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CTRI Number  CTRI/2024/02/062753 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 15/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Evaluating the effectiveness of herbal toothpaste in the reduction of tooth debris and gum diseases in adults 
Scientific Title of Study   Evaluation of efficacy and acceptability of herbal toothpaste in the reduction of plaque and gingival inflammation in healthy adult population – A Multicentric pilot 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 Ashok Dhoble  
Designation  BDS, MDS, Orthodontics and Dentofacial Orthopedics  
Affiliation  Indian Dental Association  
Address  Room B Community clinics research department Dr APJ Abdul Kalam Education Research and Incubation center 3rd Floor Unit no 3A and B Zone 1 DGP House 88C Old Prabhadevi Road Prabhadevi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400025
India 
Phone  9820094499  
Fax    
Email  ashokdhoble@ida.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Dhoble  
Designation  BDS, MDS, Orthodontics and Dentofacial Orthopedics  
Affiliation  Indian Dental Association  
Address  Room B Community clinics research department Dr APJ Abdul Kalam Education Research and Incubation center 3rd Floor Unit no 3A and B Zone 1 DGP House 88C Old Prabhadevi Road Prabhadevi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400025
India 
Phone  9820094499  
Fax    
Email  ashokdhoble@ida.org.in  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Dhoble  
Designation  BDS, MDS, Orthodontics and Dentofacial Orthopedics  
Affiliation  Indian Dental Association  
Address  Room B Community clinics research department Dr APJ Abdul Kalam Education Research and Incubation center 3rd Floor Unit no 3A and B Zone 1 DGP House 88C Old Prabhadevi Road Prabhadevi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400025
India 
Phone  9820094499  
Fax    
Email  ashokdhoble@ida.org.in  
 
Source of Monetary or Material Support  
Dabur Research & Development Centre 
 
Primary Sponsor  
Name  Dabur Research & Development Centre 
Address  22 Site IV Sahibabad Industrial Area Ghaziabad 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Minal Kumthekar   Dr APJ Abdul Kalam Education Reserach and Incubation Center   Room B Community clinics research department Dr APJ Abdul Kalam Education Research and Incubation center 3rd Floor Unit no 3A and B Zone 1 DGP House 88C Old Prabhadevi Road Prabhadevi Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 8390888047

minal.dentist@gmail.com 
Dr Sushant Mohanty  Institute of Dental Sciences  Room no 5 Department of pediatric and preventive dentistry Institute of Dental Sciences, K8 Kalinga Nagar, Sum Hospital Road, Bhubaneswar 751003, Dist Khurda, Odisha
Khordha
ORISSA 		 9437037512

dr.susantmohanty@gmail.com 
DR MANISH KHATRI   Institute of Dental Studies and Technologies   Room 7 Department of periodontology IDST, NH 58, DELHI MEERUT ROAD, KADRABAD, MODINAGAR
Ghaziabad
UTTAR PRADESH 		 9810720335

drmanishkhatri@yahoo.com 
Dr Vaibhav Thakkar  MGM Dental College & Hospital,  Room 6 Department of Public health dentistry Junction of NH4 & Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai 410209
Raigarh
MAHARASHTRA 		 9322262227

drvaibhav.h32@gmail.com 
Dr Yamuna Marella   SIBAR institute of dental sciences  Room No A 2nd floor Department of periodontology SIBAR Institute of dental sciences, Takkellapadu, Guntur-522509, Andhra Pradesh
Guntur
ANDHRA PRADESH 		 8142747691

yamuna.marella99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
DR APJ ABDUL KALAM EDUCATION RESEARCH CENTSEARCH CENTRE AND SUPERSPECIALITY DENTAL CLINIC   Approved 
Institute of Dental Studies & Technologies Ethics Committee  Approved 
Institutional Ethics committee - Institute of Dental Sciences   Approved 
Institutional Ethics committee, MGM Dental College & Hospital, Kamothe, Navi Mumbai  Submittted/Under Review 
Institutional ethics committee, SIBAR institute of dental sciences.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Diseases of oral cavity  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dabur red toothpaste   Tooth paste to be used for brushing twice daily for 3 months  
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects with plaque scores above 1
Subjects with gingival scores between 1 and 2
Subjects showing signs of mild marginal gingival inflammation

 
 
ExclusionCriteria 
Details  Subjects with gingival scores more than 2
Subjects with a known history or present condition of hypersensitivity to any toothpaste,
The use of antibiotics, antimicrobial, analgesic medications, mouthwash, or desensitizing toothpaste during the previous one month,
Any history of periodontal therapy by surgical interventions,
History of dentine hypersensitivity treatment
History of smoking or smokless tobacco products
Subjects who are pregnant, lactating or nursing
Subjects with severe calculus or tartar
Subjects with uncontrolled medical illness like HIV, hepatitis etc
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the Plaque and Gingival scores

Changes in the clinical signs of marginal gingival inflammation

 		 Plaque and gingival score to be assessed at 1
monthi.e at 1st followup 2 months i.e at2nd
followup and 3 months i.e at 3rd followup
 
 
Secondary Outcome  
Outcome  TimePoints 
Understanding of the products acceptability through survey data points   acceptability and tolerability to be assessed after
1 month 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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 3/ Phase 4 
Date of First Enrollment (India)   26/02/2024 
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="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 an open-label multi-centric clinical trial conducted across 5 centers across India. Total sample size of the study is 300. The study aims to assess the efficacy and efficiency of the toothpaste in its antiplaque and anti-gingivitis properties and to evaluate the acceptability, tolerability, and safety of the toothpaste among the adult population.  
The primary outcome of the study is changes in the plaque and gingival scores and changes in the clinical signs of gingiva inflammation. The secondary outcome is the assessment of its acceptability and tolerability through survey data points. 
 
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