Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Amount of Pain
研究概览
简要总结
All participants in this study will be provided with information concerning the study's objectives, and benefits associated with participation. Participants will be informed that their involvement in this study presents no potential risks associated with their participation. Written consent will be obtained with appropriate information provided. Demographic data like age, BMI, gender, residence, socio economic status, occupation status, and literacy status will be documented. Patients undergoing fixed orthodontic treatment will be allocated in two groups equally by using the blocked randomization technique. Patients in Group A will undergo safe-T separators i.e initial thickness of Safe-T separators will be 1mm, Patients in Group B will undergo conventional elastomeric separators i.e thickness of elastomeric separators will be 1.2 mm. Separators will be positioned on either side of lower arch, each type of separator will be in sites, resulting in a sites within the lower arch. A separator placement tool will be utilised to position the separators. The comprehensive assessment will be carried out under the supervision of a consultant possessing at least five years of post-fellowship experience. Patient data will be recorded using a predefined structured proforma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range (18-40) Years Male/Female Patients undergoing fixed orthodontic treatment as mentioned in operational
排除标准
- •Patients with poor oral hygiene Patients with periodontal conditions Patients failed to provide consent form
研究组 & 干预措施
group A was assigned to Conventional elastomeric separators and group B to safe T separator group
Placement of conventional elastomeric separators and safe T separators intraorally in patients coming for fixed orthodontic treatment.
干预措施: Conventional Separators placement (Device)
group A was assigned to Conventional elastomeric separators and group B to safe T separator group
Placement of conventional elastomeric separators and safe T separators intraorally in patients coming for fixed orthodontic treatment.
干预措施: Safe T separator (Device)
结局指标
主要结局
Amount of Pain
时间窗: Pain will be measured over 3 days of stsrting treatment
Measuring the amount of pain caused by the two modalities of treatment using visual analogue scale
次要结局
未报告次要终点
研究者
Haris Mustafa
Dr.
Khyber College of dentistry
