Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar: A Prospective Split-mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?
研究概览
简要总结
Patients with jaw fractures requires placement of Erich arch bar for immobilization of the fractured jaw. However, the usage of Erich arch bar is associated with an increased in the incidence of mucosal trauma and plaque accumulation. Conventionally, the ends of the wires has always been placed apical to the teeth.
This study aims to determine if a change in the placement of the wire by directing it to the occlusal direction will reduce the incidence of mucosal trauma, plaque accumulation and if the stability of the Erich arch bar will be affected by this intervention.
The patients' teeth will be divided into left and right side and randomized into control side (wires end apically) and interventional side (wires end occlusally)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants are blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years - 60 years old.
- •Full Glasgow coma scale.
- •Facial fractures requiring Erich arch bar for 4 weeks duration
- •No functional deficit that will prevent tooth brushing.
排除标准
- •All pathologic fractures due to cysts, tumors, and cancers
- •Medical conditions that contraindicate the usage of arch bars (Epilepsy, Asthmatics)
研究组 & 干预措施
Apical ending of wires
The wires will be bent apically for the control side.
Occlusal ending of wires
The wires will be bent occlusally for the interventional side
干预措施: Ending of the wires on Erich arch bar in the occlusal direction (Device)
结局指标
主要结局
Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?
时间窗: Assessed on the fourth week
Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'.
Are there any differences between occlusally and apically bent groups in terms of mucosal trauma?
时间窗: Assessed on the second week
Any mucosal injuries (Indentations, Entrapment, ulcerations) during follow up will be recorded as scored as '1'.
次要结局
- Are there any differences between occlusally and apically bent groups in terms of Turesky-Gilmore-Glickman plaque score?(Assessed on the fourth week.)
- Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?(Assessed on the fourth week)
- Are there any differences between occlusally and apically bent groups in terms of stability of the arch bar?(Assessed on the second week)
研究者
Ng Kar Tsyeng
Principal investigator
Universiti Sains Malaysia