Effect of Scaling & Root Planing (SRP) Combined With Therapy Of Omega-3 Fatty Acid on Clinical Parameters and Serum Levels of C-Reactive Protein (CRP) in Chronic Periodontitis - A Randomised Control Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes from baseline in pocket depth (PD) at 6 weeks and 12 weeks
研究概览
简要总结
Omega 3 fatty acids is one such dietary supplement, known to modulate the host response in chronic conditions like cardiovascular diseases, rheumatoid arthritis, ischemic cerebrovascular diseases, osteoporosis by producing Resolvins and protectins without showing any inadvertent effects.Addition of systemic Omega 3 Fatty Acids with SRP may enhance the therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory properties. If proven, this can be used as a routine treatment modality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients within age group of 30 to 55 years.
- •Systemically healthy individuals.
- •Patients with chronic generalized periodontitis (moderate and severe)according to Center for Disease Control (CDC) working group, 2007 criteria.
排除标准
- •Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy),
- •Chronic alcoholics,
- •Pregnancy or lactation,
- •Use of Non Steroidal Anti Inflammatory Drugs, steroids or antibiotics / antimicrobials within September 2012 to August 2013,
- •Confirmed or suspected intolerance to omega 3 fatty acids,
- •Periodontal therapy done within the September 2012 to August 2013.
研究组 & 干预措施
Test Group
Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks
干预措施: Omega 3 fatty acid (Drug)
Control Group
Patients with Chronic Periodontitis in Control Group were prescribed Placebo tablets once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in pocket depth (PD) at 6 weeks and 12 weeks
时间窗: baseline, 6 weeks and 12 weeks
changes from baseline in clinical parameter, PD were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. PD was measured in millimeter.
Changes from baseline in Clinical Attachment Level (CAL) at 6 weeks and 12 weeks.
时间窗: baseline, 6 weeks and 12 weeks
changes from baseline in clinical parameter, CAL were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. CAL was measured in millimeter.
Change from baseline in serum CRP level at 6 weeks and 12 weeks
时间窗: baseline, 6 weeks, 12 weeks
changes from baseline in biochemical parameter, serum CRP levels were assessed at 6 weeks and 12 weeks after starting therapy with omega 3 fatty acids. Serum CRP level was measured in milligram/liter (mg/l)
次要结局
- Changes from baseline in Gingival Index (GI) at 6 weeks and 12 weeks(baseline, 6 weeks and 12 weeks)
- Changes from baseline in Sulcus Bleeding Index (SBI) at 6 weeks and 12 weeks(baseline, 6 weeks and 12 weeks)
- Changes from baseline in Plaque Index (PI) at 6 weeks and 12 weeks(baseline, 6 weeks and 12 weeks)
- Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 6 weeks and 12 weeks.(baseline, 6 weeks and 12 weeks)
研究者
GIRISH DEORE
Principal Investigator
Tatyasaheb Kore Dental College