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
|
|
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.â€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. |