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临床试验/CTRI/2025/08/092346
CTRI/2025/08/092346已完成2/3 期

COMPARISON OF EFFICACY OF COLD SALINE IRRIGATION, NORMAL SALINE IRRIGATION WITH ORAL ENZYME PREPARATION AND NORMAL SALINE IRRIGATION WITH SUBMUCOSAL DEXAMETHASONE INFILTRATION ON POST OPERATIVE SYMPTOMS AFTER SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLAR - A RANDOMIZED CONTROLLED TRIAL

Rishabh Yadav1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Post operative swelling

研究概览

简要总结

Third molar surgical removal is one of the most common procedures performed by Oral & Maxillofacial surgeons, it is often associated with post operative swelling, pain and trismus which are inflammatory signs and symptoms that cause discomfort and also can have an impact on quality of life

To reduce post operative discomfort, different pharmacological managements have been proposed by various authors;

Normal saline is commonly used as a irrigating solution in third molar surgeries as it decreases the heat generated by surgical drill while contacting bone thus reducing the chance of inflammation and tissue damage

In some studies, surgeons prefer cold saline irrigation  (2-8 degree celsius) and they believe that it is more effective than normal saline irrigation.

Corticosteroids have been used most frequently for post operative management after 3rd molar surgeries, dexamethasone is most commonly used for post operative swelling , pain and trismus the conventional route for dexamethasone drug delivery is through intramuscular and intravenous route ,however these techniques require additional clinical skills and may not be as pleasant to the conscious patient as well.

As an alternative submucosal injection (SM) has been reported to be an effective , convenient and straightforward way of administering dexamethasone

Nonsteroidal Anti-inflammatory drugs have often been prescribed to reduce post operative inflammatory complications caused by third molar surgery, however the side effects associated are numerous primarily gastro intestinal, renal disorders , propensity to cause skin and mucosal reactions.

Hence a natural, effective, and safe remedy that lacks undesirable side effects would offer a better alternative treatment

Bromelain is a proteolytic enzyme derived from stem of pineapple plant( Ananas Comosus) and presents anti-inflammatory anti edemic and anti fibrinolytic  properties , which can be beneficial in post operative management after 3rd molar surgery.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • pt belonging to the age group of 18-40 years .
  • pt who have not used any antibiotic, anti-inflammatory 1 week before the surgery 3)pt with mild to moderate surgical difficulty on evaluation according to Pederson difficulty index score 3-4 and 5-7 4) pt with normal bleeding and clotting time 5) pt who are non smokers 6)pt with ASA 1 category 7) pt having indication for extraction of impacted mandibular third molar.

排除标准

  • pt who are not willing to participate or take part in the study.
  • pt with previous allergies to anaesthetic agents used.
  • pregnant or lactating female patients.
  • pt who are immunocompromised or suffering from any systemic conditions.
  • pt having bacterial and fungal infection 6) pt allergic to corticosteroids.
  • pt on anticoagulant drugs.

结局指标

主要结局

Post operative swelling

时间窗: 3rd and 7th day

次要结局

  • Post operative pain(3rd & 7th day)
  • Post operative trismus(3rd & 7th day)

研究者

发起方
Rishabh Yadav
申办方类型
Other [self funding]
责任方
Principal Investigator
主要研究者

Rishabh Yadav

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY KLE VK INSTITUTE OF DENTAL SCIENCES, BELAGAVI

研究点 (1)

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