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临床试验/NCT07119814
NCT07119814尚未招募不适用

Comparison of Outcome of Safe T Separators and Conventional Elastomeric Separators

Khyber College of dentistry1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

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

Other

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

Other

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

发起方
Khyber College of dentistry
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haris Mustafa

Dr.

Khyber College of dentistry

研究点 (1)

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