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临床试验/CTRI/2024/08/073116
CTRI/2024/08/073116已完成3 期

Effect of intrasocket application of hyaluronic acid on pain, swelling and trismus after surgical extraction of impacted mandibular third molar

Krishna Vishwa Vidyapeeth1 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10日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Swelling

研究概览

简要总结

Mandibular third molar removal is one of the most widely done treatments in the oral cavity. Nevertheless, surgeons often encounter undesirable post-operative sequalae. These inflammatory responses after wisdom teeth surgery may badly affect a patients’ quality of life.

Post-operative complications like dry socket, nerve damage, bone fracture, delayed healing and damage of the second molar can also happen quite frequently following the surgical removal of mandibular third molars .Though traditional measures such as non steroidal anti-inflammatory drugs and corticosteroids proposed for control of postoperative complications work well ,their potential side effects have led to search for  an easy applicable way  to reduce post-operative pain and swelling.

Hyaluron or hyaluronic acid is a biomaterial that has been introduced as an alternative approach to enhance wound healing. Hyaluronic acid is a major carbohydrate having multifaceted roles. It plays a critical role in wound healing by inducing early granulation tissue formation, inhibiting destructive inflammation and promoting angiogenesis. Owing to its non-immunogenic and non-toxic properties, it has been used in ophthalmology, dermatology, and rheumatology and now has been introduced for intraoral use. It is available in gel or  liquid form to be applied topically in oral cavity.The study aims  to determine the effect of intra socket hyaluronic acid application  on post extraction pain, swelling and trismus after surgical removal of 3rd molar .

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 45.00 Year(s)(—)
性别
All

入选标准

  • Patients with mesioangular impacted mandibular third molar with moderate difficulty index according to Pederson difficulty index.
  • Patient willing for participation in study.

排除标准

  • Patients outside the 18 – 45 years age group.
  • Those with signs of peri-coronitis and/or pain before surgery.
  • Those with allergy to Hyaluronic acid.
  • Medically compromised patients Patients having osteopetrosis, osteoporosis, osteoradionecrosis or any bone pathology.

结局指标

主要结局

Swelling

时间窗: baseline | 1st post op day | 3rd post op day | 7th post op day

Pain

时间窗: baseline | 1st post op day | 3rd post op day | 7th post op day

Trismus

时间窗: baseline | 1st post op day | 3rd post op day | 7th post op day

次要结局

  • Number of analgesic consumed by patient(1,3,7 day)

研究者

发起方
Krishna Vishwa Vidyapeeth
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Deepshikha Bhave

Krishna Vishwa Vidyapeeth

研究点 (1)

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