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临床试验/NCT06713733
NCT06713733招募中不适用

Comparison of Clinical Efficacy of Submucosal Dexamethasone and Oral Trypsin-chymotrypsin for Reduction of Postoperative Sequelae After Lower Third Molar Surgery

B.P. Koirala Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
comparison of clinical efficacy of submucosal dexamethasone and oral trypsin-chymotrypsin for reduction of postoperative sequelae after lower third molar surgery

研究概览

简要总结

Pain, edema and trismus are the most frequent postoperative sequelae to surgical removal of impacted teeth, all of are due to the local inflammatory response.

Use of corticosteroids decrease tissue mediators of inflammation and reduce edema.

Use of trypsin-chymotrypsin elaborates the enzymes esterase in blood plasma that inhibits inflammation by hydrolytic degradation of the inflammatory peptides.

详细描述

Impacted tooth is a tooth which is completely or partially unerupted and is positioned against another tooth, bone or soft tissue so that its further eruption is unlikely, described according to its anatomic position.

Surgical extraction of the impacted mandibular third molars is the most common procedure in oral surgery clinics. Most of the common postoperative complications following lower third molars surgery are pain, trismus and facial swelling. Adequate surgical methods such as selecting an appropriate flap design, minimal bone removal and less trauma to adjacent soft tissues with proper wound closure techniques could decrease the incidence of postoperative sequelae, but not eliminate it.

surgical edema is expected sequel of removal of impacted lower wisdom tooth. Swelling usually reaches at its maximum on 2nd and 3rd postoperatively day and should start reducing by 4th day. Swelling completely resolves by the 7th to 9th day.

Corticosteroids are routinely employed to control the sequelae of inflammation in third molar surgeries. Steroids prevent diapedesis, the initial leakage of fluids from the capillaries, and stabilize the membranes of the cellular lysosomes which hold large quantities of hydrolytic enzymes. There is also a decrease in the formation of bradykinin, a powerful vasodilating substance. Steroids act by suppression of leucocyte and macrophage accumulation at the inflammatory site by interfering with capillary dilatation, fibrin deposition and prevention of prostaglandin synthesis by inhibiting the arachidonic acid cascade.

Trypsin-chymotrypsin is proteolytic enzymes that acts as anti-inflammatory agents. The concentration of enzymes determined as esterase in blood plasma is increased after trypsin chymotrypsin administration. Since the inflammatory process is thought to be due to peptides elaborated at the site of tissue trauma, it has been postulated that the increased blood esterase due to trypsin chymotrypsin administration inhibits inflammation by hydrolytic degradation of the inflammatory peptides.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

PI does not have access to any of the groups. i.e PI is blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically healthy patients (ASA I) patient free of any systemic diseases that could interfere with wound healing or surgical operation.
  • Free of any recent anti-inflammatory drug intake or being under long term treatment with medicaments that will obscure the assessment of the inflammatory response as NSAIDs, steroids, or antihistamines
  • Free from allergy to the drugs used in the study
  • Patients requiring surgical removal of the mandibular impacted third molar

排除标准

  • Patients who are ASA II to ASA VI.
  • Patients already on corticosteroids through any route.
  • Patients with known allergy to any drugs.
  • Pregnant and lactating females
  • Patient not consenting to participate in the study

研究组 & 干预措施

Dexamethasone

Active Comparator

submucosal dexamethasone is quite simple, less invasive, painless, convenient for the surgeon and offers a low cost solution. Submucosal injection offers advantage of concentrating the drug near the surgical area with less systemic absorption and no further manipulation of the tissues.

preoperative submucosal dexamethasone 8mg prior to incision locally.

干预措施: Dexamethasone (Drug)

Chymotrypsin

Active Comparator

oral trypsin chymotrypsin is proteolytic enzymes.

1 tab given 30 minutes prior to incision and 1 tab for three times a day for 5 days after extraction.

干预措施: Chymotrypsin (Drug)

结局指标

主要结局

comparison of clinical efficacy of submucosal dexamethasone and oral trypsin-chymotrypsin for reduction of postoperative sequelae after lower third molar surgery

时间窗: 3 months

previous study had shown submucosal dexamethasone is more effective than oral trypsin chymotrypsin

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DR. SABIN BANIYA

DR.SABIN BANIYA

B.P. Koirala Institute of Health Sciences

研究点 (1)

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