Correlation of neuroplastic activity and masticatory force in All-on-four and All-on-six implant supported prosthesis wearers - An in-vivo study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in the cortical activity in functional magnetic resonance imaging is done
研究概览
简要总结
A total of 10 patients will be selected from the Out Patient Department (OPD) of Prosthodontic unit of Faculty of Dental Sciences, Institute of Medical Sciences, BHU. Patient selection will be made according to inclusion and exclusion criterion. After taking history, patient will be evaluated clinically and radiographically. The proposed treatment plan will be explained to the patient and necessary investigation will be done after consent has been taken.
In group 1 patient (5 each), All-on -four implant treatment plan will be proposed , at first conventional denture will be proposed. At first conventional denture will be made then after 1 month functional MRI will be taken to see the brain activity followed by assessing the masticatory force. After that four implant will be placed each in maxillary and mandibular arch followed by waiting for 3 month to osseointegrate. Prosthetic rehabilitation will be done after 3 month followed by again taking the functional MRI to see the cortical changes and assessment of masticatory force.
In group 2 patient (5 each), All on six implant treatment plan will proposed. Similar to group 1 at first we will rehab with conventional denture then implant treatment, 6 implant in each arch. Then followed by functional MRI and masticatory force assessment .Thus, we can make intragroup as well as intergroup assessment that is between all on four and all on six treatment.
Functional MRI:It is a non-invasive method to assess sensory function and visualisation of brain activities through MRI. will be carried out in the Radiodiagnosis Department of Sir Sunderlal Hospital, IMS,BHU. Subjects will be asked to clench during the procedure while using their respective complete denture prosthesis/implant supported prosthesis during clenching activity. Subsequent to data collection ,a sensitivity frequency(Fd%) will be applied, and the data thus obtained will be subjected to statistical analysis.
Necessary changes may be made in the methodology of proposed study, in its best interest
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Completely edentulous arch or non-restorable remaining teeth.
- •2.Patient’s cooperation, motivation and good oral hygiene.
- •3.No acute infection should be present.
- •4.Without any history of temporomandibular joint disorders, pscychiatric disorders or on neuromodifying medication.
- •5.Signed informed consent.
排除标准
- •1.Use of medical devices or the presence of conditions that would be dangerous in or incompatible with the MRI environment.
- •2.Use of over-the-counter medications within 3 days of the imaging session; presence of systemic, vascular, or central nervous system diseases.
- •3.Use of medications with known neuromotor effects, e.g., neuroleptics or antidepressants.
- •4.Unnecessary habits (smoking, presence of parafunctional habits) 5.Insufficient mouth opening to accommodate surgical instruments 6.Traumatic occlusion.
- •7.Non –compensated diabetes mellitus.
结局指标
主要结局
Change in the cortical activity in functional magnetic resonance imaging is done
时间窗: At 1 month then at 4 month
次要结局
- Increase in the masticatory force following prothetic rehabilitation after 1 months then after 4 months(1 month then after 4 months)
研究者
Stanzin Yangdol
Faculty of dental sciences IMS BHU Varanasi