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临床试验/CTRI/2024/03/064817
CTRI/2024/03/064817尚未招募3 期

Comparative analysis of the antimicrobial effect of Low Level Light Therapy versus Systemic Antimicrobials as an adjunct in the non surgical treatment of Stage 3 & 4 Periodontitis A Procalcitonin guided randomised controlled trial

Benedicta Theresa Abraham1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年4月8日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
Serum Procalcitonin, Serum CRP

研究概览

简要总结

Periodontitis is a chronic infectious disease, in which the microbial biofilm plays a significant role, resulting in inflammation within the supporting tissues of the teeth and if left untreated, will ultimately lead to tooth loss. The management centers on the mechanical disruption of the biofilm and systemic antimicrobials. However, there are significant limitations to antimicrobial therapy, especially multidrug resistance, patient compliance, overt use of antimicrobials and poor efficacy against the biofilm. The objectives of this study is to determine the CRP and PCT levels in Periodontitis Stage 3 and Stage 4 patients. To evaluate the reduction in CRP and PCT levels after Non Surgical Periodontal Therapy (NSPT), NSPT + adjunctive antimicrobials, NSPT + adjunctive LLLT and to compare the reduction in CRP and PCT levels among the three groups. Participants will be grouped into two groups- Group 1- Periodontally Healthy Group (Control) (n=16) and Group 2- Periodontitis Stage 3 and 4 Group (Test) (n=48).  Standardized serum samples will be collected from both groups to determine the values of CRP and PCT. Only Group 2, treatment group participants whose PCT values >0.25ng/mL will be included in the interventional randomized control trial. Standardized sub-gingival plaque samples from Group 2 participants will be collected for microbial analysis. Group 2 participants will be further sub grouped into three subgroups based on the interventions- A) NSPT (n=16), B) NSPT along with systemic antimicrobials (n=16), C) NSPT along with Low Level Light Therapy (n=16). A 400-500nm blue light source with power outputs ranging from 50-500mW, equipped with a probe tip will be used. It will be placed at the depth of the pocket and moved circumferentially around the tooth.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

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

入选标准

  • Age: 45 -60yrs
  • Stage 3 & Stage 4 Periodontitis patients (According to AAP & EFP 2017 Classification)
  • Minimum of 20 teeth, excluding third molars to be present.

排除标准

  • Any systemic or debilitating disease affecting periodontal health.
  • Immunocompromised patients
  • Regular NSAIDS and Aspirin use
  • Regular anti-inflammatory medication use
  • Antimicrobial use in the last three months
  • Antimicrobial mouthwash use in the last three months
  • Surgical periodontal treatment in the last three months
  • Pregnant or lactating women
  • Former or current smokers
  • Former or current alcoholics
  • Active carious lesions.

结局指标

主要结局

Serum Procalcitonin, Serum CRP

时间窗: Baseline, 4 weeks and 12 weeks

次要结局

  • Plaque index, Gingival index,Probing pocket depth, CAL, RAL(baseline, 1 month, 3 months)

研究者

发起方
Benedicta Theresa Abraham
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Benedicta Theresa Abraham

Bangalore Institute of Dental Sciences and Hospital

研究点 (1)

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