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CTRI Number  CTRI/2024/07/070865 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A trial to study the effectiveness of chewable toothpaste tablets in plaque removal 
Scientific Title of Study   Evaluation of plaque removal efficacy in chewable toothpaste tablets: A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
harshit707  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshit Srivastava 
Designation  Post Graduate Student 
Affiliation  National Institute Of Medical Sciences Dental College and Hospital 
Address  Department of Public Health Dentistry, 3rd floor, clinic number 8

Jaipur
RAJASTHAN
303121
India 
Phone  7007637778  
Fax    
Email  hluxurious@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Naganandini S. 
Designation  Professor  
Affiliation  NIMS Dental College and Hospital 
Address  NIMS Dental College

Jaipur
RAJASTHAN
303121
India 
Phone  9448718754  
Fax    
Email  naganandini36@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harshit Srivastava 
Designation  Post Graduate Student 
Affiliation  National Institute Of Medical SciencesDental College and Hospital 
Address  Department of Public Health Dentistry, 3rd floor, clinic number 8

Jaipur
RAJASTHAN
303121
India 
Phone  7007637778  
Fax    
Email  hluxurious@gmail.com  
 
Source of Monetary or Material Support  
NIMS Dental College And Hospital NIMS UNIVERSITY RAJASTHAN Jaipur-Delhi Highway (NH-11C), Jaipur – 303121, Rajasthan 
 
Primary Sponsor  
Name  National Institute of Medical Sciences  
Address  Dr BS Tomar city, NH11-c, Highway, Jaipur-Delhi, Chandwaji, rajasthan 302131 
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 Harshit Srivastava  National Institute Of Medical Sciences Dental College  Department of Public Health Dentistry, 3rd floor, clinic number 8
Jaipur
RAJASTHAN 		 7007637778

hluxurious@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Nims University  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  Apollo Noni Chewable toothpaste tablet  1 tablet given orally, chewed and brushed twice daily for 1 week  
Comparator Agent  Teeth-a-bit chewable toothpaste tablet  1 tablet given orally, chewed and brushed twice daily for 1 week  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Subjects who are systemically healthy will be included in the study.
2.Subjects who are willing to use the tablets and has given consent to participate.
3.Subjects who agreed to discontinue oral hygiene measures during the intervention period.
 
 
ExclusionCriteria 
Details  1.Subjects who used antibiotics within last 15 days will be excluded.
2.Those with extensive untreated dental caries, diseases of hard and soft palate, subjects wearing orthodontic appliances or presenting with abnormal salivary flow.
3.Those with multiple tooth extraction will be excluded.
4.Subjects with established periodontitis will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess the plaque removal efficacy of apollo noni chewable toothpaste tablets using Turesky, Gilmore and Glickman Plaque Index.
2.To assess the plaque removal efficacy of teeth-a-bit chewable toothpaste tablets using Turesky, Gilmore and Glickman Plaque Index.
3.To compare the plaque scores before and after use of chewable toothpaste tablets.
 		 1st Intervention
At Baseline
After 1 week follow up
2nd Intervention
After washout period (1 week)
After 1 week follow up
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To check the acceptance of chewable toothpaste tablets.
2.To check for any adverse effects of chewable toothpaste tablets.
 		 Done using a questionnaire at the end of both the intervention after 4 weeks 
 
Target Sample Size   Total Sample Size="196"
Sample Size from India="196" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   25/07/2024 
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="1"
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   This randomized controlled trial aims to evaluate the plaque removal efficacy of chewable toothpaste tablets. The study will focus on two products: Apollo Noni and Teeth-a-Bit chewable toothpaste tablets. The primary objectives are to assess the effectiveness of each product in removing plaque using the Turesky, Gilmore, and Glickman Plaque Index, compare plaque scores before and after their use, and evaluate user acceptance and potential adverse effects. The central research question is whether there is a difference in plaque removal efficacy between the two products. The null hypothesis states that there will be no significant difference in efficacy between Apollo Noni and Teeth-a-Bit, while the alternative hypothesis suggests a significant difference will be observed. Participants will be assessed and selected for the study, following which they will be briefed about the study’s purpose and procedures. To establish a baseline, participants will be asked to abstain from their usual oral hygiene practices for 24 hours, and their plaque scores will be recorded. Following the baseline assessment, participants will enter a preparatory phase lasting one week. During this period, they receive training on using chewable toothpaste tablets and proper brushing techniques. After this preparatory phase, participants will begin using the first type of chewable toothpaste tablet for one week. At the end of this week, they again refrain from oral hygiene for 24 hours, and their plaque scores will be recorded to assess the impact of the first tablet. Subsequently, participants undergo a wash-out period of one week. At the end of this period, their plaque scores are recorded again after refraining from oral hygiene for 24 hours. In the final phase, participants use the second type of chewable toothpaste tablet for another week. Similar to the previous phase, they then refrain from oral hygiene for 24 hours, and their plaque scores are recorded. The data collected at these multiple stages include plaque scores measured after the initial baseline, after the use of the first toothpaste tablet, post-wash-out, and after the use of the second toothpaste tablet. By analyzing these plaque scores, the study aims to determine and compare the effectiveness of the two different chewable toothpaste tablets in reducing dental plaque. 
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