Brief resume of the intended work



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6.


BRIEF RESUME OF THE INTENDED WORK


6.1 Need for the study:

In recent years Complementary and alternative medicine (CAM) is gaining popularity over conventional allopathic medicine due to reasons like products and practices used are natural and safe. Ayurveda is one of the popular and well accepted modality of Complementary and alternative medicine.1

Oil pulling, in CAM is an ayurvedic practice that involves swishing of oil in the mouth for oral and systemic health benefits.2 Oil pulling has been used extensively as a traditional Indian folk remedy for many years to prevent decay, oral malodour, bleeding gums, dryness of the throat, for strengthening teeth, gums, and the jaw.3In addition, this simple method is claimed to cure many diseases ranging from thrombosis, eczema, intestinal infection, and diabetes, to bronchitis and asthma.4

Scientific evidence shows that oil-pulling therapy could reduce the plaque index, modify gingival scores and the total oral bacteria count in gingivitis patients. Moreover, it can convert caries susceptibility from marked susceptibility to slight or moderate susceptibility.4 By oil pulling plaque scores have been reduced by 18-30% and gingivitis has reduce by 52-60%.5

Literature shows that Coconut oil exhibits antimicrobial activity against S. mutans and C. albicans. Sesame oil has antibacterial activity against S. mutans and sunflower oil has antifungal activity against C. albicans.

Inspite of all the advances in the field of health science, traditional healing methods still have a major role to play. These methods are born out of native wisdom of very high intellectualism. They are untouched and unspoiled. Oil pulling is one such method which improves the oral health and benefits various systems as well. Sufficient scientific research has not been carried out to evaluate the effect of oil pulling therapy on oral health and these needs to be explored.1

Extensive search of literature has shown no in-vivo studies conducted which have investigated the effect of oil pulling using more than one oil. Hence with this knowledge in background, the proposed study is planned to compare and evaluate the effect of oil pulling using four different oils on plaque and gingivitis and on salivary Streptococcus mutans, Lactobacilli and Candida albicans.

6.2 Review of literature:


An in vitro study was conducted in Bangkok, Thailand to investigate the effect of different oils on oral microorganisms in biofilm model formed by Streptococcus Mutans KPSK2, Lactobacillus casei ATCC 6363 and Candida albicans. The oils used were coconut oil, corn oil, rice bran oil, palm oil, sesame oil, sunflower oil and soy bean oil. It was found that coconut oil exhibited antimicrobial activity against S. mutans and C. albicans. Sesame oil had antibacterial activity against S. mutans whereas sunflower oil had antifungal activity against C. albicans.4

A randomized controlled clinical trial was conducted on twenty age-matched adolescent boys in Chennai, India with the aim to evaluate the effect of oil pulling therapy with sesame oil on reduction of Streptococcus mutans count in plaque and saliva in children using Dentocult SM Strips mutans, and to compare its efficacy with that of chlorhexidine mouthwash. Samples were collected from both groups after 24hours, 48 hours, 1 week and 2 weeks. It was concluded that reduction in S.mutans was seen in both oil pulling and chlorhexidine group.6

A randomized controlled triple blind study was done on a total of 20 age-matched adolescent boys with plaque-induced gingivitis in Chennai, India to evaluate effect of oil pulling with sesame oil and to compare its efficacy with chlorhexidine. Plaque index, modified gingival index were recorded at baseline. The plaque samples were also subjected to microbial analysis to measure total colony count of aerobic microorganisms. After 10 days, the study results showed statistically significant reduction in plaque index scores, modified gingival index scores. There was considerable reduction in total colony count of aerobic micro organism present in both groups.3

An in vivo study was conducted in Belgaum, India with an aim to assess the effect of oil pulling with refined sunflower oil on plaque and gingivitis.10 subjects aged 19-21 years performed Oil pulling along with their other oral hygiene measures for 45 days.Their plaque and gingival scores were assessed periodically at baseline, 15 days, 30 days and 45 days by modified Patient hygiene performance (PHP) and Gingival indices. Results showed significant reduction in plaque and gingival scores from baseline to 45 days.5




7.


