A Split-mouth Randomized Controlled Trial Comparing Loupes-assisted Versus Conventional Bonding of Brackets in Terms of Discomfort and Bonding Duration in Crowded Dental Arches.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient-reported discomfort
研究概览
简要总结
This study aims to evaluate whether using 3.5x dental magnification loupes improves the speed and patient comfort of the orthodontic bracket placement procedure in patients with crowded dentition, a condition that can make the process more challenging and potentially uncomfortable. We will directly compare the conventional method (unaided vision), which is employed by most orthodontists, with an alternative approach in which the clinician performs bonding while wearing magnification loupes. These loupes provide a clearer and more detailed view of the teeth during the procedure.
Both methods will be applied to the same patient using a split-mouth study design. Our primary goal is to determine which method is faster to perform and which one results in less discomfort for the patient during the appointment.
详细描述
Magnification loupes have become widely used in dental practice, demonstrating superior performance over unaided vision in many specialties such as restorative dentistry, endodontics, and periodontics, primarily by enhancing the operator's precision, ergonomics, and visual acuity. In orthodontics, loupes have also been shown to improve the quality of bracket debonding.
However, the specific role of magnification loupes in potentially modulating the patient's sensory experience immediately after the bonding procedure remains entirely unexplored. It is unknown whether the improved visualization afforded by magnification translates into a more or less comfortable patient experience during bracket placement. The presence of an advanced tool such as loupes may elevate patient expectations, potentially influencing their reported comfort.
Moreover, understanding the patient's immediate comfort is clinically meaningful, as a positive early experience may enhance overall treatment acceptance and cooperation.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 18-28 years
- •presence of all permanent teeth,
- •the presence of dental crowding,
- •sound, intact enamel surfaces on teeth to be bonded,
- •good oral hygiene, defined as a Plaque Index ≤ 1
排除标准
- •the presence of amelogenesis imperfecta, enamel hypoplasia, or white spots affecting the buccal surfaces,
- •severe or active periodontal disease,
- •congenitally missing teeth,
- •prosthetic restorations on the buccal surfaces of teeth to be bonded,
- •previous orthodontic re-treatment,
- •poor oral hygiene (Plaque Index > 1)
研究组 & 干预措施
Loupes-assisted bonding
A total of 600 brackets (120 quadrants from 60 patients) will be bonded using 3.5× magnification loupes
干预措施: Loupes-based bonding (Procedure)
Unaided-vision bonding
A total of 600 brackets (120 quadrants from 60 patients) will be bonded with the naked eye, without visual aids
干预措施: Traditional bonding (Procedure)
结局指标
主要结局
Patient-reported discomfort
时间窗: At 5 minutes after bonding the brackets.
Each quadrant will be assessed using a 100 mm Visual Analog Scale (VAS). Immediately after the bonding procedure for each quadrant, patients will be asked to mark their perceived discomfort level on a horizontal line ranging from 0 mm ("no discomfort") to 100 mm ("worst imaginable discomfort"). The exact distance from the 0 mm point to the patient's mark will be measured in millimeters, providing an accurate discomfort score for each quadrant.
Total bonding time
时间窗: This variable is going to be measured once from the beginning of the bonding procedure till the end.
Total bonding time per quadrant will be recorded using the stopwatch function of the Clock application on an iPhone, with time measured in minutes, seconds, and sub-seconds. Recording will start with the initiation of enamel etching and will conclude exactly at the completion of the final light-curing of brackets in each quadrant, representing the total operative time per quadrant.
次要结局
未报告次要终点