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临床试验/CTRI/2022/08/045099
CTRI/2022/08/045099招募中3 期

Effectiveness of photodynamic therapy using indocyanine green on microbial and procalcitonin levels in periodontitis patients - A comparative split mouth randomized controlled clinical trial

Bangalore Institute of Dental Sciences and Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年2月9日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
22
试验地点
1
主要终点
1.compare and assess the microbial and biochemical parameters like BAPNA analysis on subgingival plaque samples and ELISA on GCF samples among SRP , SRP AND LASER , SRP AND PHOTODYNAMIC THERAPY groups in periodontitis patients

研究概览

简要总结

Antimicrobial photodynamic therapy is being widely used in different therapeutic procedures in dentistry and medicine.’ Red complex bacteria have been seen to play a major role in controlling the biofilm in deep periodontal pockets thus having a major role in both initiation and progression of pocket depth. Indocyanine Green (ICG) offers the advantage of being active in deep pockets where these red complex bacteria’sthrive. ICG has demonstrated promising results in vitro studies specifically targeting the red complex periopathogens.Very limited studies have been done to evaluate the effect of PDT using ICG in-vivo. Serum procalcitonin is a potent marker for bacterial infections in the field of medicine. Recent articles suggest the utility of using GCF Procalcitonin levels as a marker for not just periodontal disease activity but also as an indicator for microbial activity.Hence, this novel study is designed to evaluate the effectiveness of diode laser and indocyanine green mediated photodynamic therapy as an adjunct to scaling and root planing on the red complex microflora and associated changes in GCF Procalcitonin levels in periodontitis patients. The additional microbial testing will help strengthen the decision making which was earlier based on clinical and inflammatory markers alone.

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 and Investigator 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

  • 1.patients with minimum 20 teeth present in the oral cavity .
  • periodontal pocket depth 5-6mm in minimal 3 sites ( one in each quadrant ).

排除标准

  • 1.smokers 2.3rd molars 3.patients who have undergone periodontal therapy in last 6 months.
  • 4.patients who have received antibiotic therapy in previous 3 months.
  • 5.medically compromised patients 6.patients with known history of allergy 7.pregnant and lactating women.

结局指标

主要结局

1.compare and assess the microbial and biochemical parameters like BAPNA analysis on subgingival plaque samples and ELISA on GCF samples among SRP , SRP AND LASER , SRP AND PHOTODYNAMIC THERAPY groups in periodontitis patients

时间窗: 0 and 3 months

次要结局

  • to assess the clinical parameters like plaque index, gingival index, probing pocket depths , clinical attachment level and relative attachment level in periodontitis patients(0 and 3 months)

研究者

发起方
Bangalore Institute of Dental Sciences and Hospital
申办方类型
Private hospital/clinic

研究点 (1)

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