The Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion Incorporated Sodium Carboxymethyl Cellulose Gel With Periodontal Debridement in the Treatment of Periodontitis. Clinical- Biochemical Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Clinical attachment loss will be quantified in centimeters before and after treatment
研究概览
简要总结
Periodontitis is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth.
Hydroxylated poly methoxy flavones are a combination of naturally occurring flavonoids extracted from the orange peel and exert anti-inflammatory, antibacterial, and antifungal activity however, this extract is poorly soluble and poorly absorbable. In this work, this extract was formulated as a solid dispersion formulation to enhance its biological activity and then incorporated into a gel base and used in the treatment of periodontitis after clinical debridement.
详细描述
In the study, there are 3 groups; the first one first one received plain sodium carboxymethylcellulose. Group II received chlorhexidine gel. GroupIII received Hydroxylated poly methoxy flavones solid dispersion incorporated into sodium carboxymethylcellulose gel.
In all groups, there is clinical debridement before injection of gels.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with periodontitis stage I-II
- •free from any systemic disorders.
- •no mobility - non-smokers - no parafunctional habits.
- •Each patient with minimum three periodontitis sites ( split-mouth study)
排除标准
- •patients with diabetes, and hypertension.
研究组 & 干预措施
hydroxylated polymethyl flavones group
SRP then hydroxylated polymethyl flavones addition
干预措施: scaling and root planing (Procedure)
hydroxylated polymethyl flavones group
SRP then hydroxylated polymethyl flavones addition
干预措施: hydroxylated poly methoxy flavones (Drug)
Chlorohexidine group
SRP then Chlorohexidine gel application
干预措施: scaling and root planing (Procedure)
Chlorohexidine group
SRP then Chlorohexidine gel application
干预措施: chlorhexidine (Drug)
placebo group
SRP then placebo gel application
干预措施: scaling and root planing (Procedure)
placebo group
SRP then placebo gel application
干预措施: placebo (Drug)
结局指标
主要结局
Clinical attachment loss will be quantified in centimeters before and after treatment
时间窗: One week
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel than in other groups
Pocket Depth will be quantified in centimeters before and after treatment
时间窗: One week
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel
次要结局
未报告次要终点
研究者
Ahmed Mortada
Head of Department of Oral Medicine, Periodontology and Diagnosis
Assiut University