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临床试验/CTRI/2024/05/067603
CTRI/2024/05/067603尚未招募2 期

Comparative evaluation of clinical efficacy and total antioxidant capacity of curcumin nanoparticle gel and green tea extract gel as an adjunct to scaling & root planing and scaling and root planing alone in treatment of stage 2 periodontitis patients A split mouth study

Dr Dikson Kuriakose1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年6月5日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
17
试验地点
1
主要终点
To evaluate efficacy of curcumin nanoparticle gel and green tea extract as an adjunct to scaling and root planing on clinical parameters and total antioxidant capacity in GCF of patient with Stage 2 periodontitis.

研究概览

简要总结

This study is designed to be a split mouth study where 17 patients of both the gender with Stage 2 periodontitis, satisfying all the inclusion criteria will be enrolled for the study. The total sample size calculated is 51 sites, further randomly divided into 3 groups of 17 sites per group and is treated by scaling and root planing, scaling and root planing with green tea extract gel and scaling and root planing with curcumin nanoparticle gel application. All clinical parameters will be measured and GCF collection will be done at baseline, 1 month, 3 months after scaling and root planing and gel application .The purpose of the study will be explained to every selected patients and his or her written consent will be obtained prior to the commencement of the study. The demographic characteristics of the patients (age & sex), Probing pocket depth (PPD), clinical attachment level (CAL), Plaque index (PI), Gingival Index (GI), Bleeding on probing (BOP) will be recorded before the commencement of procedures. Hence the present study, attempts evaluate the clinical efficacy and total antioxidant capacity of curcumin nanoparticle gel and green tea extract gel as an adjunct to scaling and root planing in treatment of Stage 2 periodontitis

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Subjects who are diagnosed with clinical stage 2 periodontitis, with probing depth greater than or equal to 5mm in at least 3 quadrants, and willing for treatment.
  • Patients with age range of 25-55 years are included in the study and comprises of both sexes.
  • Minimum of 15 teeth should be remaining.

排除标准

  • Systemically compromised patients.
  • Use of antibiotics in the past 6 months Steroid or inflammatory drugs for 7 days in 3 months Known allergy to the above-mentioned drugs/substance Smokers and alcoholic Pregnant and lactating women Periodontal therapy within 6 months.

结局指标

主要结局

To evaluate efficacy of curcumin nanoparticle gel and green tea extract as an adjunct to scaling and root planing on clinical parameters and total antioxidant capacity in GCF of patient with Stage 2 periodontitis.

时间窗: All clinical parameters will be measured and | GCF sample collection will be done at baseline, 1 month and 3 months after the therapy. Gel application will be done at baseline

次要结局

  • To compare the efficacy of curcumin nanoparticle gel and green tea extract gel as an(adjunct to scaling root planing and scaling and root planing alone on clinical)

研究者

发起方
Dr Dikson Kuriakose
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Dikson Kuriakose

Coorg Institute of Dental Sciences

研究点 (1)

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