6.3 Objectives of the study:

  1. To evaluate and compare effect of oil pulling on plaque scores using Modified Plaque Index and Gingival scores using Gingival Index.

  2. To evaluate and compare the effect of oil pulling using four different oils on Salivary Streptococcus mutans, Lactobacilli and Candida albicans.


MATERIAL AND METHODS

7.1 Source of data:

This proposed study will be conducted among subjects aged 14-16 years in residential Institute of Davangere City.


7.2 Method of collection of data (including sample size, inclusion criteria, exclusion criteria if any):

Study design:

Randomized controlled double blinded with parallel group study design.



Sample size and design:

Pilot study was conducted to check the palatability of the oils and the feasibility of the study.

Sample size is determined after pilot study, using the formula

n = 2tα2s2

d2

where t = theoretical value of t distribution with t value distribution

of 95%confidence interval = 2.13

s = pooled standard deviation based on previous studies =70.5

d = Minimum expected difference in the reduction of colonies=60

n = Sample size

Level of Significance =5%

Power of Study=1-β=80%


n= 2 x (2.13)2 x (70.5)2

(60)2

=12.6
So sample size is approximately 13

Based on the above calculations, to compensate for dropouts if any, a sample size of minimum 20 subjects in each group will be used thus totalling to effective sample size of 120.

They will then be randomly divided into 6 groups with 20 participants in each group based on inclusion and exclusion criteria.

The six study groups are,



Group I - Sesame oil

Group II - Sunflower oil

Group III - Coconut oil

Group IV - Olive oil

Group V - Chlorhexidine as positive control.

Group VI - Saline solution as negative control.
Procurement of the material:

Commercially available Refined sesame oil, sunflower oil, olive oil, coconut oil, saline solution, chlorhexidine mouth wash will be taken from local market of Davangere.


Inclusion criteria:

  1. Subject willing to participate in the study

  2. Subjects with mild to moderate plaque accumulation(score > 2)

  3. Subjects with mild to moderate gingivitis(score > 2)

  4. Presence of at least 20 natural permanent teeth.

Exclusion criteria:

  1. Subjects allergic to oils

  2. Subjects under antimicrobial therapy at least 1 month prior to the study and using mouth rinses containing substances with anti-inflammatory properties

  3. Subjects who are medically compromised.

Blinding and Masking:

Blinding and masking will be done to minimize concealment bias. Subjects and examiner will be blinded (double blind). Masking will be done to ensure that all oils will be dispensed with similar packing and labeling in bottles of similar size, shape and color.


Method of Examination:

Purpose of the study will be explained to the study subjects and demographic details will be taken in a proforma along with the written consent from all the subjects. Patient will be taught how to perform oil pulling.

The clinical examination will be conducted. All the subjects will be provided with their assigned products and instructed to use in morning prior to brushing.

The subjects will be examined for plaque scores and gingival scores at baseline and after 15 days,30 days and 45 days by a single, previously calibrated examiner using Modified Plaque Index7 (Turesky S., Gilmore N.D. and Glickman I. 1970) and Gingival Index8 (Loe H. and Silness J. 1963)


Oil pulling:

For oil pulling therapy, tablespoon oil is sipped, sucked, and pulled between the teeth for 10 to 15 minutes until the viscous oil turns thin and milky white. The subjects will be instructed not to swallow the oil. Oil pulling will be followed by brushing the teeth and it will be done on an empty stomach in the morning.3


Salivary sample collection:

Before assigning respective oils to groups, salivary samples will be collected at baseline in the morning before any oral hygiene practice. Unstimulated whole saliva will be collected in sterile container. Subjects will be instructed to let saliva collect in the floor of the mouth without swallowing


it for atleast 1 min and then to expectorate into the sterile container with the help of a sterile funnel. This procedure will be continued for a period of 5 minutes. Collected saliva will be transferred to the microbiology laboratory on the same day. Patients will be then instructed to perform oil pulling daily at the morning. Samples will again be collected after 15 days, 30 days and 45 days from the commencement of oil pulling. The saliva samples will be subjected for microbial analysis for quantification of Streptococcus Mutans, Lactobacillus and Candida albicans.
Salivary microbial analysis:

