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临床试验/CTRI/2019/07/020454
CTRI/2019/07/020454尚未招募不适用

Effect of Nano crystalline Silver membrane on early wound healing after Periodontal surgery- A Comparative Randomized study

Kanika Aggarwal1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年7月31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
42
试验地点
1
主要终点
Clinical comparison of early wound healing parameters following periodontal surgery using nanocrystalline silver membrane

研究概览

简要总结

This is a randomized clinical interventional study to be performed in the Department of Periodontics on the patients suffering from Chronic Periodontitis indicated for Periodontal Flap surgery with a sample size of 42 subjects(21 in each group). The subjects will be divided into two groups. One group will receive a eugenol free periodontal dressing after the surgery and other group will receive nanocrystalline silver membrane below the eugenol free dressing. The clinical parameters of wound healing will be assessed at 7, 14 and 21 days post surgery using Healing Index by Landry, Turnbull and Howley .Secondary outcomes that will be measured are Total Colony Count below the dressings and measurement of a biomarker VEGF through ELISA, both at baseline and 7 days post surgery. The aim of the study is to assess wound healing capacity and anti-microbial effect of silver nanocrystalline membrane below the periodontal dressing given after the periodontal surgery.

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
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Presence of chronic periodontitis indicated for periodontal flap surgery 2.Non-smoking
  • Teeth vital or properly treated with root canal therapy
  • Absence of inadequate restorations.
  • Patients who give consent
  • Patients with minimum 20 teeth.

排除标准

  • Patients chronically treated (i.e., 2 week or more) with any medication that affect periodontal status (i.e., antibiotics or non-steroidal anti-inflammatory drugs), with clinically significant or unstable organic diseases or compromised healing potential (i.e., connective tissue disorders or bone metabolic diseases)
  • Patients allergic to Silver
  • Pregnant women or lactating
  • Patients affected by active infectious diseases, immune-compromised, or taking steroid medications
  • Patients with less than 20 teeth
  • Patients who do not give consent.

结局指标

主要结局

Clinical comparison of early wound healing parameters following periodontal surgery using nanocrystalline silver membrane

时间窗: Baseline, 7 days, 14 days and 21 days

次要结局

  • 1.Evaluation and comparison of total colony count of microbial flora beneath the nanocrystalline silver membrane and eugenol free dressing alone.(2.Evaluation and comparison of the immunological parameters)

研究者

发起方
Kanika Aggarwal
申办方类型
Other [self]

研究点 (1)

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