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临床试验/CTRI/2025/08/093149
CTRI/2025/08/093149招募中3 期

Comparison Of Efficacy Of Submucosal Injection Of Tramadol Vs Dexamethasone In Reducing Post Operative Sequelae In Impacted Mandibular Third Molar Extraction : A Prospective, Randomised, Placebo Controlled, A Triple Blind Study.

chatoi socia1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月27日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
1) Reduction in swelling.

研究概览

简要总结

**Background:**Surgical removal of impacted mandibular third molars is frequently associated with postoperative sequelae such as pain, swelling, and trismus, which can significantly affect patient comfort and quality of life. Various pharmacological agents have been evaluated to minimize these outcomes. This study aims to compare the efficacy of submucosal injection of tramadol versus dexamethasone in controlling postoperative discomfort following third molar surgery.

Materials and Methods: A prospective, randomized, placebo-controlled, triple-blind clinical trial was conducted on 90 systemically healthy patients requiring mandibular third molar extraction. Patients were randomly allocated into three groups (n=30 each): Group A received 1 ml of tramadol (50 mg/ml), Group B received 1 ml of dexamethasone (4mg/ml), and Group C received 1 ml of normal saline (placebo) via submucosal injection immediately post-extraction. Standardized surgical protocol and postoperative care were maintained. Pain (measured using a Visual Analog Scale), facial swelling (measured using two-line facial measurement), and trismus (interincisal distance) were assessed on postoperative days 1, 3, and 7.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1 Above 18 years of age, any sex.
  • 2 Impacted mandibular third molar (which require transalveolar extraction) with Pederson difficulty index- moderately difficult (5-7) 3 American Society of Anesthesiologists (physical status classification)- class 1.

排除标准

  • • Age below 18 years • Patient with history of any systemic illness • Patients with pericoronitis or local acute infection at the time of surgery.
  • • Pregnancy or lactating women.
  • • Drug allergy to tramadol and dexamethasone.

结局指标

主要结局

1) Reduction in swelling.

时间窗: postoperative 1st, 3rd and 7th day

2) Improvement in mouth opening.

时间窗: postoperative 1st, 3rd and 7th day

3) Reduction in pain.

时间窗: postoperative 1st, 3rd and 7th day

次要结局

  • 1. To compare rescue analgesia needed by the patient (duration & frequency) after submucosal injection of tramadol & dexamethasone postoperatively on 1st, 3rd & 7th day.(2. Side effects of drugs :)

研究者

发起方
chatoi socia
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

CHATOI SOCIA

MAULANA AZAD INSTITUTE OF DENTAL COLLEGE

研究点 (1)

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