Evaluation of Photodynamic therapy using Indocyanine green and Methylene Blue in reducing Enterococcus Faecalis and Porphyromonas Gingivalis in Endo-perio lesions.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ATP RLU values and microbiological analysis of Porphyromonas gingivalis and Enterococcus faecalis from the rootcanal and periodontal pocket
研究概览
简要总结
Antimicrobial photodynamic therapy has been introduced as a promising and non invasive local and adjuvant treatment in several oral infectious diseases. It is a strategy that involves the chemical interaction of a topical nontoxic photosensitizer and a light source with a specific wavelength. The excited photosensitizer reacts with the molecular oxygen from the environment to generate highly reactive oxygen species, causing, among other factors, bacterial cell wall rupture and bacteria death. Its efficacy for elimination of bacterial, fungal, and viral infections and key pathogens such as Streptococcus mutans, Porphyromonas gingivalis, Candida albicans and Enterococcus faecalis.
Methylene blue, Curcumin, and Indocyanine green are the most common commercially available PS. They are chemical compounds, disinfectants, and antiseptics used as dyes or indicators in oxirreduction reactions. Methylene Blue has photosensitizing characteristics and an absorption range of 500 nm to 700 nm, being activated by red light. Methylene Blue was chosen as the photosensitizer since its activity against oral bacteria is known and has reported clinical application.
Indocyanine Green has gained special attention as a new PS due to its low toxicity and activation near the infrared spectrum. Its absorption peak at 810 nm coincides with commercially available laser diodes for dental use, which penetrate deeper than a red laser, thus favoring the elimination of bacteria during endodontic treatment.
The AIM of the study is to Evaluate the effect of Photodynamic therapy using Indocyanine green and Methylene Blue in reducing Enterococcus Faecalis and Porphyromonas Gingivalis in Endo-perio lesions.
Total of 40 Maxillary and mandibular Premolar and Molar teeth with endo-perio lesions (pulp necrosis) in systemically healthy subjects will be taken into the study. They will be assigned into 2 groups consisting of 20 in each with one site in each patient.
Group I (n= 20): Indocyanine green irrigation (ICG) placement in canal and periodontal pocket followed by laser irradiation.
Group II (n=20): Methylene Blue (MB) placement in canal and periodontal pocket followed by laser irradiation.
analysis of plaque index, probing pocket depth, clinical attachment level and microbiological analysis of Porphyromonas gingivalis and Enterococcus faecalis from periodontal pocket at baseline and 3 months post operative
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age between 21-55 yrs.
- •2 presence of at least 20 permanent teeth.
- •3 Presence of pocket depth ≥ 5mm.
- •4 Non-vital tooth (pulp necrosis) 5 Presence of radiolucency at peri-apical area with evidence of bone loss from marginal bone to root apex.
- •6 Radiolucency without root damage.
- •7 Adult patient who did not received any active periodontal or endodontic treatment in the teeth undergoing treatment.
排除标准
- •1•Tooth with mobility.
- •2•Individuals with tobacco use, 4•pregnancy or lactation.
- •5•Use of NSAIDS and antibiotics within the previous 3 months.
- •6•Suffering with CVD, renal disease, diabetes and hypertension 7•Syndromes or developmental disorders with periodontal disease 8•Horizontal and vertical fractures.
- •9•Iatrogenic root perforations.
- •10•Open apices.
- •11•Tooth that could not be isolated with rubber dam.
结局指标
主要结局
ATP RLU values and microbiological analysis of Porphyromonas gingivalis and Enterococcus faecalis from the rootcanal and periodontal pocket
时间窗: at baseline and 3 months post-operative
次要结局
- Plaque Index, Probing Depth, and Clinical attachment Level(at baseline and 3 months post-operative)
研究者
Katuri Kishore Kumar
sibar institute of dental sciences