Clinical Outcomes of Implant- Versus Abutment-level Connection in Screw-retained Fixed Dental Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Marginal bone resorption in millimeter from the implant to the bone crest.
研究概览
简要总结
The aim of this study is to evaluate:
Primary objective The primary objective of the present study is to evaluate the marginal bone level changes when partially edentulous patients, treated with implants, received a multiunits screw retained fixed dental prosthesis with a Co/Cr milled framework with an Internal or External connection.
Secondary objective
- Overall survival rate.
- Soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and after 1,3,5 years.
- Prosthetic survival rates including screw or abutment loosening, framework or veneer fractures.
详细描述
A randomized pilot study is designed to determine marginal bone changes between patients treated with a milled framework in Co/Cr if the connection is Internal or External for the rehabilitation of a partially edentulous area with a multiunit screw retained bridge. The investigation will be performed in one clinical centre affiliated to the Department of oral and maxillofacial surgery, Faculty of Odontology, Malmö University . In this center the clinician and the examiner will be the same person.
Following a screening examination, subjects who will meet the inclusion criteria, will sign the Informed Consent and will be enrolled in the study. The period of patient enrollment will begin on October 1st 2015 and ends September 31st 2016.
The patients will be randomized with a method based on the use of sealed opaque envelopes. The cases will be assigned to two different treatment groups:
Group A- Co/Cr milled framework with internal connection (Test) Group B- Co/Cr milled framework with external connection (Control)
-Pre-treatment Patient data, medical history, clinical and radiographic examination will be recorded for each patient. Clinical photographs will be taken in frontal, occlusal and lateral projections Periodontal, endodontic and open caries lesions will be treated prior to implant installation. All patients will receive careful oral hygiene instructions and training in self-performed plaque control measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years.
- •Willingness to comply with all study requirements and to sign the IC.
- •Systemic health.
- •Compliance with good oral hygiene.
- •Patients with at least 2 teeth to replace in any side of the jaws.
排除标准
- •Patients treated with implant with bone defects associated with severe knife-edge ridges.
- •Patients treated with bone defects resulting from tumor resection.
- •Tobacco abuse (> 10 cigarettes/day).
- •Severe renal and liver disease.
- •History of radiotherapy in the head and neck region.
- •Chemotherapy for treatment of malignant tumors at the time of the surgical procedure.
- •Uncontrolled diabetes.
- •Active periodontal disease involving the residual opposite dentition.
- •Mucosal disease, such as lichen planus, in the areas to be treated.
- •Poor oral hygiene.
- •Non-compliant patients.
- •Situations judged inconvenient(by the investigator) for the surgical treatment.
研究组 & 干预措施
Test: internal connection
Evaluate marginal bone level (MBL) changes at implants that are placed semi-edentulous patient when they are treated with implant level Co/cr Cad/Cam framework.
干预措施: Internal vs. external cad cam co/cr framework (Device)
Test: external connection
Evaluate marginal bone level (MBL) changes at implants that are placed semi-edentulous patient when they are treated with abutment level Co/cr Cad/Cam framework.
干预措施: Internal vs. external cad cam co/cr framework (Device)
结局指标
主要结局
Marginal bone resorption in millimeter from the implant to the bone crest.
时间窗: 5 year
Marginal bone resorption in millimeter from the implant to the bone crest.
时间窗: 1 year
Marginal bone resorption in millimeter from the implant to the bone crest.
时间窗: 3 year
次要结局
- Fracture of the prosthetic components(5 year)
- Fracture of the prosthetic components(1 year)
- Fracture of the prosthetic components(3 year)
研究者
Toia Marco
dr
Malmö University