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CTRI Number  CTRI/2025/06/089292 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Oral care product]  
Study Design  Single Arm Study 
Public Title of Study   Clinical Study on efficacy of Activated Charcoal Pro plus toothpaste. 
Scientific Title of Study   Evaluation of the efficacy of Activated Charcoal Pro plus toothpaste in improving teeth whitening and overall oral hygiene improvement. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/25-26/004 Version: 1.00; dated, 15 April 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhagyashri Gunjkar 
Designation  Principal Investigator 
Affiliation  Gunjkar Multispeciality Hospital 
Address  Plot No 315, Sector No 18, Spine Road, Chikhali

Pune
MAHARASHTRA
411062
India 
Phone  9823776981  
Fax  -  
Email  drbhagyashri.gunjkarresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rhythm Batra 
Designation  Manager- Product Awareness & Research 
Affiliation  Chipper Consumer Pvt. Ltd 
Address  Plot No. 250, Lynx House, 3rd Floor, Udyog Vihar, Phase IV, Sector 18,NCR.

Gurgaon
HARYANA
122015
India 
Phone  9711887082  
Fax  -  
Email  rhythm@perforacare.com  
 
Details of Contact Person
Public Query  
Name  Mr Ashish Goel 
Designation  Lead- NPD & SCM 
Affiliation  Chipper Consumer Pvt. Ltd 
Address  Plot No. 250, Lynx House, 3rd Floor, Udyog Vihar, Phase IV, Sector 18,NCR.

Gurgaon
HARYANA
122015
India 
Phone  9953777707  
Fax  -  
Email  ashish@perforacare.com  
 
Source of Monetary or Material Support  
Chipper Consumer Pvt. Ltd. Plot No. 250, Lynx House, 3rd Floor, Udyog Vihar, Phase IV, Sector 18,Gurugram, Haryana-122015, NCR, India. 
 
Primary Sponsor
Modification(s)  
Name  Chipper Consumer Pvt Ltd Perfora  
Address  Plot No. 250, Lynx House, 3rd Floor, Udyog Vihar, Phase IV, Sector 18,Gurugram, Haryana-122015, NCR, India. 
Type of Sponsor  Other [Cosmeceutical Industry] 
 
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 Bhagyashri Gunjkar  Gunjkar Multispeciality Hospital  Plot No 315, Sector No 18, Spine Road, Chikhali, Pune
Pune
MAHARASHTRA 		 9823776981
-
drbhagyashri.gunjkarresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sangvi Multispecialty Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Oral Health and Teeth Whitening 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Activated Charcoal Pro+ toothpaste  All participants will be advised to use a pea-sized amount of Activated Charcoal Pro+ toothpaste, gently brushing their teeth twice a day, in the morning and at night after meals, and then rinsing with clean water for 8 weeks.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy males and females aged 25 to 45 years (both included);
2.Individuals with generally healthy oral tissues, without inflammation, redness, or pain, as confirmed by a comprehensive dental examination. This includes no current or recent (within the last 6 months) periodontal treatment or significant oral diseases;
3.Participants with perceived teeth discoloration and need to improve teeth whiteness and overall oral hygiene;
4.Participants with mild and moderate plaque with plaque index 2-4;
5.Participants who have all incisors and canines in the upper and lower jaw;
6.Individuals in good general health without any systemic conditions or medications that could affect oral health or interfere with the study treatments;
Participants who provide written informed consent to participate in the study and comply with all study procedures and requirements. 
 
ExclusionCriteria 
Details  1.Participants with A1, B1 and C1 shade on Vita Shade scale
2.Individuals with current alcohol or tobacco use
3.Known sensitivity or history of significant adverse effects to any of the investigational products
4.Significant unstable or uncontrolled medical condition which may interfere with a participant participation in the study
5.Participated in tooth stain removal trials in the least 3 months;
6.Individuals who are unable to adhere to the study protocol or have conditions that may interfere with compliance, including cognitive impairments or language barriers;
7.Participants using antibiotics or other medications that could affect oral health or interfere with the study results;
8.Participants involved in concurrent studies with similar assessments or interventions;
9.Participants experiencing severe dry mouth (xerostomia);
10.Participants with chronic bad breath (halitosis) due to treatment or any medical condition;
11.Participants with any known hypersensitivity of charcoal containing oral care products. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Changes in teeth whitening assessed by VITA Shade Scale at screening, week 4, and week 8.
2.Changes in Investigational Product on Plaque Index (PI) at screening, week 4, and week 8. 		 Screening, week 4, and week 8. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in Macpherson’s Modified Stain Index at baseline, week 4 and week 8.
2.Changes in Organoleptic Scoring Scale (OSS) at baseline, week 4, and week 8.
3.Compliance and tolerability will be assessed at week 4 and week 8. 		 Screening, week 4, and week 8. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) 24/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This clinical study is designed to rigorously evaluate the efficacy of Activated Charcoal Pro+ toothpaste in improving tooth color and reducing plaque accumulation over an 8-week period. Despite the growing popularity of charcoal-based dentifrices, there is limited clinical evidence supporting their benefits beyond cosmetic effects. This study aims to address this gap by using validated indices such as the VITA Shade Scale for tooth color assessment, along with the Plaque Index and Macpherson’s Modified Stain Index, to quantify changes in oral hygiene status. The Organoleptic Scoring Scale will further evaluate breath quality, providing a holistic assessment of oral health. Continuous safety monitoring, including adverse event reporting and assessments of compliance and tolerability, will ensure a comprehensive safety profile. The findings will contribute valuable evidence regarding the clinical utility, safety, and potential role of activated charcoal-based toothpaste in daily oral hygiene practices, supporting evidence-based recommendations for both consumers and dental professionals.

 
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