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CTRI Number  CTRI/2025/07/090938 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison Between Chewable and Regular Toothpaste to Find Out Which Works Better in Young Adults 
Scientific Title of Study   Comparative Analysis of Oral Hygiene Efficacy of Chewable Toothpaste Tablet Against Traditional Toothpaste in Undergraduate Students Aged 18-21 Years - A Randomized Controlled Trial 
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 Swayam Sourav Tripathy 
Designation  MDS Student 
Affiliation  Teerthanker Mahaveer Dental College and Research Centre 
Address  Department of Public Health Dentistry, Room No 809, Teerthanker Mahaveer Dental College and Research Centre, Teerthanker Mahaveer University, Moradabad, Uttar Pradesh

Moradabad
UTTAR PRADESH
244001
India 
Phone  8249363780  
Fax    
Email  swayamsouravtripathy95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikas Singh 
Designation  Professor and Guide 
Affiliation  Teerthanker Mahaveer Dental College and Research Centre 
Address  Department of Public Health Dentistry, Room No 809, Teerthanker Mahaveer Dental College and Research Centre, Teerthanker Mahaveer University, Moradabad, Uttar Pradesh

Moradabad
UTTAR PRADESH
244001
India 
Phone  9410095005  
Fax    
Email  drvikas.dental@tmu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Vikas Singh 
Designation  Professor and Guide 
Affiliation  Teerthanker Mahaveer Dental College and Research Centre 
Address  Department of Public Health Dentistry, Room No 809, Teerthanker Mahaveer Dental College and Research Centre, Teerthanker Mahaveer University, Moradabad, Uttar Pradesh

Moradabad
UTTAR PRADESH
244001
India 
Phone  9410095005  
Fax    
Email  drvikas.dental@tmu.ac.in  
 
Source of Monetary or Material Support  
Teerthanker Mahaveer Dental College and Research Centre 
 
Primary Sponsor  
Name  Dr Swayam Sourav Tripathy 
Address  Room no 809, Department of Public Health Dentistry, Teerthanker Mahaveer Dental College and Research Centre, Teerthanker Mahaveer University, Delhi Road, Moradabad, Uttar Pradesh - 244001, India 
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 Swayam Sourav Tripathy  Teerthanker Mahaveer Dental College and Research Centre  Department of Public Health Dentistry, Room No 809, Teerthanker Mahaveer University, Delhi Road, Moradabad – 244001, Uttar Pradesh, India
Moradabad
UTTAR PRADESH 		 8249363780

swayamsouravtripathy95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Teerthanker Mahaveer Dental College and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chewable Toothpaste Tablet  A total of 86 participants will use one Chewable Toothpaste Tablet per brushing session, twice daily for 30 days, with each session lasting 2 to 3 minutes, as per the provided instructions. 
Comparator Agent  Traditional Toothpaste  A total of 86 participants will use a pea-sized amount of Traditional Toothpaste twice daily for 30 days, with each session lasting 2 to 3 minutes, according to the provided instructions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  Dental students of both genders between the age group of 18 and 21 years, who are studying in Teeerthanker Mahaveer Dental College and Research Centre, present on the evaluation day and are consenting and willing to participate in the study. 
 
ExclusionCriteria 
Details  Those who do not study in the Teerthanker Mahaveer Dental College and Research Centre, and those refuse to participate in the study, or are outside the desired age group of 18 to 21 years. Students with underlying Systemic Diseases or severe underlying Dental Diseases. The Students who are undergoing Dental Treatment, including any ongoing orthodontic treatment will be excluded from
the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Oral Hygiene status measured by the help of Oral Hygiene Index - Simplified  Outcomes will be assessed at Day 0 and at Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
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   Phase 4 
Date of First Enrollment (India)   29/07/2025 
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="1"
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   This is a single-centre, randomized, parallel, single-blind, controlled trial evaluating the oral hygiene efficacy of a traditional toothpaste in comparison to a chewable toothpaste. The study will assess the reduction in plaque and calculus as measured by the Oral Hygiene Index - Simplified (OHI-S). The trial will be conducted over a 1-month period among 172 undergraduate dental students aged 18 to 21 years from Teerthanker Mahaveer Dental College and Research Centre. The primary outcome is the change in oral hygiene status, as determined by the OHI-S. 
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