Active Tactile Sensibility and Brain Activity evaluation in partially edentulous mouth with implant-supported prosthesis. An in-vivo split mouth study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Increase in tactile sensibility and brain activity
研究概览
简要总结
This is a split-mouth study focussing on evaluation of osseoperception and changes in brain activity in partially edentulous patients rehabilitated with single implant-supported prostheses. It will employ functional MRI (fMRI), Electroencephalogram (EEG), and Active Tactile Sensibility (ATS) to analyze spatial and temporal brain function and tactile sensitivity. The methodology includes psychophysical and neurophysiological assessments before and after implant placement, with periodic evaluations over time. The findings aim to explore neuroplasticity and mechanoreception, by contributing to advancements in oral neuroscience and prosthodontics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with either missing a single anterior or posterior tooth, with an intact opposing tooth of natural dentition.
- •Patients with good oral hygiene and healthy periodontal status.
- •Patients who were willing to report for follow-up visits.
- •Patients with adequate hearing ability and those who did not use or require any hearing aid.
- •No acute infection is present.
- •Informed and signed consent.
排除标准
- •Patients with history of a)Any chronic illness (any systemic disease).
- •b) Tobacco intake (smoke or smokeless) or any other substance abuse.
- •c)Temporomandibular disorders.
- •d)Any parafunctional habits like bruxism, tongue thrusting, and clenching of teeth.
- •e) Irradiation in the head and neck area.
- •Orthodontic treatment.
- •Patients with poor oral hygiene and suffering with periodontitis 5) Pregnant patients.
- •Active chemotherapy or active radiotherapy.
结局指标
主要结局
Increase in tactile sensibility and brain activity
时间窗: Before and after dental implant placement at about 3 months over a period of 2 years
次要结局
- Any changes in cognitive function(2 years)
研究者
Dr Pallavi Kendre
Institute of Medical Sciences, Banaras Hindu University