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临床试验/NCT06720051
NCT06720051尚未招募不适用

Efficacy of Intraosseous Versus Submucosal Dexamethasone Injection in Terms of Pain, Facial Swelling and Interincisal Opening Among Patients Undergoing Third Molar Surgery

Services Institute of Medical Sciences, Pakistan2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
76
试验地点
2
主要终点
Pain

研究概览

简要总结

The goal of this clinical trial is to learn if intraosseous dexamethasone injection is better for pain and swelling postop 3rd molar surgery than submucosal dexamethasone injection. The main questions it aims to answer are:

Does intraosseous dexamethasone injection provide better pain relief and lessen facial swelling than submucosal dexamethasone injection Does intraosseous dexamethasone injection provide better interincisal opening than submucosal dexamethasone injection Researcher will compare both the techniques to see if intraosseous dexamethasone injection works better than submucosal dexamethasone injection

Participants will:

Be assessed at 3rd and 7th day postoperatively Pain will be assessed through visual analog scale score Facial measurement will be calculated as horizontal measurement plus vertical measurement divided by 2, where horizontal measurement will be taken as the distance between corner of the mouth and the earlobe attachment, and vertical measurement will be taken as distance from outer canthus of the eye to the angle of jaw.

Interincisal opening will be measured from the incisal edge of the maxillary central incisors to the incisal edge of mandibular central incisors at the midline by using millimeter ruler

详细描述

OBJECTIVE: To determine the efficacy of intraosseous versus submucosal dexamethasone injection in terms of pain, facial swelling and interincisal opening among patients undergoing mandibular 3rd molar surgery OPERATIONAL DEFINITIONS

Mandibular third molar:

A mandibular third molar prevented from erupting into position because of malposition or lack of space will be assessed on clinical (visual examination in oral cavity) and radiographical examination (periapical and/or orthopantomogram) by using Pell and Gregory classification method and modified Winter's classification method

Efficacy:

Efficacy of intraosseous and submucosal dexamethasone will be assessed in terms of lower VAS pain score, less facial swelling, and greater interincisal distance.

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 (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing mandibular third molar surgery
  • Age 18 to 35 years
  • Male and female

排除标准

  • Uncontrolled systemic medical problems including diabetes and hypertension
  • Presence of any cyst, tumor, or other pathological condition in the molar area
  • Presence of any craniofacial anomalies, congenital deformities or syndromes
  • Patients with known adverse effects of steroid use
  • Previous history of orthodontic treatment
  • Have a pain disorder or taking pain medications
  • Pregnant and lactating mothers

结局指标

主要结局

Pain

时间窗: 3rd and 7th day post operatively

Pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage. Pain will be assessed using visual analogue scale (VAS), which is a self-administered continuous scale comprised of a line of 10 cm in length, anchored by "no pain (score 0)" and "pain as bad as it could be (score 10)". The patient is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity; and score is determined by measuring the distance between "no pain (score 0)" anchor and the patient's mark. A higher score indicates greater pain intensity

Interincisal opening

时间窗: 3rd and 7th day post operatively

Interincisal opening will be measured from the incisal edge of the maxillary central incisors to the incisal edge of mandibular central incisors at the midline by using millimeter ruler

Facial swelling

时间窗: 3rd and 7th day post operatively

Facial swelling is the buildup of fluid in the tissues of the face. Facial measurement will be calculated as horizontal measurement plus vertical measurement divided by 2, where horizontal measurement will be taken as the distance between corner of the mouth and the earlobe attachment, and vertical measurement will be taken as distance from outer canthus of the eye to the angle of jaw

次要结局

未报告次要终点

研究者

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mahreen Mahmood

OMFS Resident

Services Institute of Medical Sciences, Pakistan

研究点 (2)

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