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临床试验/CTRI/2024/04/066528
CTRI/2024/04/066528尚未招募不适用

The effect of gel containing 2% Ibuprofen and 2% Povidone Iodine on wound healing after periodontal surgery: A Randomized Control Study

KLE Academy Of Higher Education Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月11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
50
试验地点
1
主要终点
Wound Healing Index

研究概览

简要总结

·        One of the major problems in dentistry is the post operative complications; the most common ones are pain, bleeding, infections, swelling and trismus.1 The meticulous assessment and restraining these symptoms, particularly pain and infections, is efficacious to achieve patient’s solace.

·        Pain is an unpleasant emotional experience usually initiated by noxious stimulus and transmitted over a specialized neural network to CNS where it is interpreted as such.2 The pain after operation is increased by inflammation amalgamated with primary repair. The use of non-steroidal anti-inflammatory drugs to control pain is routinely practiced.

·        One of the NSAID’s is Ibuprofen. It is derived from Propionic acid. It acts by inhibiting the enzyme Cyclooxygenase (COX), which is required for synthesis of Prostaglandin (PG) via Arachidonic acid pathway.3

·        An additional embodied aspect is the occurrence of secondary infections. This is encouraged by the microbial activity in the oral cavity. Amongst the different antimicrobial agents, Povidine Iodine has been widely used due to its benefits, including rapid wound healing and broad-spectrum antimicrobial activity against perio pathogens.

·        The antimicrobial activity of Povidine Iodine occurs after the Iodine disassociates from the complex. Once in free form, Iodine rapidly penetrates microbial cell membrane and interacts with proteins, nucleotides and fatty acids in the cytoplasm and cytoplasmic membrane. This interaction ultimately results in rapid cell death.4

·        In the management of periodontal flap surgeries, in order to obtain high antimicrobial activity and low systemic complications local drug delivery system can be used. One such drug delivery agent is gel form.

·        Gels are semisolid devices containing an adequate concentration of drug and delivered at specific sites. They are easy to prepare and administer. They further possess a property of bio adhesivity that enhances the retention time at the operated site.5

·        Acknowledging the aforementioned advantages of the gel form, it might be prudent to utilize the analgesic effect of Ibuprofen and antimicrobial properties of Povidine Iodine as the fundamental elements of the gel.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

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 in between the age group of 25-60 years.
  • Patients with chronic periodontitis indicated for flap surgery.
  • Patients who give informed consent for the study.

排除标准

  • Exclusion criteria:
  • Patients with history of any systemic diseases.
  • Patients who are lactating mothers and pregnant women.
  • Patients who have undergone any periodontal therapy 6 months prior to the study.
  • Patients who have taken any anti-inflammatory drugs, antibiotics or mouth rinse over past 3 months.
  • Patients with known hypersensitivity to Ibuprofen or Povidine Iodine.

结局指标

主要结局

Wound Healing Index

时间窗: Wound Healing Index- 1st day,2nd day, 3rd day, 7th day & 14th day

次要结局

  • Visual Analog Scale(Visual Analog Scale 1st day,2nd day, 3rd day & 7th day)

研究者

发起方
KLE Academy Of Higher Education Research
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Unnati Nayak

KLE University

研究点 (1)

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