Clinical Evaluation of 1% Curcumin Oral Gel and Its Effect on the Clinical Attachment Level and the Level of IL-8 in GCF in Treatment of Periodontal Pocket
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- measuring plaque accumulation
研究概览
简要总结
application of 1% curcumin gel in clinical study design will be used . The study will be conducted in Al-Najaf specialised dentistry center. The group of patients will be consist of 25 patients, belonging to both sex, age between 30-45 years. All patients will be diagnosed as chronic periodontitis with periodontal pockets of depth 5-7mm bilaterally to be randomly selected.
详细描述
Abstract:
Background: Complete removal of irritants is not possible with mechanical therapy alone. Adjunctive use of systemic administration of antibiotics results in the distribution of drug throughout the body, which can give rise to toxicity. Curcumin (diferuloylmethane), a constituent of Curcuma longa plant, which possess antioxidant, anti-inflammatory, and anti-microbial properties. The aim of the study is to determine the effect of curcumin oral gel on the anti-inflammatory chemokines (IL_8) in the gingival crevicular fluid and to compare the effects of the curcumin gel as an adjunct to sub gingival scaling and root planing with the effect achieved using sub gingival scaling and root planing alone.
Twenty systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed and the patients will receive a complete prophylaxis including scaling and root planning. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planning alone will be performed followed by periodontal pack application. collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
The aim of the study :
To determine the effect of curcumin oral gel on the anti inflammatory chemokines (IL_8) in the gingival crevicular fluid and to compare the effects of the curcumin gel as an adjunct to sub gingival scaling and root planning with the effect achieved using sub gingival scaling and root planing alone in the treatment of (5-7 mm) periodontal pockets on clinical Parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
盲法说明
care provider not involved in the study
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age group of 30-45 years.
- •Belonging to both sexes.
- •Chronic periodontitis patients.
- •Probing pocket depth (PPD) 5-7 mm.
排除标准
- •Subjects having taken antibiotics prior to or during the trial.
- •Patients on medication likely to induce gingival enlargement.
- •Pregnant or lactating women.
- •Tobacco chewers.
- •Allergy to curcumin oral gel.
- •Patients with systemic disease.
研究组 & 干预措施
curcumin oral gel
干预措施: curcumin Oral gel (Drug)
curcumin oral gel
干预措施: subgingival scaling and root planing (Procedure)
subgingival scaling and root planing
干预措施: subgingival scaling and root planing (Procedure)
结局指标
主要结局
measuring plaque accumulation
时间窗: one month
measuring plaque accumulation on the teeth by measuring the plaque index using periodontal probe
measuring the periodontal pocket depth
时间窗: one month
measuring the periodontal pocket depth by using periodontal pocket depth index using periodontal probe
measuring interleukin -8
时间窗: one month
measuring interleukin -8 in gingival crevicular fluid by using ELISA
measuring periodontal pocket erosion
时间窗: one month
measuring periodontal pocket erosion and destruction by measuring bleeding on probing index using periodontal probe
measuring gingival inflammation
时间窗: one month
measuring gingival inflammation by measuring the gingival index by using periodontal probe
measuring periodontal attachment level
时间窗: one month
measuring periodontal attachment level by measuring clinical attachment level index using periodontal probe
次要结局
未报告次要终点
研究者
Haider Thabit
Specialist dentist
University of Baghdad