COMPARATIVE EVALUATION OF THE EFFICACY OF OMEGA-3 FATTY ACIDS ALONG WITH LOW DOSE ASPIRIN AND LOW LEVEL LASER THERAPY AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS - A CLINICO-BIOCHEMICAL STUDY
Brief Resume of the intended work
Need for the study:
Periodontal disease is a local chronic inflammation initiated by specific micro-organisms. Tissue destruction is characterized by inflammatory neutrophil mediated tissue injury followed by chronic infiltration of monocytes and the establishment of acquired immune lesion.1 Although periodontal diseases are associated with specific pathogenic bacteria, over the last two decades the studies on the pathogenesis of disease revealed that most tissue damage is caused by the host response to infection2, 3, 4
Various surgical and non-surgical methods have been tried in the treatment of periodontitis, in which host modulatory response has emerged as a new concept for the treatment. Host modulatory response aims to reduce tissue destruction, stabilize or even regenerate the periodontium by modifying or down-regulating destructive aspects of the host response and up-regulating the protective or regenerative response.5
Host modulatory therapy comprises systemically or locally delivered pharmaceuticals that is prescribed as a part of periodontal therapy and is used as adjuncts to conventional periodontal treatment.6 A variety of different drug classes have been evaluated as host modulation agent, including Non-steroidal anti-inflammatory drugs (NSAIDs), tetracyclines, and bisphosphonates.7
NSAIDs either systemically or topically administered have not had clinical applications, the magnitude of improvement is measurable but need for prolonged therapy with the concomitant risk of adverse side effects limits the use of NSAIDs.8 Sub-antimicrobial dose of doxycycline therapy that extended > 3 months showed beneficial results when combined with non-surgical therapy, how ever potential adverse effects were inherent.9 Bisphosphonates provides minor changes, but their long term use was recently questioned in relation to increase risk of osteonecrosis of the jaws after tooth extraction.10
Omega 3 polyunsaturated fatty acids including docosahexaenoic acid( DHA ; C22:6 n-3) and eicosapentaenoic acid ( EPA ; C20;5 n-3) were shown to have therapeutic value, anti-inflammatory and protective actions in rheumatoid arthritis, cystic fibrosis, ulcerative colitis, asthma, atherosclerosis, cancer, cardiovascular disease and periodontitis.11
The beneficial actions of omega 3 PUFAs were attributed at first to decrease in the production of classic inflammatory mediators such as arachidonic acid-derived eicosanoids (prostaglandin E2) and inflammatory cytokines.12 But seminal work by Charles serhan et al. and Hong et al. demonstrated that omega 3 PUFAs serve as substrates for enzymatic conversion to a novel series of lipid mediators that were named resolvins & protectins. This new class of bioactive lipid mediators modulates the protective and beneficial actions of omega 3 PUFAs.12, 13
Researchers have proposed the use of different wave lengths as an adjunct to scaling and root planing.14 The possibility of substituting conventional treatments for laser therapy is controversial.14, 15Combining laser treatment with conventional treatment is one of the most successful methods in clinical practice.
In medicine and dentistry, diode lasers have been used predominantly for applications which are broadly termed low level laser therapy (LLLT) or ‘biostimulation”. There have been many claims for the therapeutic effects of LLLT on a broad range of disorders. This includes: acceleration of wound healing, enhanced remodeling and repair of bone, restoration of normal neural function following injury, normalization of abnormal hormonal function, pain attenuation, stimulation of endorphin release, and modulation of the immune system20
The purpose of this study is to compare and evaluate the efficiency of omega – 3 fatty acids and low dose aspirin along with low level laser as an adjunct to scaling and root planing in treatment of periodontits.
Review of literature:
Studies by Van dyke TE in 2008 shown that Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA), the major components of Omega-3 PUFA were found to alter cellular functions of polymorphonuclear leukocytes, modulate lymphocyte proliferation, and enhance endogenous host antioxidant capacity.17
Studies by Synur Vardhar in 2004 shown that therapeutic usage of omega -3 fatty acids significantly reduced the gingival tissue levels of PGE2, PGF2α, LTB4, PAF, in experimental.18
Studies of Fernades J and Venkatraman G in 1993 have evaluated the beneficial effects of fish oil as a rich dietary source of omega-3 fatty acids on diverse physiological process in body and on a variety of chronic inflammatory disease including periodontal disease.19
Studies of SaynurVardhar and Sengul in 2008 shown that selective cyclogenase-2 inhibitor, omega-3 fatty acids and a combination of these two can inhibit gingival tissue MMP-8 tissue expression, which plays an important role in tissue destructive mechanisms associated with periodontitis.20
Studies of Serhan CN, Hong S in 2002 shown that metabolism of omega-3 fatty acids taken concurrently with aspirin yields products (resolvins and protectins) which are more potent and stable than those endogenously produced13
Objective of the study:
To evaluate the clinical and biochemical outcome of scaling and root planing in treatment of chronic periodontitis
To evaluate the efficacy of Omega 3 fatty acids and low dose aspirin as an adjunct to scaling and root planing
To evaluate the efficacy of Omega 3 fatty acids and low dose aspirin along with low level laser therapy as an adjunct to scaling and root planing
To compare the treatment outcomes of scaling and root planing with or with out Omega-3 fatty acid and low dose aspirin along with low level lasers on the treatment of chronic periodontits
Materials And Methods:
Source of data
Thirty nine patients reporting to the Department of Periodontics, Coorg institute of Dental Sciences, Virajpet with periodontal pocket depth ≥ 5mm will be treated and followed up for three months
Method of collection of data
Patients will be informed and written consent will be taken from the patients.
Patients will be randomly allotted to three groups.
Group B: 13 patients, where scaling and root planing will be followed up by systemic administration of Omega-3 fatty acid and low dose aspirin
Group C: 13 patients, where scaling and root planing will be followed up by systemic administration of Omega-3 fatty acids and low dose aspirin along with low level laser treatment.
Patients diagnosed with chronic periodontitis and good systemic health
Untreated chronic periodontitis
30- 55 years of age
4) Teeth with pocket depth ≥ 5mm
Systemic illness (diabetes mellitus, cancer, human immune deficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
Pregnancy or lactation
Systemic antibiotics with in previous 2 months
Chronic use of NSAIDs
Confirmed or suspected intolerance to aspirin
Periodontal therapy with in previous year
Clinical parameters to be used are:
Plaque index (PI) (Silness & Loe 1967)
Modified gingival index (Lobene et al 1986)
Bleeding on probing ( evaluated 30 seconds following pocket probing, a score of 0 (no bleeding) and score 1 (bleeding) will be given)
Clinical attachment level (standardized using an acrylic stent and measured by using a UNC-15 probe from a fixed reference point to the base of the pocket).
Probing pocket depth ( standardized using acrylic stent and measured by using UNC-15 probe taken from the margin of gingival to base of pocket)
G.C.F sampling: Samples will be collected at base line and 3 months after treatment.GCF samples will be taken in morning, 5µl of GCF will be collected in a micro-pipette. GCF samples will be centrifuged to remove debris and immediately frozen and will be stored at -200 C. Levels of MMP-9 an important mediator of inflammation of tissue destruction will be determined in GCF using enzyme linked immunosorbent assay (ELISA)
Does the study require any investigations or interventions to be conducted on the patients or other humans or animals? ( If so please describe briefly)
YES, scaling and root planing and the systemic admistration of omega 3 fatty acid and low dose aspirin, application of laser will be done after taking a written consent from patient.
Has Ethical clearance been obtained from your institution in case of 7.3?
List Of References
Lamster IB, Smith QT, Celenti RS, Singer Re, Grbic JT. Development of a risk profile for periodontal disease: Microbial and host response factors. J Periodontology 1994; 65(suppl. 5):511-520
Page RC. The role of inflammatory mediators in the pathogenesis of periodontal disease. J Periodontal Res 1991; 26:230-242.
Reddy MS, Geurs NC, Gunsolley JC. Periodontal host modulation with antiproteinase, anti-inflamatory, and bone sparing agents. A systematic review. Ann Periodontol 2003; 8:12-37
Van Dyke TE, Serhan CN Resolution of inflammation: A new paradigm ffor the pathogenesis of periodontal disease. J Dent Res 2003; 82:82-90
Bhavadekar NB, Willams RC. New directions in host modulation for the management of periodontal disease J Clinical Periodontology 2009; 36:124-126.
Salvi GE, Lang NP. Host response modulation in the management of periodontal disease. J Clinical Periodontology 2005; 32(suppl. 6):108-129.
Novak MJ, Johns LP, Miller RC, Bradshaw MH. Adjunctive benefits of subantimicrobial dose doxycycline in the management of severe,generalized, chronic periodontits. J Periodontology 2002;73:762-769
Solvegia. Er, Cr: YSGG Laser versus scaling and root planing. Lasers in medical science 2010; 1:46.
13. Serhan CN, Hong S, Gronert K, et al. Resolvings: A family of bioactive products of omega-3 fatty acid transformation circuts initiated by aspirin treatment that counter proinflamation signals. J Exp Med 2002; 196:1025-1037.
14. Schwarz, F., Sculean, A., Georg, T., et al. (2001). Periodontal treatment with an Er: YAG láser compared to scaling and root planing. A controlled clinical study. J. Periodontology 2001: 72:361-367.
15. Yilmaz, S., Kuru, B., Kuru, L., et al. (2002). Effect of galium arsenide diode láser on human periodontal disease: a microbiological and clínical study. Lasers Surgery Medicine. 30, 60-66.
16. Van Dyke TE. The management of inflammation in periodontal disease. J Periodontology 2008;79:1601-1608.
17. Saynur Vardar, Eralp Budeneli, Oya Turko lu, Haluk Baylas: Therapeutic versus prophylactic plus therapeutic administration of omega-3 fatty acid on endotoxin-induced periodontitis in rats. J Periodontology 2004; 75:1640-1646.
18. Fernandes G, Venkatraman J. Role of omega-3 fatty acids in health and disease. Nutr Res 1993; 13:s19-s45.
19. Saynur Vardhar-Sengul, Eralp Budneli, Oya Turkoglu, Timo Sorsa,: The effects of selective cox-2 inhibitor/celecoxib and omega-3 fatty acids on matrix metalloproteinases, TIMP-1, and Laminin-5γ2-chain immunolocalization in experimental periodontits. J Periodontology 2008;79:10:1934-1941
20. L.J Walsh: The current status of low level laser therapy in dentistry. Part 1. Soft tissue applications. Australian Dental Journal 1997;42:(4):247-54
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Remarks of the Guide
Name & Designation of (In block letters) 11.1 Guide