Using Pure Sesame Oil as Supportive Treatment for Oral Ulcers - Case Study Example

Using Pure Sesame Oil as Supportive Treatment for Oral Ulcers: Steven Johnson Syndrome& Chemotherapy 0 Study Objectives 1 Primary Objective The goal of this study will be to investigate the efficacy and safety of sesame oil on oral ulcers (Steven Johnson Syndrome& chemotherapy).We apply this study on two groups one of them will be treatment group and other will be controlled group to test the efficacy and safety of using pure sesame oil as saliva substitute and mouthwash in chemotherapy or Steven Jonson Syndrome who has oral ulcers. The study will take three months twice a month. The examination will be orally to evaluate changing ulcer rate. 1.2 Secondary Objective The secondary objective this study will to establish the validity and the reliability of the oil pulling to treat the oral ulcers benchmarked against the period taken for oral ulcers to heal for both controlled and uncontrolled cohorts. 2.0 Background and Rationale 2.1 Background: condition, Disease Sesame Oil has been effectively used in India for a thousand years as mouthwash as well as antifungal. The oil pulling has also been introduced in United States in the early 1990s by a medical doctor called Karach who successfully employed the intervention in his medical practice. Oral pulling is thus known as a remedy for oral health and detoxification as it acts as agents that pull harmful bacteria, fungus as well as other harmful organisms out of the mouth, gums, teeth and throat thus minimizing possibility of oral ulcers. The pure Sesame Oil is put and swished around the mouth for about 20 minutes and spitting out the content. The oil blends well with the saliva and turned into a thin white liquid with the lipids in the oil pulling out the toxins from the saliva. Oral ulcers are symptoms of chemotherapy and Steven Johnson Syndrome patient. They may develop form ulcer to toxic epidermal necrolysis. That because decrease in immunity and moist. Sesame oil will work as bacterial and fungal inhabitant, saliva substitute, and promote ulcer healing because it include Vitamin E. Stevens-Johnson syndrome is an acute, severe adverse cutaneous reaction to medication that was noted in 1992 in two children with febrile erosive stomatitis, disseminated cutaneous eruption of discrete dark red maculae and severe ocular involvement. Most of cases of this syndrome were linked to particular medication. The mechanism behind Steven-Johnson Syndrome are unknown with authors suggesting that the cutaneous changes attached to chemotherapy resulting from direct toxic effects. Such standardized premedication regimen like application of high-dose dexamethasone, diphenhydramine and cimetidine (a type 1 histamine (H1)-antagonist) failed to prevent severity of skin toxic. The prophylactic regimen intervention may hence be insufficient in some situation. The risk presented due to academic research gap to justify relationship between Steven-Johnson Syndrome and paclitaxel calls for the need to recognize the characteristics of adverse effect with respect to patients given paclitaxel. Some reports attach Steven-Johnson Syndrome as being induced by other antiulcer agents such as etoposide, methotrexate, rituzimab and imatinib but no supportive evidence-based reports that paclitaxel induce Steven-Johnson Syndrome hence calls for vigilance amongst the clinicians. On the other hand, over the last decades, a range of new chemotherapeutic agents have been employed in the treatment of ulcer. The set of drugs are categorized based on the mechanism action such as signal transduction inhibitors (Epidermal growth factor receptor-EGFR-antagonists and Multikinase inhibitors). Chemotherapeutic agents have been employed in the application of Chemotherapy in the treatment of ulcer especially, tumors have been beneficial but at the same attached to adverse side effects. With respect to new chemotherapic agents and protocols in oncology, survival rates have increased in patients affected by ulcer but the increased application of has been accompanied by an expansion in the rise of incidence of cutaneous side effects hence worsening of quality of life amongst the patients. For appropriateness in the administration of these interventions, proper management of skin toxicity with respect to chemotherapic agents is inevitable to ensure enhanced clinical outcomes and life quality is uncompromised 2.2 Study Rationale Based on the review of the literature on the earlier studies with respect to the study conducted by the Department of Pathobiology, Graduate School of Nursing, Chiba University, Chiba, Japan (toshiko.og@chiba-u.jp), on the effect of edible Sesame Oil on Growth of Clinical Isolates of Candida albicans. The result of this study justified the ability of Sesame Oil to inhibit the growth of the mycelia form hence showing a higher correlation with sesame oil concentration. From this revelation, it is rational to employ the sesame oil as anti-fungal in the treatment of oral ulcer particularly as a mouthwash. Another study reviewed employed the use of Sesame oil on skin. The study noted the potentiality of Ozonized Sesame Oil to augment wound healing in rats (Stevens and Johnson, 1992). Ozonized oil treated wounds had significantly higher tensile strength, collagen content and superoxide dismutase activity than that of the vehicle treated wounds. Histopathological analysis of skin of the excised wound area treated with ozonated oil revealed better healing activity Vis-a-Vis vehicle-treated wounds. Thus, it can be concluded that ozonated oil can be of potential therapeutic use for healing wounds. Sesame oil is rich in antioxidants sesamol, sesamolin and sesamin as well as Vitamin E. The antioxidants inhibits absorption of negative forms of cholesterol in the liver with studies showing higher capacities of antibacterial of sesame oil hence used in prevention of gingivitis and dental cavities. 