The Marginal Bone Loss in Implants of External Connection Versus Internal Connection and Submerged Implants Versus Non-submerged Implants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- A COMPARISON BETWEEN THE DIFFERENT CONNECTIONS AND POSITIONING OF THE IMPLANTS REGARDING THE BONE OF LOSS
研究概览
简要总结
When an implant is placed, it is assumed that there will be a loss of bone in the more coronal area around it. The placement of the implant in relation to bone level, either crestal or subcrestal and the type of connection chosen, either external connection or internal connection, have been related as one of the factors that caused this loss. The preservation of the peri-implant bone influences the shape and contour of the underlying soft tissues, which are important for the aesthetic result of the treatment and for the success of the same.
Hypothesis: The hypothesis is that there are no differences between the external and internal connection with regard to marginal bone loss. In implants placed at the crestal and subcrestal level, the hypothesis is that there is greater marginal bone loss in implants placed at the subcrestal level.
Objectives: Main: To evaluate the marginal bone loss around implants of internal connection and external connection. Secondary: To compare the loss of bone in implants of internal connection placed at crestal and subcrestal level. To evaluate intra and post-operative complications.
Material and methods: A prospective and randomized radiological study will be performed. 150 implants will be placed in patients who must present partial edentulism and require the replacement of at least 2 crowns on implants in the same jaw. In a randomized manner, implants of external connection and internal connection will be placed. Other features such as surface treatment type of the implant will be similar in both types of implants to reduce bias.
With this study the investigators will try to define if there is a procedure in when to the connection of the implant and the location of this, that is more beneficial with respect to the preservation of bone.
详细描述
Implant dentistry has undergone major development and expansion since the nineteen sixties, when Dr. Branemark (Sweden) introduced the concept of osseointegration. The use of implants to replace missing teeth and restore function has presented a high success rate and long-term survival. For this reason rehabilitation by means of implants has become standard and well accepted by patients, who increasingly demand treatments offering greater comfort and aesthetics. Implant-based treatments must fulfill a range of physiological, functional and aesthetic criteria before they can be considered successful. These include osseointegration stability and duration, absence of pathological processes, and aesthetics that satisfy the patient.
There are diverse types of implants and corresponding systems that connect the implant to the prosthesis. Implant connections fall into two main groups: External and Internal Connection.
When an implant is placed, it is estimated that there will be bone loss around this during the first year, both horizontally and vertically. Actually is considered successful if the loss of crestal bone around the implant is less than 1.5mm during the first year and less than 0.2 annually in the next. This bone loss continues to occur despite the new designs of implants that try to stop it. The preservation of the peri-implant bone is an important factor for the success of the same. The quantity and quality influence the shape and contour of the overlying soft tissues, which are important for the aesthetic result of the treatment. The hypothesis is that there are no differences between the external and internal connection with regard to marginal bone loss. In implants placed at the crestal and subcrestal level, the hypothesis is that more marginal bone is loss in implants placed at the subcrestal level design.
A prospective randomized controlled, split-mouth clinical trial with a sample size of 50 implants per arm is proposed.
Population of the study Patients attended in HOUB (Hospital Odontológico Universitario de Bellvitge. Master of Medicine Surgery and Implantology and Master of Dentistry in Oncology and Immunocompromised Patients).
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)
盲法说明
Blind study The RX examiner and the person performing the resonance frequency measurements would be independent of the surgeons who placed the implants.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of general age who present partial edentulism in the mandible and / or maxilla and require the replacement of at least 2 teeth by implants in the same maxilla.
- •The teeth must have been removed at least 4-6 months before implant placement.
- •The minimum required bone height would be 6mm, which would be determined by an orthopantomography (1: 1)
排除标准
- •History of use of bisphosphonates
- •Evidence of serious systemic diseases such as recent infarction
- •Uncontrolled diabetes, coagulation disorders, cancer, psychiatric contraindications,
- •Active infection in the area of the implants
- •Absence of an antagonist in the area of implant placement
- •Pharmacological treatments capable of affecting gingival health
- •Pregnant or lactating women.
研究组 & 干预措施
External-Connection non-submerged Imp
We will place implants with external connection and non- submerged to assess the bone loss around
干预措施: External-Connection non-submerged Imp (Device)
Internal Connection Submerged implants
We will place implants with internal connection and submerged to assess the bone loss around
干预措施: Internal Connection Submerged implants (Device)
Internal Connection non-Submerged Impl
We will place Internal connection implant and non-Submerged Implants to assess the bone loss around
干预措施: Internal Connection non-Submerged Impl (Device)
结局指标
主要结局
A COMPARISON BETWEEN THE DIFFERENT CONNECTIONS AND POSITIONING OF THE IMPLANTS REGARDING THE BONE OF LOSS
时间窗: 1,4 years around
By means of measurements in millimeters in the radiographs, the loss of bone will be compared. These measurements will be made one month after the placement of the implant, at 3-4 months in the placement of the crown, 6 months after placement of the crown and one year after placement of the crown
次要结局
未报告次要终点
研究者
Natalia Palacios Garzón
PhD student (Universitat de Barcelona)
University of Barcelona