PHASE II CLINICAL TRIAL COMPARATIVE EVALUATION OF THE MODIFIED ARCH BAR AND CONVENTIONAL ERICH ARCH BAR FOR INTER-MAXILLARY FIXATION IN MANDIBULAR FRACTURES
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The modified arch bar is expected to have a better outcome in terms of:-
研究概览
简要总结
Mandible fractures are common in oral and maxillofacial surgery, often involving the body, angle, and condyle. Maxillomandibular fixation (MMF) is essential for stabilizing fractures and restoring function. Traditional MMF methods, like arch bars, have drawbacks, including tooth damage, poor oral hygiene, and discomfort. Newer alternatives, such as bone-anchored screws and orthodontic devices, offer faster application, increased comfort, and better oral hygiene with fewer complications. A prospective study will compare customized fixation devices to traditional arch bars in 30 patients, focusing on fixation stability, complications, patient satisfaction, and long-term effects, aiming to improve treatment outcomes and patient care
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Maxillomandibular trauma patient with undisplaced fracture.
- •Age group of 18–50 years.
- •Patients under the category of ASA I.
- •Patients who are willing to accept informed consent and are willing to participate in the study with subsequent follow-ups will be included in this study.
- •Patient of good periodontal health.
排除标准
- 未提供
结局指标
主要结局
The modified arch bar is expected to have a better outcome in terms of:-
时间窗: 10th day,20th day,30 th day, 37th day
• reduced time for the procedure
时间窗: 10th day,20th day,30 th day, 37th day
• better oral hygiene
时间窗: 10th day,20th day,30 th day, 37th day
• periodontal health
时间窗: 10th day,20th day,30 th day, 37th day
• and patient acceptance (post-operative pain).
时间窗: 10th day,20th day,30 th day, 37th day
次要结局
- The secondary outcome of the study is that the modified arch bar provides better intermaxillary fixation stability, preventing the risk of injuries caused by wires, and transmission of blood-born infection due to glove tear than the conventional Erich arch bar(6 MONTHS)
研究者
YOGENDRA SINGH THAKUR
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, RAIPUR