跳至主要内容
临床试验/CTRI/2024/09/073681
CTRI/2024/09/073681尚未招募不适用

Comparative evaluation of antimicrobial effect of indocyanine green and methylene blue dye as photosensitizers for photodynamic therapy as an adjunct to scaling and root planing in patients with moderate periodontitis - A randomized controlled trial

Dr Jasleen Thakker1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年9月26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
63
试验地点
1
主要终点
Gingival index, Pocket probing depth, Clinical attachment loss

研究概览

简要总结

Ø  The primary goal of periodontal therapy is to eliminate bacterial biofilm and endotoxins from root surfaces of the teeth. However, owing to anatomical variations in root surfaces, complex furcation areas, concavities on root surfaces, and bacterial invasion of the surrounding soft tissues, nonsurgical periodontal therapy (NSPT) alone cannot eliminate periodontal pathogens.1

Ø  Although systemic and local administration of antibiotics into periodontal pockets may be effective for disinfection, the frequent usage of antibiotics bears the potential risk of producing resistant microorganisms.1

Ø  In recent years, photodynamic therapy (PDT) with the help of lasers has been used to decontaminate the pocket environment as it is a minimally invasive treatment that activates the immune system, has low systemic toxicity, and possesses high bactericidal properties. The eradication of tissue invasive microorganisms associated with periodontitis and peri-implantitis by lasers has been amply demonstrated.2

Ø  Combining lasers and photosensitizing agents can result in photo destruction of target cells due to cytotoxic effect in the presence of oxygen. This light-induced effect is due to the conversion of the excited photosensitizer from the ground state to the triplet state resulting in production of singlet oxygen and other reactive agents, which are very toxic to certain cells or bacteria.3

Ø  A recent in vitro study had shown the efficacy of a new photosensitizer dye, indocyanine green (ICG), against Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis, when activated at a wavelength of 810 nm by a diode laser. It has high absorption in the infrared spectrum, low toxicity, and rapid elimination.4

Ø  Methylene blue has a strong absorption band in the 550-700 nm region and has been extensively used for photooxidation of natural and synthetic molecules. Fontana et al, in 2009, demonstrated aPDT with 25 μg/mL methylene blue and red light resulted in 63% reduction of planktonic bacteria and 32% decrease in bacteria forming biofilms.5

Ø  The photokilling rate in antimicrobial photodynamic therapy is highly related to interaction of reactive oxygen species (ROS) produced, ability of photosensitizers (PS) in incorporating into microorganisms and light devices/microorganism type.6

Ø  While methylene blue and indocyanine green are present in the dental practice as PS there is an acute paucity of literature comparing their efficacy in terms of improvement of clinical parameters and suppression of periodontal pathogens. Therefore, the present study aims at comparative evaluation of antimicrobial effect of indocyanine green and methylene blue dye as photosensitizers for photodynamic therapy as an adjunct to scaling and root planing in patients with moderate periodontitis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Non smoking adults more than 18 years of age Patients with minimum 20 teeth present Untreated moderate periodontitis with probing depth more than or equal to 5mm & less than 7mm, presence of bleeding on probing and clinical attachment loss of 3mm to 4mm.
  • Signed informed consent.

排除标准

  • Pregnant or lactating women.
  • Periodontal treatment in the past 6 months.
  • Patients allergic to the use of dyes.
  • Patients presenting with a history of ocular problems.

结局指标

主要结局

Gingival index, Pocket probing depth, Clinical attachment loss

时间窗: Baseline, 1 week, 1 month

次要结局

  • Colony forming units/ml(Baseline, 1 week, 1 month)

研究者

发起方
Dr Jasleen Thakker
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Dr Jasleen Thakker

KAHERs KLE V.K Institute of Dental Sciences

研究点 (1)

Loading locations...

相似试验