Biological Variation of Iron, Total Iron Binding Capacity & Alkaline Phosphatase in Completely Edentulous Patients Rehabilitated with Conventional Complete Denture, and Implant Supported Overdenture Patients – A Clinical Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- There might be increase in serum iron, Total iron binding capicity and alkaline phosphatse in patients rehabilated with implant supported overdenture as compared to patients with conventional complete denture
研究概览
简要总结
AIM:
The aim of this clinical study is to observe the biological variation of serum iron, total iron binding capacity and alkaline phosphatase in completely edentulous patients rehabilitated with conventional complete denture and implant supported overdenture patients
Methodology:
The patients will be divided into three groups :
Group 1 - Dentate Patient (Control Group)
Group 2 - Conventional Complete Denture Patients
Group 3 - Implant Overdenture Patients
•The Modified Kuppuswamy scale will be used for determining the socio-economic status of the individuals and thereby form groups : , “upper class, upper middle class, lower middle class, upper lower and lower socio-economic class
Dentate patients with natural dentition and/or prosthetically rehabilitated dentition will be selected
•Blood samples will be drawn after taking informed consent and patients who are wiling to participate in the study and willing to get the analysis of their biochemical parameters done will be recruited , and test will be done for serum iron, TIBC and ALP and levels are recorded
•Patients will be assessed and evaluated for conventional complete denture prosthetic rehabilitation
•The patient should be completely edentulous for a span of atleast three months before his/her visit to the department
•1st Sample Collection : Blood samples will be drawn, and test will be done for serum iron, TIBC and ALP and levels are recorded prior to delivery of conventional complete denture
•Fabrication of conventional complete denture , follow up done after 24 hrs, 48hrs, 1week 15 days and 1 month
•Once patient is satisfied with the complete denture
•Usage of denture by patient for three months
•2nd Sample Collection : Blood samples will be drawn, and test will be done for serum iron, TIBC and ALP and levels are recorded after the patient has been using the denture for three months
Group 3 :
•Patients will be assessed and evaluated for implant overdenture prosthetic rehabilitation
•The patient should be completely edentulous for atleast a span of three months before his/her visit to the department
•1st Sample Collection: Blood samples will be drawn, and test will be done for serum iron, TIBC and ALP and levels are recorded prior to delivery of implant overdenture
•Preimplant phase: fabricate stent on B and D position
•Surgical phase of implant placement
•2nd stage surgery – uncovery of implant after a waiting period of three months
•Complete denture fabrication and pickup for Implant overdenture attachments
•Patient using the Implant overdenture for a period of 3 months
•2nd Sample Collection: Blood samples will be drawn, and test will be done for serum iron, TIBC and ALP and levels are recorded after the patient has been using the denture for three months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •For Dentate Patients: No missing teeth / if missing -rehabilitated with fixed prosthetics
- •Completely edentulous patients
- •No systemic diseases present 4.Adequate bone volume and quality to accommodate implants
- •Cooperative patient, willing for Implant overdenture surgical procedures, prostheticrehabilitation, and proper follow up.
排除标准
- •Patients having known history of systemic diseases
- •Patients on iron and calcium supplements
- •Patients with history of smoking
- •Patients with insufficient bone quality and quantity and vertical inter arch space to accommodate the prosthetic component.
- •Patients who are not able to maintain their oral hygiene.
- •Patients with history of drug intake like immunosuppressive drugs, anti-coagulants and anti-cancer drugs three months prior to the study.
结局指标
主要结局
There might be increase in serum iron, Total iron binding capicity and alkaline phosphatse in patients rehabilated with implant supported overdenture as compared to patients with conventional complete denture
时间窗: To evaluate and compare the biological variation of iron, total iron binding capacity& alkaline phosphatase in dentate patients, completely edentulous patients rehabilitated with conventional complete denture and mandibular implant supported overdenture patients at insertion day and follow up after 3 months
次要结局
- not applicable(not applicable)
研究者
Dr Bharath B Nandan
Manav Rachna dental College and Hospital