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CTRI Number  CTRI/2024/05/067858 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 21/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Other 
Public Title of Study   Comparing The Effects Of Virgin Coconut Oil Pulling And Chlorhexidine Mouthwash On Gingivitis 
Scientific Title of Study   Comparative Evaluation Of Salivary Anaerobic Microbial Count In Plaque Induced Gingivitis In Subjects Using Virgin Coconut Oil Pulling And Chlorhexidine Mouthwash 
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 K R  
Designation  UG student 
Affiliation  Mar Baselios Dental College 
Address  Department of Periodontics and Implantology Room No:11 Mar Baselios Dental College Nellikuzhi- Thangalam road Kothamangalam Ernakulam

Ernakulam
KERALA
686691
India 
Phone  9446427231  
Fax    
Email  lakshmikunnathully@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Lekshmi A J 
Designation  Assistant Professor 
Affiliation  Mar Baselios Dental College 
Address  Department of Periodontics and Implantology Room No:11 Mar Baselios Dental College Nellikuzhi-Thangalam road Kothamangalam Ernakulam

Ernakulam
KERALA
686691
India 
Phone  9495887944  
Fax    
Email  lekshmiaj@mbdc.edu.in  
 
Details of Contact Person
Public Query  
Name  DR Lakshmi K R  
Designation  UG student 
Affiliation  Mar Baselios Dental College 
Address  Department of Periodontics and Implantology Room No:11 Mar Baselios Dental College Nellikuzhi-Thangalam road Kothamangalam Ernakulam

Ernakulam
KERALA
686691
India 
Phone  9446427231  
Fax    
Email  lakshmikunnathully@gmail.com  
 
Source of Monetary or Material Support  
Mar Baselios Dental College Nellikuzhi-Thangalam road Kothamangalam Ernakulam Kerala India 686691 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Lakshmi K R  Mar Baselios Dental College  Department of Periodontics and Implantology Room No:11 Mar Baselios Dental College Nellikuzhi-Thangalam road Kothamangalam Ernakulam Kerala India
Ernakulam
KERALA 		 9446427231

lakshmikunnathully@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Review Committee, Mar Baselios Dental College  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  Chlorhexidine mouthwash Virgin coconut oil  15 subjects are asked to swish(orally)10ml of 0.12% of chlorhexidine mouthwash twice daily after brushing for 15 days. Next 15 subjects are advised to perform oil pulling(orally) using 10ml of virgin coconut oil once daily before brushing for 15 days. 
Comparator Agent  Salivary anaerobic microbial count  Saliva samples are collected using swabs from 30 subjects and then salivary anaerobic microbial count will be determined using RT-PCR test.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Systemically healthy individuals within the age group 18 – 30 years diagnosed with chronic gingivitis
Subjects willing to participate in the study

 
 
ExclusionCriteria 
Details  History of oral prophylaxis within six months prior to the start of the study.
The use of antibiotics or mouthwashes within three months prior to the start of the study.
Use of tobacco
Ongoing fixed orthodontic therapy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in salivary anaerobic microbial count in both subjects using chlorhexidine mouthwash and coconut oil pulling  Time points : 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the gingival status of both subjects using chlorhexidine mouthwash & coconut oil pulling  1 month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/06/2024 
Date of Study Completion (India) 05/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/08/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
•A total of 30 subjects with chronic plaque -induced mild to moderate gingivitis in the age group 18 to 30 years will be recruited and they will be divided into group A and Group B each with 15 subjects.
•Group A subjects will be advised to perform virgin coconut oil pulling (The Happy Grove Virgin Coconut Oil, KCK Agroproducts )  and group B will be advised to use Chlorhexidine Gluconate 0.12% solution (Periogard Mouthwash, Colgate Palmolive) for 15 days as an adjunct to routine tooth brushing.
•Subjects will be recalled after 15 days and oral prophylaxis will be performed and shall be instructed to discontinue mouthwash and oil pulling.
•Gingival and Plaque indices will be estimated at the three visits (baseline,15 days, and 30 days). Salivary anaerobic microbial counts also shall be estimated for both the study groups using RT-PCR during the three visits.
RESULTS
      Based on statistical results using t test coconut oil pulling and  chlorhexidine mouthwash have comparable effects on gingival status. So, we conclude that oil pulling using coconut oil is an effective adjuvant oral hygiene practice in reducing severity of mild to moderate plaque induced gingivitis along with routine oral hygiene measures. Coconut oil pulling could be a potential alternative to chlorhexidine mouthwash for long term use.

 
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