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CTRI Number  CTRI/2025/07/091432 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating Gum Forte Gel Homeopathic Toothpaste for Early Stage Gum Disease A Clinical Trial on Patient Outcomes  
Scientific Title of Study   Efficacy of Gum Forte Gel Homoeopathic Toothpaste on Stage 1- Grade B periodontitis patients: A single center, randomized controlled clinical 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 Divya Kumar 
Designation  Senior lecturer 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Department of periodontology Sri Ramachandra Dental college No1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu India Chennai TAMIL NADU India

Chennai
TAMIL NADU
600116
India 
Phone  9884472275  
Fax    
Email  divyakumar@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Divya Kumar 
Designation  Senior lecturer 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Department of periodontology Sri Ramachandra Dental college No1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu India Chennai TAMIL NADU India

Chennai
TAMIL NADU
600116
India 
Phone  9884472275  
Fax    
Email  divyakumar@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nitia V Mohan  
Designation  Medical Director and administration 
Affiliation  Fourrts India laboratories private limited 
Address  No 1 Fourrts avenue Annai Indira nagar okkiyam thoraipakkam chennai Chennai TAMIL NADU India

Chennai
TAMIL NADU
600097
India 
Phone  914443441880  
Fax    
Email  dmv@fourrts.com  
 
Source of Monetary or Material Support  
Fourrts India Laboratories Pvt Ltd 
 
Primary Sponsor  
Name  Fourrts India Laboratories Pvt Ltd 
Address  Plot No1 Fourrts Avenue Annai Indira Nagar Okkiyam Thoraipakkam Chennai 600097 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Divya Kumar  Sri Ramachandra Hospital   Department of periodontology Sri Ramachandra Dental college No1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu India Chennai TAMIL NADU
Chennai
TAMIL NADU 		 09884472275

divyakumar@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sairam homoeopathy medical college IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Arm   Subjects will use their regular toothpaste as standard of care for 12 weeks study periods 
Intervention  Gum Forte Gel Homoeopathic Toothpaste   Gum Forte Gel Homoeopathic toothpaste Dosage is Brush twice a day morning and night Duration 12 weeks study period  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults 18 to 60 years
Clinical diagnosis of Stage 1 Grade B periodontitis
Ability to provide informed consent and comply with study protocols
till the end
Intent to develop the habits of cleaning teeth twice a day with flat end
soft bristles toothbrush as mentioned
PPD 4mm
CAL 1 2mm 
 
ExclusionCriteria 
Details  Patients on anticoagulants therapy
Habit of smoking or Chewing tobacco
Patients with the history of antibiotic prophylaxis with in the past 1
month
Patients who underwent scaling with in the past 1 month
Patients undergoing orthodontic treatments
Pregnant and lactating women  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of
periodontitis measured by bleeding on probing BOP probing pocket
depth PPD Clinical attachment level CAL periodontal inflamed
surface area PISA Gingival index simplified OHI plaque index and
comprehensive periodontal examination
To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with
the help of Microbiologist  		 To evaluate the effectiveness of Gum Forte Gel Homoeopathic Toothpaste on treating stage 1 Grade B patients post non surgical management of
periodontitis measured by bleeding on probing BOP probing pocket
depth PPD Clinical attachment level CAL periodontal inflamed
surface area PISA Gingival index simplified OHI plaque index and
comprehensive periodontal examination
To evaluate the effectiveness of Gum forte gel homeopathic toothpaste on reducing Colony Forming bacterial load by quantitatively analyzing with
the help of Microbiologist  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the oral health related quality of life by oral health quality of
life index questionnaire OHRQoL
Overall Patient feedback 		 Visit 1 Baseline
Visit 2 4 th week
Visit 3 12 th week  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/08/2025 
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="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 will be initiated after obtaining written approval from the ethics
committees Patients in all age group with periodontitis will be enrolled if they
provide written informed consent and satisfy eligibility criteria and negative
for all exclusion criteria. Demographic medical history comorbidities and
other relevant clinical details will be recorded at baseline Patients will
undergo standard care as per routine practice and periodontal guideline
All participants who are diagnosed as Stage 1 - Grade B periodontitis will be enrolled in treatment group
 Subjects will use their regular toothpaste as standard of care in control group.
Inclusion criteria:
Homoeopathic Toothpaste after their dental checkup baseline scaling Root
planning and microbiological examination
During in person visits Periodontal parameters microbial examination and
clinical features will be done along with recording AEs concomitant
medications and treatment compliance from baseline till the study duration
After clinical assessments, General consultation will be done. The parameters
and outcomes will be assessed at 4 and 12 weeks along with refilling their
medication with monitoring their adherence to their respective treatment
 
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