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临床试验/CTRI/2025/03/083028
CTRI/2025/03/083028已完成3 期

"COMPARATIVE EVALUATION OF EFFICACY OF INDOCYANINE GREEN AND METHYLENE BLUE MEDIATED ANTIMICROBIAL PHOTODYNAMIC THERAPY AS AN ADJUNCT TO NON-SURGICAL TREATMENT OF PERIODONTITIS. A CLINICO-MICROBIAL STUDY”

未提供1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Plaque index

研究概览

简要总结

Photodynamic therapy (PDT) is an oxygen dependent photochemical reaction that occur upon light mediated activation of a photosensitizing compound leading to generation of cytotoxic reactive oxygen species.PDT has emerged in recent years as a non-invasive therapeutic option.Many photosensitizers like methylene blue, toluidine blue has proven to be effective. But certain disadvantages linked to these agents, such as, incidental staining, need to purchase of separate laser units etc., establish the need for a potential new photosensitizer transcending these disadvantages.A Food and Drug Administration (FDA) dye, Indocyanine green (ICG) was used in hepatic function diagnostics, fluorescent angiography in ophthalmology and later in cardiology had become established as new in dentistry.A new photosensitizer called indocyanine green (ICG) has been developed which gets activated upon absorbing light of specific wavelength. The fact that ICG does not require oxygen can make it even more effective in anaerobic subgingival area as compared to other photosensitizers and used for the treatment of periodontitis.The disadvantages of earlier dyes, better efficiency and safety with ICG and successful in vitro studies using this dye against periopathogenic bacteria, led to present studies.

Not many studies have been conducted using ICG dye to study effect of aPDT in periodontitis.Not many studies have been conducted to compare the clinical and microbial efficacy between ICG and methylene blue.

The present study helps to evaluate the clinical and microbiological effects of ICG mediated aPDT as an adjunct to non-surgical management of chronic periodontitis.

And to evaluate and compare the clinical and microbiological effects between ICG(1mg/ml) and Methylene blue (1%) using low power diode laser (0.8W, 940nm) in the management of chronic periodontitis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Patients with minimum 20 teeth.
  • Patients with Stage II Grade A periodontitis having at least 3 teeth with probing depth of 5 mm.

排除标准

  • Consumption of tobacco in any form.
  • Pregnant and lactating women.
  • Patients taking medications that may interfere with periodontal therapy.
  • Previous history of allergic reaction to the use of any kind of dye.

结局指标

主要结局

Plaque index

时间窗: At baseline, 1 and 3 months

Gingival index

时间窗: At baseline, 1 and 3 months

Probing pocket depth

时间窗: At baseline, 1 and 3 months

Clinical attachment level

时间窗: At baseline, 1 and 3 months

次要结局

  • Microbial analysis of total viable anaerobic count (TVAC)(At baseline, 1 and 3 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr K SUNEETHA

Drs. Sudha and Nageswara rao Siddartha institute of dental sciences

研究点 (1)

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