Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum level of chemerin
研究概览
简要总结
Patient grouping
- Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
- Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL).
6.Omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.
详细描述
A parallel design randomized clinical trial was performed involving thirty participants divided into two groups, 15 participants in each group selected from the outpatient clinic in Oral medicine and Periodontology department.
Diabetic control was assessed by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 m. HbA1c was assessed at baseline, 3m, and 6m.
Patient grouping
- Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
- Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) Periodontal treatment protocol
Group 1 and 2 patients were treated by non-surgical approach in following steps:
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)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had type 2 DM for more than 2 years (diagnosed according to the American Diabetes Association criteria), with no other systemic problem. •Subjects had 14 or more natural teeth, of which at least five had a site with probing pocket depth (PPD) ≥ 5 mm and clinical attachment level ≥ 3 mm. From this point, according to the American Academy of Periodontology, subjects with moderate to severe periodontitis were included
排除标准
- •Pregnant and breastfeeding women, smokers or former smokers, patients with other autoimmune or systemic disease, those patients who took antibiotics in the last 6 months and patients weren't willing to follow our study protocol or plaque regimen
研究组 & 干预措施
group I
Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3
干预措施: Omega 3 (Drug)
group I
Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3
干预措施: SRP alone (Procedure)
group II
Type 2 Diabetes Mellitus patients with CPD + SRP
干预措施: SRP alone (Procedure)
结局指标
主要结局
Serum level of chemerin
时间窗: 6 months
Serum level of chemerin
次要结局
- hba1c(6 months)
- periodontal clinical parameters(6 months)
- GCF level of chemerin(6 months)
研究者
Ayman El-Gawish
lecturer
British University In Egypt