillus genera is the production of acids from sugars that are fermentable, which contribute to the process of tooth decay.4

Also, Saliva plays an important role as a non-invasive local tool for diagnosis of systemic diseases, as it consists of glycoprotein, electrolytes, immunoglobulins and variety of enzymes. The omnipresent enzyme in saliva is salivary alpha-amylase, which hydrolyses  insoluble form of starch into the form which is soluble and helps in the digestion of carbohydrates. The enzyme’s notable characteristic is its strong affinity for binding to both tooth structure and streptococci present in oral cavity and therefore increased salivary alpha-amylase levels indicate the presence of dental caries in the oral cavity. 5

Mechanical oral hygiene aids are the most effective method for the prevention of dental caries and dental Plaque including toothbrushes and toothpaste.6 The dentifrices are available under various categories such as fluoridated and non-fluoridated, depending on the amount of fluoride content in the toothpaste. Fluoride possesses antimicrobial properties that hinder the growth of microorganisms, slowing down plaque development by reducing their ability to produce acids.7 Fluoridated toothpastes are further classified as Low fluoridated (<500 ppm) and High fluoridated(>500 ppm) but have various controversial aspects to it. High fluoridated toothpaste aids in preventing tooth decay by reinforcing the enamel and enhancing its resistance to acid attacks from bacteria as there are reports stating concerns about the acute fluoride toxicity caused by ingestion of fluoridated toothpastes.8 In the realm of dentistry, traditionally low or non-fluoridated toothpastes were popularised because of the propensity for swallowing and the risk of fluorosis.8 With the growing popularity of Herbal toothpaste nowadays, we are compelled to research and determine the efficacy of these toothpaste as Herbal extracts contain phytochemicals that can offer pathways preventing caries of dental origin.

Researchers have undertaken various studies to compare the efficacy of different dentifrices. There have been studies comparing fluoridated dentifrices with other Non -fluoridated as well as Herbal dentifrices. As of today, there is no documented research conducted in India for the use of highly fluoridated dentifrices in children with Early childhood caries.

 
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