The Effect of Systemic Administration of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients With Stage II and III Periodontitis After Non-surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 主要终点
- change from baseline Hb-A1c
研究概览
简要总结
To evaluate the effect of systemic administration of zinc on the gingival crevicular fluid level of total oxidant capacity in controlled Type-2 diabetic patients with stage-II and III periodontitis after non-surgical periodontal therapy.
详细描述
Hypozincaemia and hyperzincuria is known to be present in patients with type-2 diabetes, and Zinc supplementation is known to be helpful in restoring plasma Zinc levels to normal,Zinc's deficiency can lead to an increase in circulating glucose due to beta cells malfunctioning and resistance to insulin, which makes it easier for type 2 diabetes mellitus (DM2) to happen ,Zinc was found to be a structural part of key anti-oxidant enzymes such as superoxide dismutase (SOD), and Zinc deficiency impaired their synthesis, leading to increased oxidative stress
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor and statistician will be blinded to the intervention
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Controlled Type-2 diabetes mellitus
- •Stage-II &III periodontitis
- •At least 2 sites with clinical attachment loss 3 or 4 mm to ≥5 mm and radiographic bone loss 15% Extending to mid-third of root and beyond.
- •Probing depth from ≤5 mm to ≥6 mm
排除标准
- •Any periodontal or Antibiotic treatment during the last six months.
- •Receiving trace element supplements in the previous three months
- •Pregnant or lactating females
- •Gastric or diuretic treatment
- •Acute renal failure
研究组 & 干预措施
Zinc administration with scaling and root planing
systemic administration of Zinc cap of 50 mg elemental zinc as zinc sulphate, once a day for 12 weeks in addition to scaling and root planing
干预措施: Zinc Sulfate (Drug)
scaling and root planing
scaling and root planing
干预措施: scaling and root planing (Procedure)
结局指标
主要结局
change from baseline Hb-A1c
时间窗: change from baseline Hb-A1c at 3 monthes
次要结局
- Clinical attachment level(at the baseline and after 3 months)
- Probing pocket depth(at the baseline and after 3 months)
- Hb-A1c(at the baseline and after 3 months)
- Gingival index(at the baseline and after 3 months)
研究者
Abdulrahman Abdulqawi Awadh Abdulrab
Principal Investigator
Cairo University