Effect Of Omega 3 Fatty Acid and Low Dose Aspirin as An Adjunct to Periodontal Therapy in Chronic Periodontitis Patients with Type II Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CRP levels, lipid profile, and HbA1C
研究概览
简要总结
Omega-3 polyunsaturated fatty acids (ω-3 PUFA), including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), have been investigated for their therapeutic actions in rheumatoid arthritis, ulcerative colitis, atherosclerosis, cardiovascular diseases, cancer, psoriasis and periodontitis. Beneficial results were observed and attributed to the actions of specialized proresolving mediators (SPMs) biosynthesized from ω-3 PUFA (resolvins, protectins and maresins) and upregulation of endogenous SPMs (lipoxins). Studies also showed that low dose aspirin (LDA) triggers the synthesis of more potent SPMs, called aspirin-triggered resolvins, aspirin-triggered protectins, and aspirin-triggered lipoxins that have a longer half-life in blood. SPMs promote the resolution of inflammation by reducing neutrophil infiltration, regulating cytokine/chemokine synthesis, attenuating systemic C-reactive protein (CRP) and interleukin (IL)-1 production, decreasing the production of RANKL19, and regulating macrophage-secreted pro-inflammatory cytokines. Previous studies has highlighted the advantages of adjunctive oral administration of ω-3 PUFA with LDA in periodontal wound healing and inflammatory markers.
Very few studies have hypothesized that the combined treatment protocol would lead to improved periodontal and immunological outcomes when compared to periodontal debridement alone. No other study was carried out with similar observation in type -II diabetes patients till now. So, the aim of this study was to investigate periodontal and immunological effects of daily supplementation of ω-3 PUFA and 75mg LDA for 3 months as an adjunctive therapy to periodontal treatment in chronic periodontitis patients with type 2 diabetes.
Total of 40 chronic periodontitis patients with type II diabetes will be recruited from the outpatient department of periodontology, Sibar institute of dental sciences, Guntur, Andhra Pradesh, India.
Randomization will be carried out to divide the patients into 2 groups
Group A (n=20)- oral supplementation of omega 3 fatty acid and low dose aspirin as an adjunct to periodontal therapy.
Group B (n=20) oral supplementation of placebo in chronic periodontitis patients with type II diabetes.
1. Periodontal parameters (BOP,PPD,CAL) were recorded, and blood sample will be collected for measuring CRP levels, lipid profile, and HbA1C at baseline.
2. Scaling and root planning will be carried out for all the patients in both the groups
3. Oral hygiene instructions will be given.
4. Omega 3 fatty acid (100mg) and aspirin (75mg) or placebo will be given to Group A and placebo for Group B for 3months
All the parameters will be recorded at baseline and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with age group of 30-60 years of either gender.
- •Stage II periodontitis with at least 6 sites with PD and CAL between 5 to 7 mm Diagnosis of type 2 diabetes for ≥5 years Patients under treatment for diabetes with oral hypoglycemic agents and/or insulin, with glycated hemoglobin (HbA1c) levels ≥6.5% to ≤11% Patient who are willing to give informed consent.
排除标准
- •Smokers, Scaling and root planing in the previous 6 months, Antimicrobial therapy in the previous 6 months; systemic conditions (other than diabetes) that could affect the progression of periodontitis Long-term use of medication that could interfere with periodontal response Pregnant and lactating women.
- •History of peptic ulcer Allergy to fish/seafood or Low dose aspirin.
结局指标
主要结局
CRP levels, lipid profile, and HbA1C
时间窗: baseline and 3 months
次要结局
- Bleeding on probing, probing pocket depth and clinical attachment level(baseline and 3 months)
研究者
Dr Katuri Kishore Kumar
sibar institute of dental sciences