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CTRI Number  CTRI/2024/04/065108 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 30/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Coconut husk extract as an oral mouthrinse in Gingivitis patients.  
Scientific Title of Study   Clinical evaluation of the Coconut husk extract as an oral mouthrinse as an adjunct to scaling in Gingivitis patients. A Randomized Control 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 Tejashree Agawane 
Designation  Post graduate student  
Affiliation  MGVs KBH Dental college and hospital  
Address  301, dept of periodontology MGV KBH Dental College Panchavati Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  8828454762  
Fax    
Email  tejashreeagawane@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Triveni Kale  
Designation  Guide and Professor 
Affiliation  MGVs KBH Dental college and hospital  
Address  301 dept of periodontology MGV KBH Dental college Panchavati Nashik


MAHARASHTRA
422003
India 
Phone  8552011711  
Fax    
Email  triv19792018@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tejashree Agawane 
Designation  Post graduate student  
Affiliation  MGVs KBH Dental college and hospital  
Address  301 dept of periodontology MGV KBH Dental college Panchavati Nashik


MAHARASHTRA
422003
India 
Phone  8828454762  
Fax    
Email  tejashreeagawane@gmail.com  
 
Source of Monetary or Material Support  
Not applicable  
 
Primary Sponsor  
Name  MGV KBH Dental college 
Address  vaishnavi park, Panchavati Nashik - 422003 
Type of Sponsor  Private medical college 
 
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 Tejashree Agawane  MGV KBH Dental College  301 department of periodontology
Nashik
MAHARASHTRA 		 8828454762

tejashreeagawane@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGVs KBH Dental College - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Coconut husk extract   0.75% alcoholic solution twice daily for 15 days 10ml for 15sec 
Comparator Agent  distilled water  distilled water was obtained from medical store twice daily for 15 days 10ml for 15sec 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients with age group between 18-40 years
Patient with Dental biofilm induced gingivitis.
Patients with natural 20 functional teeth.
 
 
ExclusionCriteria 
Details  Patients who are medically compromised such as diabetic, Immunocompromised or bleeding disorder.
Patients with smoking habit.
Pregnant or lactating women.
Patients who had received any chemotherapeutic mouth rinse or oral irrigation during past 6 months.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque Index - Silness and Loe, 1964 (PI)
Gingival Index - Loe and Silness; 1963 (GI)
Sulcus Bleeding Index – Muhlemann H.R and Son, 1997
 		 baseline, 8th day, 15th day  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   11/04/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Aim - To clinically evaluate the efficacy of Coconut husk extract as an oral mouth-rinse as an adjunct to scaling in the gingivitis patient.

Objective - To evaluate and compare the Plaque Index (PI), Gingival Index (GI), Sulcus Bleeding Index (SBI)  using coconut husk extract and distilled water  as mouth-rinse in gingivitis patients after 8th and 15th days.

Introduction - Gingivitis caused due to infection and biofilm.The interest in the plants with antibacterial and anti-inflammatory activity has increased now days to treat various dental diseases as consequences of current problems associated with the conventional agents. Coconut husks have been used for maintaining oral hygiene for many years, but there is no scientific evidence for the beneficial effects of this plant material, with respect to antimicrobial properties against common cariogenic bacteria. The phytochemical screening of C. nucifera has reported that this plant material is rich in alkaloids, flavonoids, catechins, and epicatechin, together with condensed tannins, which confer on it potent antimicrobial properties in cariogenic bacteria.

Materials & Methods - 30 patients with biofilm induced gingivitis were divided into 2 groups. Group 1 – coconut husk extract mouth-rinse, Group 2 – distilled water mouth-rinse (placebo). The mouthwash was prescribed after scaling for 15 days. Patients were instructed to use 15ml of mouth-rinse at a time for 2 times daily. Parameters evaluated were Plaque Index, Gingival Index, and Sulcus Bleeding Index at baseline, 8 and 15th day.

Results - Coconut husk extract showed significant reduction  Plaque Index, Gingival Index, and Sulcus Bleeding Index at 8 and 15th day  as compared to placebo.

Conclusion - Coconut husk extract mouth-rinse can be used as an adjunct to scaling in Biofilm Induced Gingivitis.

 
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