2. 3Inclusion Criteria The inclusion criterion will focus on those patients that who have ulcers resulting from the chemotherapeutic agent’s side effect in oral cavity. Another inclusion consideration will be with respect to those who have shown the symptom of Steven-Johnson Syndrome. Both male and female will be excluded based on the mentioned criterion. These patients will be of average age of 18 to 45 years. The participants ton be included will also showcase a feature top care about the oral hygiene and can follow strictly the prescription and or the administration instructions. 2.4 Exclusion Criteria The exclusion criterion will be based on those who do not have predisposing factors such as diseases which affect in oral cavity like AIDS. In addition, those who care less about oral hygiene will also be uncovered by the study. Those who abuse substance such Tobacco (smokers) will also be left out in this study. Another lot that will be excluded by the study will comprise those who do not have ulcer in oral cavity. 3.0 Statistical Consideration 3.1 Study Design The Experimental study will be based on an experiment trial1particularly the parallel group design and double bland to expose the efficiency on oral ulcer healing. This will help us closely follow on both the treated and untreated groups on the effects of the pure oil as a mouthwash in supporting the treatment of oral ulcers. 3.2 Statistical Hypothesis 3.2.1 Primary hypotheses Rate of promoting the Ulcer healing in chemotherapy and Steven-Johnson Syndrome patient. The outcomes will be based on the effectiveness of the Sesame pure oil as a supportive measure for the treatment of oral ulcer. 3.2.2 Secondary hypotheses Rat of action Sesame oil as reduce pain and fungal inhabitation. The outcomes will be based on the ability of the Sesame to reduce the pain and fungal inhabitation within the cavity hence showcasing on its validity and reliability to support the treatment of oral ulcer. 3.3 Sample Size and Randomization The will be conducted amongst 90 participants who are under chemotherapy treatment and have oral ulcer. The sample size will entail equal number of males and females. They will be selected according inclusion and exclusion based on a randomized selections. The study will be for three weeks after they took chemotherapy course immediately. The subject will be randomly allocated to two groups (treatment and control). The randomization will be effective in selecting the participants based on minimal cases of biasness for both excluded and included in the study besides. Besides it will be beneficial in determining those that will in the control and uncontrolled groups. The measure will be the size of ulcers by mm, pain, function. The study will make parameter for pain 0 to 3 with 0= no pain; 1=mild; 2=moderate; 3= sever. For function 0-3 (0= normal eating and drinking; 1=with pain; 2= cannot eat; 3=cannot eat or drink). And will take a swap sample to test fungal inhibition. 3.3 Treatment Assignment Procedure The group will pour oil sesame as oral rinse 5 ml four time a day, three times after each meal and the fourth time before sleeping. They should rinse 2 mints and should not eat or drink for two hours. On the other hand, the control group will use placebo (stander oral rinse). The patient will be examined clinically three times a week. 3.4 Plans for Maintaining Trial Randomization Codes In this study, Trial Randomization Codes will be maintained through blinding where the research hides what the scores got by particular treated and untreated groups. In this context the study will employ the double blind control of participants. The blinding is different from the allocation concealment. The researcher will therefore keep the trail participants unaware of the assigned intervention (use of Sesame Oil). This will weed out the possibility of biasness. Blinding will also help reduce the assessment differential outcome (information bias) hence enhancing the compliance and retention of trial participants and at the same time reducing biased supplemental care. Blinding of both control and treated participants will benefits the researcher in that participants will be less likely to leave trail before providing outcome data that could lead to loss of follow up. The blinded participants will also unlikely to seek additional adjunct interventions and also likely to compliance with the regimens. Bibliography Asokan S, Rathan J, Muthu M S, Rathna Prabhu V, Emmadi P, Raghuraman, Chamundeswari. Effect of oil pulling on Streptococcus mutans count in plaque and saliva using Dentocult SM Strip mutans test: A randomized, controlled, triple-blind study. Journal of Indian Society of Pedodontics and Preventive Dentistry. 2008. vol 26 issue 1, [[/12-17. Lowndes S, Darby A, Mead G and Lister A: Stevens-Johnson syndrome after treatment with rituximab. Ann Oncol 13:1948-50, 2002. Stevens AM and Johnson FC: A new eruptive fever associated with stomatitis and ophthalmia: report of two cases in children. Am J Dis Child 24: 526-533, 1922 Susser WS,Whitaker-Worth, Grant-Kels JM. Mucocutaneous reactions to Chemotherapy. J Am Acad Dermatol 1999. T. Durai Anand, C. Pothiraj, R. M. Gopinath, B. Kayalvizhi. Effect of oil-pulling on dental caries causing bacteria (PDF). African Journal of Microbiology Research. 2008 March. vol.(2) pp.063-066, Read More