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CTRI Number  CTRI/2025/06/088713 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study Comparing Two Gels to Treat Gum Diseases 
Scientific Title of Study   A prospective multicentric randomized active controlled open label study evaluating the efficacy and safety of Lignocaine gel with Chlorhexidine gluconate gel in the management of gingivitis and or Stage I and II periodontitis 
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 Lakshmi Balraj 
Designation  Chief Officer & Head Research 
Affiliation  Indian Dental Association 
Address  Research Department, Non clinical division, Room Number -3, 3rd Floor DPG House Unit No 3 A & B Zone 1 88 C Old Prabhadevi Road

Mumbai
MAHARASHTRA
400025
India 
Phone  09820094499  
Fax    
Email  drlakshmi@idrf.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Lakshmi Balraj 
Designation  Chief Officer & Head Research 
Affiliation  Indian Dental Association 
Address  Research Department 3rd Floor DPG House Unit No 3 A & B Zone 1 88 C Old Prabhadevi Road 88 C Old Prabhadevi Road

Mumbai
MAHARASHTRA
400025
India 
Phone  919742504911  
Fax    
Email  drlakshmi@idrf.org.in  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Kunjan 
Designation  Research Assistant 
Affiliation  Indian Dental Association 
Address  Research department 3rd Floor DPG House Unit No 3 A & B Zone 1 88 C Old Prabhadevi Road

Mumbai
MAHARASHTRA
400025
India 
Phone  08788172710  
Fax    
Email  pooja_k@ida.org.in  
 
Source of Monetary or Material Support  
J B CHEMICALS & PHARMACEUTICALS LTD Neelam Centre , B Wing, Hind Cycle Road, Mumbai 400018 
 
Primary Sponsor  
Name  JB Pharmaceuticals 
Address  Cnergy IT Park Unit A2 3rd Floor & Unit A 8th Floor Appa Saheb Marathe Marg Prabhadevi Mumbai 400018  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
No Secondary Sponsors  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aditya Sinha  K D Dental College & Hospital  Department of Periodontology Clinical Division Room number 301 Mathura Delhi Mathura Road National Highway 19 Post Office Chhatikara Mathura 110001
Mathura
UTTAR PRADESH 		 97605 78995

adityasinhamds@gmail.com  
Dr Yamuna Marella   Sibar Institute of Dental Sciences  Department of Periodontology, Clinical Division, Room Number 302, Takkellapadu Guntur Andhra Pradesh 522509
Guntur
ANDHRA PRADESH 		 81427 47691

dryamunamarellaperio@sids.ac.in 
Dr Sharayu Dhande   Sinhgad dental college and hospital   Department of Periodontology Clinical Division Room number 303 Vadgaon bk Pune 411041
Pune
MAHARASHTRA 		 77986 32770

drsharayudhande1595@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee of K D Dental College and Hospital  Approved 
Institutional Ethics Committee of Sibar Institute of Dental Sciences   Approved 
Institutional Ethics Committee of Sinhgad dental college and hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K054||Periodontosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lignocaine (2% w/w) +Metronidazole (1% w/w) +Chlorhexidine (1% w/w) gel   Duration is 21 days 
Comparator Agent  Chlorhexidine gluconate gel (1% w/w)  Duration is 21 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Gingivitis and/or Stage I or Stage II periodontitis
And
Presence of mild to moderate discomfort which can manifest as pain

2 gingival tenderness on palpation or a general sense of unease in the affected
area.

3 The pain may range from mild discomfort during routine oral functions such as chewing brushing or speaking to more persistent spontaneous pain at
rest.

Other mandates

1 Male or Female aged 18–60 years

2 Willingness to adhere to the study protocol and provide informed consent 
 
ExclusionCriteria 
Details  1 Known allergy to any component of the gels.

2 History of Smoking

3 Use of systemic antibiotics within the last 30 days.

4 Pregnant or lactating women.

5 Grade 3 periodontitis.

6 Aggressive periodontitis.

7 Acute Necrotizing Ulcerative Periodontitis (ANUP)

8 Acute Necrotizing Ulcerative Gingivitis (ANUG)

9 History of systemic diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome
Improvement in Gingival Index

Primary Outcome
Improvement in Gingival Index

Co-primary Outcome
Reduction in Probing Pocket Depth

Secondary Outcomes
Reduction in Plaque Index
Reduction in Bleeding on Probing
Reduction in Pain
Increased Treatment Satisfaction
Monitoring of Serious Adverse Events
Reduction in NSAID Use in Control Group
Co-primary Outcome
Reduction in Probing Pocket Depth 		 Day 0
Baseline assessment

Informed consent

Medical history and oral hygiene habits

Clinical exam: GI, PPD, PI, BOP, Pain

Randomization to test or control group

Day 10
First follow-up

Reassessment: GI, PPD, PI, BOP, Pain

Adverse event monitoring

Day 21
Final follow-up

Final assessment: GI, PPD, PI, BOP, Pain

Treatment satisfaction questionnaire

NSAID usage evaluation in control group

Adverse event documentation








 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="208"
Sample Size from India="208" 
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 
Date of First Enrollment (India)   17/07/2025 
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   This multicentric, randomised, open label clinical trial evaluates the efficacy and safety of a combination gel containing lignocaine metronidazole and chlorhexidine compared to standard to standard chlorhexidine gel in managing gingivitis and stage I/II periodontitis. A total of 208 adult participants are randomized onto two groups. Assessments are conducted at baseline, Day 10, and Day 21. The study focuses on the improvements in gingival health, clinical parameters, symptom relief, patient satisfaction and safety. If effective the combination gel could offer a simplified and more comfortable treatment alternative for early periodontal conditions 
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