The Effect Of SRP With Adjunctive Systemic Therapy Of Leukotriene Receptor Antagonist-Montelukast On The Serum C Reactive Protein Levels & Clinical Parameters In Chronic Periodontitis Patients - A Randomized Controlled 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 the serum C- reactive protein levels at 3 weeks and 6 weeks
研究概览
简要总结
The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and root planing in patients with chronic periodontitis leads to host inflammatory response modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open new vistas in treatment of chronic periodontitis.
详细描述
A RCT was carried out to check the efficacy of Montelukast as an adjunct to scaling and root planing. The patients were randomised to either test group (SRP + Montelukast) and control group (SRP). Clinical parameters were assessed at baseline, 3 weeks and 6 weeks. Serum C-reactive protein levels were assessed at baseline, 3 weeks and 6 weeks.
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 of 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 (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013,
- •Confirmed or suspected intolerance to Montelukast,
- •Periodontal therapy done within the January 2012 to Jun 2013.
研究组 & 干预措施
Montelukast
Patients in Test Group were given Leukotriene receptor antagonist, Montelukast 1 tablet twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.
干预措施: Montelukast (Drug)
Placebo
Patients in Control Group were given placebo drug 1 tablet twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks
时间窗: baseline, 3 weeks and 6 weeks
The biochemical parameter of serum C- reactive protein levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) the change in C- reactive protein levels was analysed.
Changes from baseline in the probing pocket depth at 3 weeks and 6 weeks
时间窗: baseline, 3 weeks and 6 weeks.
The probing pocket depths were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in probing pocket depth was analysed.
Changes from baseline in the clinical attachment level at 3 weeks and 6 weeks.
时间窗: baseline, 3 weeks and 6 weeks
The clinical attachment levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in clinical attachment levels was analysed.
次要结局
- Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks(baseline, 3 weeks and 6 weeks)
- Changes from baseline in Plaque Index (PI) at 3 weeks and 6 weeks(baseline, 3 weeks and 6 weeks)
- Changes from baseline in Oral Hygiene Index-Simplified (OHI-S) at 3 weeks and 6 weeks(baseline, 3 weeks and 6 weeks)
- Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks(baseline, 3 weeks and 6 weeks)
研究者
Dr.Saurabh Inamdar
Principal Investigator
Tatyasaheb Kore Dental College