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CTRI Number  CTRI/2018/03/012689 [Registered on: 21/03/2018] Trial Registered Prospectively
Last Modified On: 20/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Coconut Oil Therapy as supplementary to Scaling in Diabetic patients with Gum Disease.  
Scientific Title of Study   Evaluation of Efficacy of Coconut Oil Pulling Therapy as an adjunct to Scaling in Diabetic patients with Chronic Gingivitis – A Randomised Controlled Clinical Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shraddha Kode 
Designation  Post-graduate student 
Affiliation  Nair Hospital Dental College 
Address  Department of Periodontics, 202, Second floor, Nair Hospital Dental College, Dr. A.L.Nair Road, Opposite Maratha Mandir, Mumbai Central, Mumbai - 08.

Thane
MAHARASHTRA
400605
India 
Phone  9773752150  
Fax    
Email  kshraa24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praneeta Kamble 
Designation  Associate Professor 
Affiliation  Nair Hospital Dental College 
Address  Department of Periodontics, 202, Second floor, Nair Hospital Dental College, Dr. A.L.Nair Road, Opposite Maratha Mandir, Mumbai Central, Mumbai - 08.

Mumbai
MAHARASHTRA
400605
India 
Phone  9820263468  
Fax    
Email  drpraneetakamble@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SHRADDHA KODE 
Designation  POST-GRADUATE STUDENT 
Affiliation  Nair Hospital Dental College 
Address  Department of Periodontics, 202, Second floor, Nair Hospital Dental College, Dr. A.L.Nair Road, Opposite Maratha Mandir, Mumbai Central, Mumbai - 08.

Thane
MAHARASHTRA
400605
India 
Phone  9773752150  
Fax    
Email  kshraa24@gmail.com  
 
Source of Monetary or Material Support  
Self Sponsored Coconut Oil And Hexidine Mouthwash Sponsored by ICPA Company, Mumbai 
 
Primary Sponsor  
Name  Dr Shraddha Kode 
Address  S/3 A CHITRALEKHA, VIKRAM NAGAR, KALWA(W). DIST - THANE 400605. 
Type of Sponsor  Other [SELF SPONSORED] 
 
Details of Secondary Sponsor  
Name  Address 
ICPA COMPANY MUMBAI  216-219, Adarsh Industrial Estate, Sahar Road, Chakala, Andheri (East), Mumbai – 400099. Phone : 40065305 / 40065306 / 40065307 Fax : 28216928  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Shraddha Kode  Nair Hospital Dental College  Department of Periodontics, 202, Second floor, Nair Hospital Dental College, Dr. A.L.Nair Road, Opposite Maratha Mandir, Mumbai Central, Mumbai - 08.
Mumbai
MAHARASHTRA 
9773752150

kshraa24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-NHDC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  CONTROLLED DIABETIC PATIENTS WITH CHRONIC GINGIVITIS IN THE AGE GROUP OF 25-70 YEARS WITH HbA1c LEVELS LESS THAN 7,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COCONUT OIL and Scaling and Root planing (SRP)   The test group will be instructed to perform oil pulling with coconut oil, one tablespoon of coconut oil on an empty stomach first thing in the morning for the next 15 days. The coconut oil sachets will be provided to them. One tablespoon of coconut oil is sipped, sucked, and pulled between the teeth for 10 to 15 minutes. The viscous oil turns thin and milky white. This oil should not be swallowed as it contains bacteria and toxins. Oil pulling therapy should preferably done on an empty stomach in the morning, followed by brushing of the teeth. 
Comparator Agent  HEXIDINE MOUTHWASH and Scaling and Root planing (SRP)   Scaling and Root planing (SRP) will be done. The Control group will be instructed to rinse with 0.2% CHX mouthwash for 30 seconds, twice a day for next 15 days. Chlorhexidine mouth wash will be provided to them. 
Comparator Agent  Scaling and Root planing (SRP)   Scaling and Root planing (SRP) will be done only at baseline. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age group between 25-70 years.
2. Patients with controlled diabetes (on oral hypoglycemic drugs) with glycosylated haemoglobin (HbA1c) levels < 7
3. Patients with chronic gingivitis
4. Patients with minimum of 20 teeth.
5. Patients who have not received any type of periodontal therapy for the past 6 months
 
 
ExclusionCriteria 
Details  1. Patients on insulin therapy
2. Patients suffering from any other systemic disease or with compromised immune system.
3. Patients with a known history of drug allergy
4. Patients taking any drug known to cause gingival enlargement
5. Patients taking any immuno-suppressive drugs like corticosteroids.
6. Pregnant and/or lactating mothers.
7. Patients with any bleeding disorders.
8. Patients on anticoagulant therapy.
9. Patients with smoking and tobacco chewing habits.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gingival index (G.I.) (Loe and Silness, 1963)
 
