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CTRI Number  CTRI/2025/06/089764 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Testing the Benefits of a Herbal drug for oral care 
Scientific Title of Study   Efficacy of liquorice-infused chitosan local drug delivery system in chronic periodontitis – a 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  Isvarya ES 
Designation  Post graduate residence 
Affiliation  KSR Institiute of Dental Science And Research 
Address  Room no 3 Dept of periodontology KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi - 637215 Tamil Nadu

Namakkal
TAMIL NADU
637215
India 
Phone  09361645151  
Fax    
Email  settuishu837@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Esther Nalini H 
Designation  Professor 
Affiliation  KSR Institiute of Dental Science And Research 
Address  Room no 3 Dept of periodontology KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi - 637215 Tamil Nadu

Namakkal
TAMIL NADU
637215
India 
Phone  09486274005  
Fax    
Email  hesthernalini78@ksridsr.edu.in  
 
Details of Contact Person
Public Query  
Name  ISVARYA ES 
Designation  Post graduate residence 
Affiliation  KSR Institiute of Dental Science And Research 
Address  Room no 3 Dept of periodontology KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi - 637215 Tamil Nadu

Namakkal
TAMIL NADU
637215
India 
Phone  09361645151  
Fax    
Email  settuishu837@gmail.com  
 
Source of Monetary or Material Support  
Room no 3 Dept of periodontology KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi - 637215 Tamil Nadu  
 
Primary Sponsor  
Name  Isvarya E S 
Address  Room no 3 Dept of periodontology KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi - 637215 Tamil Nadu  
Type of Sponsor  Other [Self sponsored] 
 
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 
Isvarya ES  KSR Institiute of Dental Science And Research  Room no 3 Dept of periodontology KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi - 637215 Tamil Nadu
Namakkal
TAMIL NADU 		 09361645151

settuishu837@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KSR INSTITUTIONAL ETHICS COMMITEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  CHRONIC PERIODONTITIS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2 GROUPS  6 MONTHS  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  30 to 60 years old systemically healthy participants. Chronic periodontitis patients with at least one site with a pocket depth of more than 5mm and a CAL of 3 to 4 mm.
 
 
ExclusionCriteria 
Details  History of systemic disease. Smokers and tobacco chewers. Pregnant and lactating females. Periodontal therapy within 6 months. History of Antibiotics for the past 3 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To develop a liquorice coated chitosan chip.
To analyse the cytotoxicity, composition and drug release of liquorice coated chitosan chip.
 		 0 days to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical effectiveness of liquorice infused chitosan chip when used as an adjunct to SRP in patients with chronic periodontitis.
 		 0 DAYS TO 3 MONTHS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/07/2025 
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="6"
Days="15" 
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   Evaluating the efficacy of a liquorice-infused local drug delivery (LDD) chip as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis. The study is designed as a randomized controlled clinical trial using a split-mouth design, where 20 patients with chronic periodontitis provide both test and control sites. The test group receives SRP along with the liquorice-coated chitosan chip, while the control group receives SRP along with chitosan chip. The liquorice extract is prepared using the Soxhlet extraction method and infused into a chitosan membrane to form the chip. In vitro analyses include FTIR and gas chromatography for composition, cytotoxicity testing using human fibroblast cell lines, and drug release studies using the dialysis membrane method. Clinically, the study evaluates parameters such as the gingival index (GI), plaque index (PI), probing pocket depth (PPD), and clinical attachment level (CAL) before and after treatment. This research aims to develop a natural, biocompatible, and effective adjunctive therapy to improve periodontal treatment outcomes. 
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