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临床试验/CTRI/2025/02/080624
CTRI/2025/02/080624尚未招募2/3 期

Clinical Evaluation of Effectiveness of Silver Nanoparticles Derived from Terminalia Arjuna Plant Extract as Photocatalyst in Photodynamic Therapy as an Adjunct to Scaling and Root Planing in the Management of Chronic Periodontitis – A Randomized Control Trial

Dr. Priyanka Dalvi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1. Plaque Index (P.I.)

研究概览

简要总结

Aims and Objective:

To clinically evaluate the effectiveness Silver nanoparticles derived from Terminalia Arjuna plant extract as photocatalyst in photodynamic therapy as an adjunct to Scaling and Root Planing in chronic periodontitis patient by Evaluation of plaque index, gingival index, probing pocket depth and clinical attachment loss.

Introduction:

Periodontitis is an inflammatory disease of the gums that destroys the foundation on which teeth rest. Deterioration of periodontal ligaments (PDLs), the development of periodontal pockets, and the resorption of alveolar bone are hallmarks. Photodynamic therapy (PDT) is a form of phototherapy involving photochemistry, photophysics, and photobiology. In the past few years, therapeutic nanoparticles (NPs), as a developing engineering solution for treating periodontitis, have received extensive attention. NPs possess distinct therapeutic qualities, including exceptional antibacterial, anti-inflammatory, and antioxidant properties, immunomodulatory capacities, and the promotion of bone regeneration ability. Silver NPs (AgNPs) with a size of less than 100 nm and a uniform spherical shape have high and broad-spectrum antimicrobial activity.

The purpose of this study is to Clinically Evaluate the Effectiveness of Silver Nanoparticles derived from Terminalia Arjuna plant extract as Photocatalyst in Photodynamic Therapy as an Adjunct to Scaling and Root Planing in the Management of Chronic Periodontitis – A Randomized Control Trial”

Material and Methods:

The patients fulfilling the inclusion criteria will be divided into two groups using Computer assisted randomization – Group A and Group B

A) Group A: Scaling and Root Planing (SRP) with photodynamic therapy

B) Group B: Scaling and Root planing (SRP) with Photodynamic therapy with silver nanoparticles derived from Terminalia Arjuna plant extract.

Scaling and Root planing (SRP) will be done using Ultrasonic Scaler

Procedure:

Following initial examination and treatment planning, the subjects will be divided into Groups A and B. The baseline details of Gingival, Plaque, Pocket Probing depth, Clinical Attachment level will be noted. After initial examination both the groups will be treated by scaling and root planning followed by photodynamic therapy.

Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software.

Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.

For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non parametric substitute like Mann Whitney U test will be used.

Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test.

Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used.

Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.

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 50.00 Year(s)(—)
性别
All

入选标准

  • systemically healthy adult 25-50 years age group.
  • periodontal pockets greater than 3mm and less than 5mm deep.
  • Patients with chronic periodontitis 3) Patient willing to give the informed consent and willing to comply with the study were selected.

排除标准

  • Systemic diseases- active cancer, photodermatoses, photoallergies, encephalitis, meningitis, hyper/ hypo thyroidism.
  • Pregnancy.

结局指标

主要结局

1. Plaque Index (P.I.)

时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month

(Silness and Loe)

时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month

2. Gingival Index (G.I.) (Loe and Silness, 1963)

时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month

3. Probing Pocket Depth (PPD)

时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month

4. Clinical Attachment Level (CAL)

时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month

次要结局

  • 1. Plaque Index (P.I.)((Silness and Loe))

研究者

发起方
Dr. Priyanka Dalvi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Priyanka Dalvi

Nair Hospital Dental College, Mumbai

研究点 (1)

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