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CTRI Number  CTRI/2025/03/083579 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluating the Impact of Two Toothpaste Formulations on Plaque and Gingival Health in Children: A Randomized Controlled Trial 
Scientific Title of Study   Comparison of the effectiveness of two different toothpastes formulation in the reduction of plaque and gingival inflammation among 6-12 years old children -A randomized controlled trial 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanca Panigrahi 
Designation  Post Graduate Trainee 
Affiliation  Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar 
Address  Room no 9, Department of Public Health Dentistry, Institute of dental sciences, Siksha O Anusandhan University , Bhubanswar

Khordha
ORISSA
751003
India 
Phone  6370097824  
Fax    
Email  priyancapanigrahi07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanca Panigrahi 
Designation  Post Graduate Trainee 
Affiliation  Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar 
Address  Institute of dental sciences, Siksha O Anusandhan University , bhubanswar

Khordha
ORISSA
751003
India 
Phone  6370097824  
Fax    
Email  priyancapanigrahi07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanca Panigrahi 
Designation  Post Graduate Trainee 
Affiliation  Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar 
Address  Roomno 9, Department of Public Health Dentistry Institute of dental sciences, Siksha O Anusandhan University , bhubanswar

Khordha
ORISSA
751003
India 
Phone  6370097824  
Fax    
Email  priyancapanigrahi07@gmail.com  
 
Source of Monetary or Material Support  
Roomno 9, Department of Public Health Dentistry,Institute of dental sciences, kalinga nagar,pun-751003, Bhubaneswar, odisha , India 
 
Primary Sponsor  
Name  self 
Address  Room no 9, Institute of dental sciences, Siksha O Anusandhan University , bhubanswar,Odisha, 751003 
Type of Sponsor  Research institution and hospital 
 
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 Priyanca Panigrahi  Institute of Dental sciences  Roomno 9, Department of Public Health Dentistry, Institute of Dental Sciences, Siksha O Anusandhan Deemed to be university, Kalinga nagar,Bhubaneswar,India,751003
Khordha
ORISSA 		 7683879877

panigrahipriyanca@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-INSTITUTE OD DENTAL SCIENCES, Siksha O Anusandhan ( deemed to be university) Accredited by NAAC of UGC   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children without any systemic diseases. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amala Earth kids toothpaste tablets .  Menthol (Mentha Arvensis), Meswak Extract (Salvadora Persica), Orange Essence, Orange Extract (Citrus Senesis), Carotene, Maize Starch, Mannitol, Xylitol, Sodium Starch Glycolate, Clove Powder (Syzygium Aromaticum) Calcium Carbonate, Natural salt (Sodium Chloride), Coconut derivative , Colloidal Silicon Dioxide, Magnesium Stearate Sodium Monoflurophosphate (Contains 500 ppm of max. of available fluoride when packed)((which shall be used twice daily for 21 days)) 
Comparator Agent  Cherrio toothpaste   Cheerio Fluoride Medicated Oral Gel is a medicated oral gel formulated to promote good dental hygiene in children. The gel contains fluoride, which is an essential mineral that has been shown to help prevent tooth decay and maintain healthy teeth. Cheerio toothpaste has a palatable flavour that is widely accepted by children. It is used for dental hygiene and is claimed to remove plaque and protect tooth enamel, remineralizing the areas of the tooth that have been affected by bacteria. The gel base is reportedly flavoured and coloured with Ponceau 4R and Titanium Dioxide IP, and the fluoride content is said to be 458 parts per million (PPM).((which shall be used twice daily for 21 days)) 
Intervention  little joy toothpaste  It consists of triphala extract , pomegranate extract , neem oil and aloevera extract. which helps toimprove gumhealth andreduces germs and plaque . its a fluoride free toothpaste (which shall be used twice daily for 21 days) 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Healthy participants without any systemic condition.
participants without any oral prophylaxis procedure from 6 months.
 
 
ExclusionCriteria 
Details  medically compromised children
Periodontally compromised children 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
improvement in Plaque , gingival bleeding and ph  improvement in Plaque , gingival bleeding and ph in baseline , 4th week, 8thweek 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in salivary ph   baseline , 7thday , 21st day. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/04/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   The study is a randomised , double blind, parallel group, multicentre trial, comparing the efficacy of two toothpastes formulations with controlled group in plaque  control and gingival bleeding in children from aged 6years to 12 years. The salivary ph of this children will also be assessed. The primary outcome measures the antiplaque efficacy , reduction in gingival bleeding and salivary ph. The evaluation will be assessed in baseline, 7thday, 21st days. 
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