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临床试验/CTRI/2024/05/067285
CTRI/2024/05/067285尚未招募4 期

Efficacy of submucosal and massetric methylprednisolone prior to impacted third molar surgery- A randomized controlled trial

Priyanka Gajare1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年5月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
Reduction in pain, swelling, trismus and evaluation of post operative complications and quality of life

研究概览

简要总结

EFFICACY OF SUBMUCOSAL AND MASSETRIC METHYLPREDNISOLONE PRIOR TO IMPACTED THIRD MOLAR SURGERY- A RANDOMIZED CONTROLLED TRIAL.

 William stated impacted tooth as one which is completely or partially unerupted and is positioned against another tooth, bone, or soft tissue so that its further eruption is unlikely.

Pain, edema, trismus and inflammation followed by tissue injury are common postsurgical complications. Corticosteroids, like methylprednisolone, dexamethasone, or betamethasone, are potent inhibitors of inflammation because of their suppressive impact on the synthesis and release of inflammatory tissue mediators.

The main objective of this study is to investigate the effect of methylprednisolone injection on the reduction of postsurgical complications like Pain and Trismus. We aim at comparing the efficacy of submucosal and massetric Methylprednisolone prior to impacted third molar surgery.

Patients with Moderate Difficulty index of impacted mandibular third molar as per Pederson Difficulty Index between age of 21 to 40 years will be included in the study. Patients will be divided into Group A and B following randomisation. In one group submucosal methylprednisolone and in another group massetric methylprednisolone will be administered prior to surgical removal of mandibular third molar. Post operative complications like pain, trismus, swelling, and quality of life of the patients will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Patients who are willing to participate in the study.
  • Healthy subjects (ASA Grade I and Grade II patients).
  • Patients in the age group of 21-40 years.
  • Patients with no contraindications to the drugs or anaesthetic used in the surgical protocol.
  • Patients with Moderate Difficulty index of impacted mandibular third molar as per Pederson Difficulty Index.

排除标准

  • Patients not giving consent for participation in the study.
  • Immunocompromised patients.
  • Patients who are contraindicated to corticosteroids.
  • Diabetic patients
  • Pregnant or lactating patients.
  • Mentally challenged patients, those with severe systemic conditions, bone infections, osteomyelitis or osteoradionecrosis of jaw, any malignancy, cyst or tumor associated with the third molar.

结局指标

主要结局

Reduction in pain, swelling, trismus and evaluation of post operative complications and quality of life

时间窗: 1 day, 4 days, 1 week, 2 weeks

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Priyanka Gajare
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Priyanka Gajare

Government Dental College and Hospital Mumbai

研究点 (1)

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