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临床试验/CTRI/2023/02/049678
CTRI/2023/02/049678已完成不适用

Indocyanine Green based antimicrobial Photodynamic Therapy as an adjunct to non-surgical periodontal treatment in periodontal maintenance patients: A clinico-microbiological study

Manipal College Of Dental Sciences, Mangalore1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年2月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
changes in probing pocket depth and clinical attachment level

研究概览

简要总结

The randomised split mouth study comprises of 2 groups diagnosed with periodontitis, enrolled in maintenance program having residual pockets, wherein one group receives only scaling and root planing and the other group receives scaling and root planing along with Indocyanine green based photodynamic therapy. The patients will be recalled after 3 months for assessment of clinical and microbiological parameters.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients who agree to participate in the study by signing the informed consent.
  • Age ≥ 30 years irrespective of gender.
  • Patients diagnosed with stage II and stage III periodontitis having completed active periodontal treatment atleast 3-6 months prior, receiving regularly supportive periodontal therapy (SPT) and exhibiting residual pockets of ≥4mm.
  • Systemically healthy controls Full Mouth Plaque Score 25% Full Mouth Bleeding Score 25%.

排除标准

  • 1.Patients with systemically compromised health like diabetes, that may influence the periodontal status.
  • 2.Use of drugs such as immune-suppressants, anti-epileptic, calcium antagonist 3.Use of antimicrobial mouthrinses in the preceding 2 months 4.Smokers 5.Use of systemic antibiotics in the last twelve months 6.Restorations and superficial caries in the area to be treated.
  • 7.History of allergy of any kind of dye or iodine.
  • 8.Pregnant or lactating women.

结局指标

主要结局

changes in probing pocket depth and clinical attachment level

时间窗: 3 months

次要结局

  • The secondary objective was to compare the changes in detection frequency of Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans and Tannerella forsythia, Fusobacterium nucleatum, in subgingival plaque samples of test and control sites before and after therapy.(3 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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