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CTRI Number  CTRI/2026/04/108724 [Registered on: 20/04/2026] Trial Registered Prospectively
Last Modified On: 16/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of three toothpastes in reducing plaque and gum inflammation in patients with gingivitis 
Scientific Title of Study   Comparative evaluation of the antiplaque efficacy of two herbal toothpastes and a triclosan containing toothpaste A randomized clinical crossover study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NU24DPER02  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pujita 
Designation  Postgraduate student 
Affiliation  A B Shetty Memorial Institute of Dental Sciences 
Address  Department of Periodontics, A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangaluru
Karnataka
Dakshina Kannada
KARNATAKA
575018
India 
Phone  07014798477  
Fax    
Email  pujita98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Biju Thomas 
Designation  Proffessor 
Affiliation  A B Shetty Memorial Institute of Dental Sciences 
Address  Department of Periodontics, A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangaluru
A B Shetty Memorial Institute of Dental Sciences
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448953418  
Fax    
Email  drbiju@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Biju Thomas 
Designation  Proffessor 
Affiliation  A B Shetty Memorial Institute of Dental Sciences 
Address  Department of Periodontics, A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangaluru
A B Shetty Memorial Institute of Dental Sciences
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448953418  
Fax    
Email  drbiju@nitte.edu.in  
 
Source of Monetary or Material Support  
A B Shetty Memorial Institute of Dental Sciences, Nitte University, Deralakatte, Mangalore, Karnataka, India 575018 
 
Primary Sponsor  
Name  A B Shetty Memorial Institute of Dental Sciences 
Address  AB Shetty Memorial institute of dental sciences, mangalore 
Type of Sponsor  Research institution 
 
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 Biju Thomas  A B Shetty Memorial Institute of Dental Sciences  Department of Periodontics, Nitte University, Deralakatte, Mangalore, Karnataka, India 575018
Dakshina Kannada
KARNATAKA 		 09448953418

drbiju@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, A B Shetty Memorial Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K050||Acute gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Herbal Toothpaste 1   Herbal dentifrice used twice daily for three days 
Intervention  Herbal Toothpaste 2  Herbal dentifrice used twice daily for three days 
Comparator Agent  Triclosan Toothpaste (Colgate Total)  Triclosan containing dentifrice used twice daily for three days 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  Patients aged 18 to 30 years with mild to moderate gingivitis. Patients willing to participate and provide informed consent. 
 
ExclusionCriteria 
Details  Patients with periodontitis. Patients with systemic diseases affecting the periodontium. Pregnant or lactating women. Patients undergoing orthodontic treatment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in plaque index and gingival index scores after use of different toothpastes  Baseline and after three days of use for each toothpaste phase 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of antiplaque efficacy between herbal toothpastes & triclosan toothpaste toothpaste  Baseline & after three days of use for each toothpaste phase 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   15/05/2026 
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 Yet Recruiting 
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 study aims to evaluate and compare the antiplaque efficacy of two herbal toothpastes and a triclosan containing toothpaste in patients with mild to moderate gingivitis. The study is designed as a randomized clinical crossover study. Participants aged 18 to 30 years will be included and will use each toothpaste for a period of three days with a washout period between interventions. Plaque index and gingival index scores will be recorded at baseline and after each intervention phase. The results will help in assessing the effectiveness of herbal dentifrices compared to conventional triclosan containing toothpaste in controlling plaque and gingival inflammation. 
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