跳至主要内容
临床试验/NCT06156111
NCT06156111进行中(未招募)不适用

Bacterial Microleakage and Bone Loss in Internal Connection Dental Implants Based on the Type of Abutment Used in Zirconia Partial Fixed Prosthesis: in Vivo Study

Universidad Complutense de Madrid2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Bacterial micro-filtration: Bacterial load analysis

研究概览

简要总结

This clinical trial aims to observe if there are differences in bacterial micro-filtration on interfaces and to evaluate if there are differences in the occurrence of peri-implant diseases and bone loss in fixed partial monolithic zirconia CAD/CAM implantsupported prostheses with and without abutment in patients at the Advanced Implant Prosthetics Clinic of the Complutense University of Madrid, of both sexes, over 18 years of age, whose treatment plan is based on the replacement of dental pieces with two fixed partial dentures on implants, in such a way that the study will be performed "split mouth" rehabilitating one of them with zirconia bridges on attachments with connection and others with Zirconia bridges with flat attachments or without connection. The main question it aims to answer is whether the not use of abutment influence bacterial micro-leakage and the development of peri-implant diseases and bone loss at that level in fixed partial monolithic zirconia CAD/CAM prothesis.

Participants will:

  • Receive two fixed partial monolithic zirconia CAD/CAM prothesis, one will be attached to an abutment (control group) and the other not (test group)
  • Subsequently, control appointments of the fixed implant supported prosthesis treatment will be performed (1, 3,6, 12 and 24 months) and radiographies will be made with the parallelizing device attached by the silicone key.

Researchers will compare fixed partial monolithic zirconia CAD/CAM implant-supported prostheses with and without abutment to see:

  • Differences in bacterial micro-leakage on interfaces.
  • Occurrence of peri-implant diseases and bone loss

详细描述

BACKGROUND

Since the discovery of osseointegration by Branemark, dental implant treatment has been growing in importance for the replacement of missing teeth until it has become the treatment of choice in most cases of partial and total tooth absences. Although in the beginning, implants were used to hold mandibular prostheses, they had a smooth surface, and the connection they presented on their platform was an external hexagon. These characteristics were established empirically in the absence of previous experience. Currently, implants are one of the most widely used dental treatments and have evolved both in their indications and in their design. Regarding their indications, they are used for the treatment of all types of edentulism, from a unitary implant to the rehabilitation of a complete arch. On the other hand, in terms of design, the modifications and variables are so numerous that it is impossible to list them all, but fundamentally, it has progressed on the surface, macroscopically and microscopically, achieving a greater proportion of tooth-implant union, and in the connection, moving from the initial external hexagon to internal connections with different designs: hexagonal, octagonal, morse cone, and hexagon, with the aim of preventing the complications that can appear in this type of prosthesis, both mechanical (the most frequent being loosening of the screw) and biological (mainly bacterial microfiltration).

The mismatch at the level of the junction between implant-abutment or implant-prosthesis in the case of a prosthesis directly screwed to the implant(s) has been and is one of the workhorses in implantology due to the influence it has on bacterial microfiltration, and this is demonstrated by the large number of studies that exist on this subject. In an ideal situation, this mismatch should not exist and should be cero, so that the bacteria existing in the oral microflora could not filter and accumulate in that implant attachment or implant prosthesis junction. In reality, it is impossible to achieve that perfection goal even in the manufacture of prefabricated machined parts and for unit implants, since a dimensional margin is necessary to allow their correct settlement, especially when connected directly to the implant (without the intermediation of a prefabricated abutment) by individualized manufacturing processes. That is why, from this point of view, it would be advisable to use prefabricated abutments in all cases of partial prostheses in order to keep the possible misalignment of the prosthesis away from the implant-attachment joint. This mismatch, however, must be understood not only as evaluated by different studies as a linear discrepancy but also from a three-dimensional point of view, since once it is accepted that the perfect fit does not exist, microfiltration will occur to a greater or lesser extent depending on the design of the connection; for example, it will not be the same in an external hexagonal connection as in an internal octagonal one.

