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CTRI Number  CTRI/2023/05/052953 [Registered on: 19/05/2023] Trial Registered Prospectively
Last Modified On: 18/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   LOCAL DRUG DELIVERY OF GEL CONTAING EXTRACTS OF MURRAYA KOENIGII COMPARED WITH CHLORHEXIDINE GEL ALONG WITH SCALING AND ROOT PLANING FOR TREATMENT OF MODERATE CHRONIC PERIODONTITIS 
Scientific Title of Study   COMPARATIVE EVALUATION OF LOCAL DRUG DELIVERY GEL CONTAING EXTRACTS OF MURRAYA KOENIGII WITH THAT OF CHLORHEXIDINE GEL AS AN ADJUNCT TO SCALING AND ROOT PLANING IN MANAGEMENT OF MODERATE CHRONIC PERIODONTITIS : A RANDOMIZED CONTROLLED TRIAL. 
Trial Acronym  MURRAYA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prajakta Heda 
Designation  periodontist 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital 
Address  Department of Periodontology, room no: 05, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Hingna, Nagpur
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
441110
India 
Phone  08329561472  
Fax    
Email  hedabraj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Grishmi Niswade 
Designation  periodontist 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital 
Address  Department Of Periodontology, Room no: 05 Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Hingna, Nagpur
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
441110
India 
Phone  8149914078  
Fax    
Email  grishmi.niswade@sdk-dentalcollege.edu.in  
 
Details of Contact Person
Public Query
 
Name  Prajakta Heda 
Designation  periodontist 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital 
Address  Department of Periodontology, Room no : 05, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Hingna, Nagpur
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
441110
India 
Phone  08329561472  
Fax    
Email  hedabraj@gmail.com  
 
Source of Monetary or Material Support  
Department of periodontology, room no: 05, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Hingna, Nagpur 
 
Primary Sponsor  
Name  Swargiya Dadasaheb Kalmegh Smruti dental College And hospital 
Address  Swargiya Dadasaheb Kalmegh Smruti dental College And hospital, Hingna Nagpur 
Type of Sponsor  Research institution and hospital 
 
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 Prajakta Heda  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital  Department of Periodontology, room no: 05, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA 
08329561472

hedabraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Swargiya Dadasaheb Kalmegh Smruti dental college and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine gel  Chlorhexidine gel will be introduced into the periodontal pockets with the help of syringe and adhere to the adjacent root surfaces records will be recorded at baseline, 30th day and 90th day 
Intervention  Murraya koenigii gel  Murraya koenigii gel will be introduced into the periodontal pockets with the help of syringe and adhere to the adjacent root surfaces records will be recorded at baseline, 30th day and 90th day 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with pocket probing depth ≥ 5mm with localized/generalized periodontitis not indicated for surgery. 
 
ExclusionCriteria 
Details  Patients who received any antibiotic therapy in the last 6 months.
Patients who received any chemotherapeutic mouth rinses/oral irrigation during the past 1 month.
Patients who received any surgical or nonsurgical periodontal therapy, 6 months prior to the start of the study.
Patients with allergies to any of medications which will be used in the study.
Pregnant or Lactating women.
Patients who are smokers/alcoholic. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
efficacy of Murraya Koenigii gel in patients with Moderate Chronic Periodontitis as an adjunct to scaling and root planing.  30th day, 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
efficacy of Murraya Koenigii gel over chlorhexidine gel in patients with Moderate Chronic Periodontitis as an adjunct to scaling and root planing.  30th day, 90th day 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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/ Phase 4 
Date of First Enrollment (India)   30/05/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Chlorhexidine (CHX) is one of the most effective antimicrobial agents for plaque control. Local side effects associated with the use of chlorhexidine induce tooth staining, alteration of taste sensation and costly to the patient. Despite the immense benefit of chlorhexidine gluconate as an antiplaque agent, the search continues for active ingredients that could prevent dental inflammation without affecting the biological equilibrium within the oral cavity. Currently, use of herbal products in dentistry is increasing. This can be attributed to their ease of availability, low cost, and fewer side effects. One such herb with wide medicinal importance is Murraya Koenigii, commonly known as curry leaves. It is well established to have antimicrobial, antiemetic, antidiabetic, antiulcer, antioxidative, cytotoxic, and phagocytic activity. Chlorophyll component in curry leaves has been reported as an anticariogenic agent and it also helps to reduce halitosis. The antibacterial effect of Murraya Koenigii extract has been proven to be effective against an array of Gram-positive, Gram-negative periodontal pathogens. Therefore, Murraya Koenigii extract mouth rinse has been used as an alternative to chlorhexidine mouthwash.

To the best of our knowledge no such study has been carried out comparing the use of Murraya Koenigii in gel form as a local drug delivery agent in the management of Chronic periodontitis. Therefore, the aim of this study will be to assess the efficacy of Murraya Koenigii gel as a local delivery agent in the management of moderate chronic periodontitis 
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