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临床试验/CTRI/2024/02/062302
CTRI/2024/02/062302尚未招募不适用

Assessment of post-surgical healing and patient reported outcomes of adjunctive systemic enzyme therapy after periodontal flap surgery- A randomized clinical trial

Garapati Nitya sri1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年2月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Early wound healing score (EHS)

研究概览

简要总结

Title**:**Assessment of Postsurgical healing and patient reported outcomes of systemic enzyme therapy after periodontal flap surgery- A  randomized clinical trial

Objectives:

To evaluate the effectiveness of systemic enzyme therapy post surgically in patients after periodontal flap surgery

To compare and evaluate the effectiveness of systemic enzyme therapy against NSAIDs among post operative healing and pain after periodontal flap surgery

Methodology

The objectives of the present study are (1) to assess healing after periodontal surgery using Early wound healing score (EHS) at 7, 14, and 30 days postoperatively, and (2) to assess pain after periodontal surgery using Visual Analog Score (VAS) at 7, 14 days postoperatively, and (3)to compare the post operative healing and pain between groups.

Source of the data:Patients attending Vishnu dental college.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients with persistent probing pocket depths of ≥5mm in at least four adjacent teeth (Periodontitis Stage II, III and Grade B, C).

排除标准

  • 1.Patients who have any active infections i.e., periapical, periodontal or odontogenic lesion 2.Any allergic reactions to the components of the systemic enzyme supplement 3.Severe congenital or acquired coagulation disorders (e.g. hemophilia, in dialysis patients) or liver damage, 4.Pregnancy or breastfeeding, 5.Any clinical signs or laboratory evidence for severe inflammatory, endocrine, renal/pulmonary, neurological, cardiovascular, metabolic, gastrointestinal, hematological, or psychiatric condition 6.Active malignancy of any type 7.Current use of anticoagulants or platelet aggregation inhibitors, chemotherapeutic agents, antibiotics, medication for lipids, diabetes, hypertension, inflammation, autoimmune diseases, mood disorders 8.Use of NSAID within 1 month of entering the study, 9.Alcoholism, smoking, 10.Current use of nutritional supplements.

结局指标

主要结局

Early wound healing score (EHS)

时间窗: T1-7days post surgically | T2-14 days post surgically | T3-30days post surgically

次要结局

  • Pain using Visual analog scale (VAS)(T1-7 days post surgically)

研究者

发起方
Garapati Nitya sri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr N V S Sruthima G

Vishnu Dental College

研究点 (1)

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