BASELINE AND 15DAYS POST TREATMENT 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index (P.I.) (Tureskey-Gilmore-Glickman Modification Of Quigley Hein, 1970)  BASELINE AND 15DAYS POST TREATMENT 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   24/03/2018 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

INTRODUCTION:

            Gingivitis is one of the most commonly found oral diseases. It is the initial stage of periodontal disease that occurs due to the colonization of plaque microorganisms on the tooth. Antibacterial mouthrinses like Chlorhexidine are used as an adjunct to mechanical plaque control. Chlorhexidine is considered as the “gold standard” but there are a few disadvantages associated with the long term use like altered taste sensation and staining of the teeth1. There is a requirement for a long term, home based remedy which is also economical.

            Oil pulling or oil swishing, is a traditional Indian folk remedy that involves swishing oil in the mouth for oral and systemic health benefits. Oil pulling has been used extensively as part of alternative medicine for many years to prevent decay, oral malodour, bleeding gums, dryness of the throat, cracked lips and for strengthening teeth, gums, and the jaw.1 Oil pulling therapy can be done using edible oils like sunflower or sesame oil.

The modern version of oil pulling was coined by Ukranian physician Dr. Karach during 1990’s in Union of Soviet Socialist Republics (USSR), after he experimented swishing oil in the above-mentioned method and cured himself from a blood disease. He further studied it, systematized it and propagated it across the world. Dr. Karach says: “With the oil therapy, I healed my chronic blood disease of 15 years. With the use of this therapy; I healed within 3 days of an acute arthrosis that had forced me to lie in bed.”2

 

Various oils used for swishing 3-7

1. Coconut oil

2. Corn oil

3. Rice bran oil

4. Palm oil

5. Sesame oil

6. Sunflower oil

7. Soya bean oil.

Coconut oil has a unique role in the diet as an important physically functional food. What makes coconut oil different from most other dietary oils are the basic building blocks, or fatty acids, making up the oil. The predominant composition of coconut oil is a medium chain fatty acid, whereas the majority of common edible fats in our diet are composed almost entirely of long chain fatty acids. This influences the physical and chemical properties of the oil.

Coconut oil contains 92% saturated acids, approximately 50% of which is lauric acid Recently, results from many studies revealed that the monolaurin, the monoglycerides of lauric acid from coconut oil had antimicrobial activity against various Gram-positive and Gram-negative organisms, including Escherichia vulneris, Enterobcater spp.8  Helicobacter pylori,9  Staphylococcus aureus,10  Candida spp., including Candida albicans, Candida glabrata, Candida tropicali, Candida parapsilosis, Candida stellatoidea and Candida krusei,11  as well as enveloped viruses though the exact antibacterial mechanism of the action of coconut oil is still unclear, it was hypothesized that monolaurin and other medium chain monoglycerides had the capacity to alter bacterial cell walls, penetrate and disrupt cell membranes, inhibit enzymes involved in energy production and nutrient transfer, leading to the death of the bacteria.7

 

Mechanism of action

The oil acts as a cleanser. When you put it in your mouth and work it around your teeth and gums it “pulls” out bacteria and other debris. Oil pulling has a very powerful detoxifying effect. Toxins are pulled from the body the very first time you try it.

Swishing process makes oil thoroughly mixed with saliva. Swishing activates the enzymes and the enzymes draw toxins out of the blood. The oil must not be swallowed, for it has become toxic. As the process continues, the oil gets thinner and white. If the oil is still yellow, it has not been pulled long enough. It is then spit from the mouth, the oral cavity must be thoroughly rinsed and mouth must be washed thoroughly.12

The mechanisms of oil-pulling action are not known. It has been proposed, however, that the viscosity of the oil can inhibit bacterial adhesion and plaque coaggregation.13 The other possible mechanism might be the saponification process that occurs as a result of alkali hydrolysis of oil by bicarbonates in saliva.14    

            Limited literature or scientific proof is available to accept oil pulling therapy as a preventive adjunct to scaling and root planing. Therefore, the aim of the present, clinical study was to clinically evaluate the anti-plaque effect of coconut oil pulling and its influence on chronic gingivitis as compared to chlorhexidine mouth wash in diabetic patients.

AIM OF STUDY:

To introduce a natural ingredient that effectively reduces inflammation in Diabetic patients with Chronic Gingivitis

OBJECTIVES OF THE STUDY:

1.    To evaluate the efficacy of Coconut Oil as an adjunct to Scaling in Diabetic patients with Chronic Gingivitis.

2.    To compare the efficacy of Coconut Oil with Chlorhexidine mouthwash in Diabetic patients with Chronic Gingivitis post scaling.

 
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