Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket? A Comparative Study of Two Bracket Systems and Two Debonding Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain on adhesive removal
研究概览
简要总结
The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.
详细描述
100 consecutive patients who completed treatment with one of two bracket systems (2-slot brackets with integral base or conventional twin brackets with foil mesh) were included in this prospective clinical trial. Prior to the removal of brackets, participants were asked to evaluate the level of pain encountered throughout their orthodontic treatment with the fixed appliances, utilizing a 0-10 numerical rating scale, and to indicate the main cause of pain. Subsequently, brackets on the right side of both dental arches were debonded using the lift-off debonding instrument (LODI), while on the left side, the bracket removal pliers (BRP). The residual adhesive was removed through two methods (manual in the upper arch and rotary in the lower). The same scale was employed to assess pain levels during brackets and adhesive removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fixed appliance in both dental arches
- •brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions
排除标准
- •periodontal disease
- •restorations or caries on buccal surfaces of the teeth,
- •consumption of analgesics within eight hours preceding the debonding appointment
研究组 & 干预措施
2-slot brackets
50 patients treated with 2-slot brackets.
干预措施: bracket removal pliers, LODI (Device)
Twin brackets
50 patients treated with traditional twin brackets.
干预措施: bracket removal pliers, LODI (Device)
结局指标
主要结局
Pain on adhesive removal
时间窗: On the day of debondig (after adhesive removal in each quadrant).
Numerical Rating Scale (0-10) was used to assess pain during adhesive removal.
Pain during active treatment
时间窗: On the day of debondig (at the end of active treatment).
Numerical Rating Scale (0-10) was used to assess pain level during active treatment.
Pain during brackets removal
时间窗: On the day of debondig (after debonding of each single bracket).
Numerical Rating Scale (0-10) was used to assess pain during brackets debonding.
次要结局
未报告次要终点
研究者
Piotr Fudalej
Prof. dr hab.
Jagiellonian University