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临床试验/CTRI/2024/09/073534
CTRI/2024/09/073534已完成不适用

Comparative evaluation of antimicrobial Photodynamic Therapy as an adjunct to Periodontal surgery in intrabony defects: a randomised controlled trial

Rameshwari Singhal1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Reduction in pocket probing depth clinical attachment loss and MMP1 levels healing dynamics

研究概览

简要总结

The present study is planned to understand the role of photodynamic therapy in reducing microbial load and promoting regeneration when used as an adjunct to minimally invasive periodontal surgical procedures in interproximal intra-bony defects and to compare it with the conventional regenerative periodontal surgery. It will be a split mouth randomized controlled trial and will be followed up for a span of 6 months where healthy patients with pocket probing depth greater than or equal to 5mm and clinical attachment loss greater than or equal to 6mm will be enrolled. We shall be assessing the outcomes through various clinical parameters such as  pocket probing depth clinical attachment loss plaque index gingival bleeding index wound healing index and other factors like patient perceived satisfaction. It works on the hypothesis antimicrobial photodynamic therapy leads to reduction in pocket probing depth clinical attachment loss and bone fill along with better healing dynamics reduction in microbial load as well as MMP1 compared to conventional regenerative therapy.

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 Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Adults between 18 to 50 years of age Bilateral defects with probing depth greater than 5mm and clinical attachment level greater then equal to 6mm associated with an intrabony defect greater than equal to 3mm Full mouth plaque scores and full mouth bleeding scores 20 percent after non surgical periodontal therapy Nonsmokers or former smokers who have not smoked within 6 months of study initiation Vital or root canal treated tooth with no associated endodontic pathology.

排除标准

  • Patients with clinically significant or unstable systemic diseases or compromised healing potential Patients with history of antibiotic nonsteroidal antiinflammatory medication or on drug affecting periodontal status for greater than equal to 2weeks prior to enrolment in the study Pregnant or lactating women History of periodontal surgery within last one year of enrolment.

结局指标

主要结局

Reduction in pocket probing depth clinical attachment loss and MMP1 levels healing dynamics

时间窗: Reduction in pocket probing depth clinical attachment loss and MMP1 levels healing dynamics at baseline and 21days 3months and 6months

次要结局

  • patient perceived satisfaction(6months)

研究者

发起方
Rameshwari Singhal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rameshwari Singhal

King Georges Medical University

研究点 (1)

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