| 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
|
|
|
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
|
|
|
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 |