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临床试验/CTRI/2025/06/089764
CTRI/2025/06/089764尚未招募不适用

Efficacy of liquorice-infused chitosan local drug delivery system in chronic periodontitis – a randomized controlled clinical trial.

Isvarya E S1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To develop a liquorice coated chitosan chip.

研究概览

简要总结

Evaluating the efficacy of a liquorice-infused local drug delivery (LDD) chip as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis. The study is designed as a randomized controlled clinical trial using a split-mouth design, where 20 patients with chronic periodontitis provide both test and control sites. The test group receives SRP along with the liquorice-coated chitosan chip, while the control group receives SRP along with chitosan chip. The liquorice extract is prepared using the Soxhlet extraction method and infused into a chitosan membrane to form the chip. In vitro analyses include FTIR and gas chromatography for composition, cytotoxicity testing using human fibroblast cell lines, and drug release studies using the dialysis membrane method. Clinically, the study evaluates parameters such as the gingival index (GI), plaque index (PI), probing pocket depth (PPD), and clinical attachment level (CAL) before and after treatment. This research aims to develop a natural, biocompatible, and effective adjunctive therapy to improve periodontal treatment outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 30 to 60 years old systemically healthy participants.
  • Chronic periodontitis patients with at least one site with a pocket depth of more than 5mm and a CAL of 3 to 4 mm.

排除标准

  • History of systemic disease.
  • Smokers and tobacco chewers.
  • Pregnant and lactating females.
  • Periodontal therapy within 6 months.
  • History of Antibiotics for the past 3 months.

结局指标

主要结局

To develop a liquorice coated chitosan chip.

时间窗: 0 days to 3 months

To analyse the cytotoxicity, composition and drug release of liquorice coated chitosan chip.

时间窗: 0 days to 3 months

次要结局

  • To evaluate the clinical effectiveness of liquorice infused chitosan chip when used as an adjunct to SRP in patients with chronic periodontitis.

研究者

发起方
Isvarya E S
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Isvarya ES

KSR Institiute of Dental Science And Research

研究点 (1)

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