Salivary samples collected will be subjected to serial dilution. Streptococcus mutans will be quantified in the laboratory by culturing on Mitis Salivarius Bacitracin (MSB) agar. Salivary Lactobacilli will be quantified in the laboratory by culturing on Rogosa agar. Candida albicans will be quantified in the laboratory by culturing on Sabouraud’s Dextrose agar. The Colony Forming Units (CFU) of the organisms on the culture medium will be counted using a colony forming unit counter. The salivary microbial analysis and CFU counting will be done in the Department of Microbiology, J.J.M Medical College, Davangere.


Instruments and materials:

Mouth mirror, Explorer, Tweezers, Kidney tray, Gloves, Mouth mask, Periodontal probe, Disclosing agent, Culture media, Petridish, measurement beaker, containers and teaspoons.


Statistical analysis:

The results will be subjected for appropriate analysis. For comparison of Modified Plaque Index and Gingival Index scores at Baseline 15, 30, and 45 days One-way Analysis of Variance (ANOVA) for multiple group comparison followed by the Tukey’s post hoc test will be used. p value <0.05 will be considered statistically significant.


For microbiological analysis non parametric tests will be used. Kruskal-Wallis Analysis of Variance will be used for multiple group comparison followed by Mann Whitney test for group wise comparison. For Intra group comparison Wilcoxons-signed rank test will be used.
Duration of study: 1 year
7.3 Does the study require any investigation (or) intervention to be conducted on patients (or) other humans (or) animals? If so please describe briefly :

Yes.

Baseline examinations will be done by a single examiner and scores for modified plaque index and gingival index will be recorded. All the subjects will be provided with their assigned products and instructed to use once daily before brushing. All the subjects will be instructed to follow their routine oral hygiene practices along with the assigned products. At 15 days, 30 days and 45 days, assessment will be made by the same examiner using the same indices and salivary sampling will be done followed by analysis of microbial counts.




7.4 Has ethical clearance been obtained from your institution?

Yes







LIST OF REFERENCES :

  1. Hebbar A, Keluskar V, Shetti A. Oil pulling – Unravelling the path to mystic cure. J Int Oral Health.2010;2(4):12-4.

  2. Singh A, Purohit B. Tooth brushing, oil pulling and tissue regeneration: A review of holistic approaches to oral health. J Ayurveda Integr Med.2011;2(2):64-8.

  3. Ashokan S, Emmadi P, Chamundeshwari R. Effect of oil pulling on plaque induced gingivitis: A randomised controlled triple blinded study. Indian J Dent Res.2009;20(1):47-51.

  4. Thaweboon S, Nakaparksin J, Thaweboon B. Effect of oil pulling on oral microorganisms on oral biofilm models. Asia J Public Health.2011;2(2):62-6.

  5. HV Amith, Ankola A, L Nagesh. Effect of oil pulling on plaque and gingivitis. J Oral Health Comm Dent.2007;1(1):12-8.

  6. Ashokan S, Rathnan J, Muthu MS, Rathna Prabhu V, Emmadi P, Chamundeshwari R. Effect of oil pulling on Streptococcus mutans count in plaque and saliva using Dentocult SM Strips Mutans test:A randomized, controlled, triple blind study. J Indian Soc Pedod Prevent Dent. 2008;26(1):12-7.

  7. Turesky S, Gilmore ND, Glickman I. Reduced Plaque Formation by the Chloromethyl Analogue of Victamine C. J. Periodont.1970;41:41-3.

  8. Loe H, Silness J. Periodontal disease in pregnancy I. Prevalence and severity. Acta odontol scand.1963;21:533-51.




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