Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Serum MDA
研究概览
简要总结
This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus.
详细描述
This study is a randomized double blinded clinical trial which was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus. The primary outcome measures were Serum MDA, CRP and Hb1AC. The secondary outcomes were modified gingival index(GI), Probing pocket depth(PPD), and Clinical attachment level(CAL). All the outcomes were measured at baseline, 2 months and 6 months.
The results were that the Lycopene with scaling and root planing group gave:
Statistically significant results in reducing Mean serum MDA levels at 2 months and 6 months respectively.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Patients on oral hypoglycemic drugs with no modification in therapy from the past 12 months
- •Chronic periodontitis as per AAP (American Academy of Periodontology) guidelines
- •Minimum of 15 natural teeth
- •At least four teeth with one or more sites with probing depth (PD) greater than or equal to 5 mm, clinical attachment level (CAL) greater than or equal to 4mm and bleeding on probing (BOP).
排除标准
- •History of antibiotic therapy within the previous 6 months
- •History of anti-inflammatory drugs within the previous 3 months
- •Pregnancy and lactation
- •Use of contraceptives or any other form of hormone
- •Usage of tobacco and tobacco related products
- •Periodontal treatment within 12 months.
研究组 & 干预措施
Lycored soft gels , Scaling and Rootplaning.
Systemic Lycored soft gels,(Jagsonpal Pharma) was given orally 8mgms/day for 2 months and Scaling and rootplaning (otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline
干预措施: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day (Drug)
Lycored soft gels , Scaling and Rootplaning.
Systemic Lycored soft gels,(Jagsonpal Pharma) was given orally 8mgms/day for 2 months and Scaling and rootplaning (otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline
干预措施: Scaling and root planing (Device)
Scaling and Rootplaning only.
Scaling and rootplaning(otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline.
干预措施: Scaling and root planing (Device)
结局指标
主要结局
Change in Serum MDA
时间窗: 6 Months Post treatment.
This unique outcome measure was assessed from baseline to 6 months post treatment by spectrophotometric estimation of serum Thiobarbituric acid substances (TBARS). The TBARS Assay measures malondialdehyde (MDA), a reactive compound formed from lipid peroxides that are generated under conditions of oxidative stress. Oxidative modification of lipids occurs with aging and various diseases, and increased oxidative stress is associated with diabetes and its complications. MDA forms an adduct with thiobarbituric acid (TBA). Results are calculated from a standard curve constructed with authentic MDA.
次要结局
- Change in Modified Gingival Index(6 Months post treatment.)
- Change in Probing pocket depth (PPD)(6 Months post treatment.)
- Change in Clinical attachment level (CAL)(6 Months post treatment.)
研究者
Manasa Ambati
Dr.Manasa Ambati
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre