Glucosamine Sulphate as an Adjunctive Therapy to Closed Mechanical Debridement Reduced Gingival Cervicular Fluid IL-1β in Patients With Chronic Periodontitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- gingival crevicular fluid IL-1β level
研究概览
简要总结
This study is the first evidence based work evaluated the systemic use of glucosamine as an adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of patients with moderate to advanced chronic periodontitis
详细描述
Targeting the inflammatory response may be a rational approach to the medical treatment of chronic periodontitis. Glucosamine sulphate (GS) was proven to have anti-inflammatory actions with minimal side effect profile. Objectives; The main objectives of this study were to evaluate clinically the efficacy of GS; as a novel adjunctive host modulating agent in periodontal therapy and to investigate its effect on gingival crevicular fluid (GCF) level of IL-1β. Methods; Forty patients with moderate to severe chronic periodontitis (CP) were included in this study. They were randomly divided into two groups. Group I (G1) patients (n=20) received 500 mg GS capsules three times daily for 3 months following full mouth scaling and root planing (SRP), while group II (G2) patients (n=20) received a placebo for the same period following full mouth SRP. Clinical periodontal parameters and GCF IL-1β levels were analyzed at baseline and 3 months following therapy.
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 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good compliance with the plaque control instructions following initial therapy
- •each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm
- •teeth involved were all vital with score 0-1 mobility
- •availability for the follow-up and maintenance program;
排除标准
- •no systemic diseases which could influence the outcome of therapy as evidenced by Burket's Oral Medicine health history questionnaire
- •absence of periodontal treatment for the previous year
- •absence of systemic medication or antibiotic treatment for the previous six months
- •absence of a smoking habit.
- •post menopausal, pregnant or breast feeding women were excluded from participating in the study. Patients with contraindications to glucosamine sulphate therapy e.g., hypersensitivity to any of the product's components or with inadequate compliance with the oral hygiene maintenance schedule were also excluded from the study.
研究组 & 干预措施
glucosamine sulphate capsules
500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.
干预措施: glucosamine sulphate (Drug)
lactose capsules
lactose capsules three times daily for 3 months
干预措施: lactose capsules (Drug)
结局指标
主要结局
gingival crevicular fluid IL-1β level
时间窗: 0-3 months
baseline and after three months of Glucosamine Sulphate administration
次要结局
- probing depth(0-3 months)
- clinical attachment level(0-3 months)
- gingival index(0-3 months)
- plaque index(0-3 months)
研究者
Mai Shafik Attia
lecturer of oral medicine and periodontology
Ain Shams University