The importance of bacterial microfiltration at the level of the implant-abutment junction from a clinical point of view is of special relevance since the accumulation of bacteria at that level, in most cases subgingival, could be directly related to the colonization of anaerobic bacteria, more aggressive, in locations that are difficult to access for sanitization by the patient. in such a way that they could favor the beginning of pathological bone destruction and the development of a peri-implant disease, complications of relative frequency, and that can be defined as infectious processes that occur in the tissues around the implants. When the inflammation around the implants presents with bone loss, bleeding, and/or suppuration on probing, it is considered peri-implantitis. It is a complication that is complicated and difficult to treat since the surface of the implant is contaminated and non-surgical treatments are usually insufficient to clean it, while surgical treatments are not only more aggressive but are also not inflatable and can also lead to aesthetic complications due to retraction of the soft tissues and even the exposure of the implant itself (metallic in most cases).

On the other hand, as for the implant prosthesis itself, its evolution since its origins with respect to its design and materials has also been very important. Among the materials used today to make fixed prostheses on implants, one of the most important is zirconia. Its use has become widespread because it has qualities that improve the materials considered until recently the gold standard, which were made with a metal structure (Titanium, Cr-Co, Cr-Ni, Cr-Ni, Cr-Ni-Pa, Pa-Co, etc.) and the aesthetic coating of porcelain, added by a brushstroke process carried out by a laboratory technician and then fired in processing ovens. Among the advantages of zirconia are: its CAD/CAM (Computer Aided Design/Computer Aided Manufacturing) manufacturing, i.e., computer design and manufacturing by milling process (as it can be milled in a softer, pre-synthesized phase, improves metal milling, makes it cheaper, and involves much less wear); its biocompatibility; and its aesthetics, as it is a white material. This quality allows the creation of prostheses without the need for aesthetic coating, known as monolithic zirconium. This modality, monolithic zirconium, is one of the most used treatment alternatives in fixed prostheses on implants because it also manages to solve one of the most frequent mechanical complications in fixed prostheses on implants, which is the porcelain jump or chipping. The term "chipping" is defined as "the detachment of one material attached to another when subjected to a load, separating the two".

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
Double (Participant, Investigator)

盲法说明

The assessment and the measurements will be performed by a separate person, not the operator. The patient will not know in which quadrant the abutments will be placed or not.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients susceptible to treatment with implants.
  • Being over 18 years old.
  • Not being severe smokers (>20 cigarettes/day)
  • Not having diseases that can affect bone metabolism, such as arthritis and osteoporosis, and not having uncontrolled systemic diseases.

排除标准

  • Any contraindications for oral surgical procedures.
  • Conditions or circumstances that, in the opinion of the investigator, would preclude completion of participation in the study or interfere with the analysis of the study results.

结局指标

主要结局

Bacterial micro-filtration: Bacterial load analysis

时间窗: 2 years

Samples will be obtained at the conection of the study control and study test from each patient. Samples will be taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 30 s and then transferred into a screw-capped vial. Samples will be transported to the microbiology laboratory within 2 h and stored in deep freezing (-80ºC). Samples will be processed for multiplex RTPCR for detection of total anaerobic counts and counts of selected periodontal pathogens Data will be expressed in colony-forming units (CFU) per mL of the original sample.

Bone level change

时间窗: 2 years

On the standardized peri-apical radiographs implant bone levels will be evaluated. The reference point for the bone level measurement will be the implant shoulder. The bone level will be measured as the distance between the implant shoulder and the first visible bone contact on the implant. Mean bone level changes between two time-points will be computed by subtracting the average bone level from one visit with the other.

Peri-implant pathologies development

时间窗: 2 years

The peri-implant pathologies development will be evaluated through the presence of unhealthy clinical records on probing pocket depth and bleeding on probing.

次要结局

  • Inter-proximal contact point(2 years)
  • Bleeding on Probing (BoP)(2 years)
  • Probing pocket depth (PPD)(2 years)
  • Volumetric variation of peri-implant soft tissues(2 years)
  • Prosthetic mechanical behavior(2 years)
  • Patient satisfaction(2 years)
  • Protheses material wear(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel Gómez Polo

Associate Professor of Conservative Dentistry and Prosthodontics

Universidad Complutense de Madrid

研究点 (2)

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