Intra-oral Evaluation of Force Decay of Pigmented and Transparent Elastomeric Power Chains: A Randomized Clinical Trail.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Evaluate the force decay of pigmented and transparent elastomeric power chains in a group of orthodontic patients
研究概览
简要总结
This study aimed to evaluate the amount of force decay in pigmented and transparent elastomeric power chains. The principal investigator measured the amount of force decay at 7 intervals using a calibrated Dentaurum force gauge. This study also assessed the associated variables that accelerate the force loss, such as brushing frequency, beverage consumption,mastication, Khat chewing, oral , and tooth movement, . The study outcomes provide evidence-based guidance for selecting elastomeric power chains in routine orthodontic practice.
详细描述
The study was a split-mouth randomized clinical trial. Four colors (pink, blue, black, and grey) and transparent elastomeric power chains from 3 different companies (American Orthodontic, SIA, and Matt) were evaluated. A total of 96 participants were recruited, and 192 elastomeric power chains were stretched between the canine bracket hook and the molar band hook throughout the study period. The delivered force of elastomeric power chains was assessed and compared among each other using a calibrated Dentarum force gauge over 6-week intervals (baseline, 24 hours, first week, second week, third week, fourth week, fifth week, and sixth week). To further investigate factors influencing force decay (FD), data on tooth movement, mastication side, beverage consumption, brushing frequency, oral hygiene status, and khat chewing were collected using a structured questionnaire to assess their potential impact.
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
- Double (Participant, Investigator)
盲法说明
Masking Description
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 12-30 years.
- •Patients who are undergoing fixed orthodontic treatment.
- •Orthodontic patients who underwent bilateral extraction protocol in maxillary arch.
- •Patients were in working arch wire 19×25 stainless steel.
- •Patients with moderate anchorage to ensure comparable baseline mechanics.
排除标准
- •Patients indicated for orthognathic treatment.
- •Patients who reported any systemic diseases.
- •Patients with clefts or syndromes.
结局指标
主要结局
Evaluate the force decay of pigmented and transparent elastomeric power chains in a group of orthodontic patients
时间窗: Baseline and weekly for 6 weeks.
Measurement of the amount of force decay (in grams) for each elastomeric power chain sample at baseline and at 7 time intervals over 6 weeks using a digital force gauge.
Evaluate the force decay of pigmented and transparent elastomeric power chains in a group of orthodontic patients
时间窗: Baseline and weekly for 6 weeks.
Measurement of the amount of force decay (in grams) for each elastomeric power chain sample at baseline and at 7 time intervals over 6 weeks using a digital force gauge.
次要结局
- Correlation between force decay and associated variables (tooth movement, masticating side, beverage consumption, brushing frequency, oral hygiene, and khat chewing)(At 6 weeks)
- Correlation between force decay and associated variables (tooth movement, masticating side, beverage consumption, brushing frequency, oral hygiene, and khat chewing)(At 6 weeks)
研究者
Maha Saleh Mahdi Al-Muntaser
Principal Investigator
Sana'a University