跳至主要内容
临床试验/NCT01229995
NCT01229995Unknown不适用

A Comparison of Zirconia CAD/CAM and Conventionally Fabricated Single Implant Abutments and Restorations in the Esthetic Zone: a Randomized Controlled Clinical Trial.

Harvard School of Dental Medicine0 个研究点目标入组 30 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
The aim of this randomized controlled clinical trial is to examine single-tooth implant abutments and restorations in the esthetic zone.

研究概览

简要总结

CAD/CAM technology has been introduced to the field of implant dentistry in the beginning of 1990's (Priest 2005). Since their introduction, the use of CAD/CAM technology in the production of dental implant restorations has been rapidly expanding. However, little evidence is currently present supporting its clinical viability (Henriksson 2003, Canullo 2007).

Therefore, the suggested prospective randomized study includes bone level placed Straumann implants restored with transmucosal elements and crowns fabricated using either CAD/CAM "Etkon" technology (Zirconia abutment and ceramic crown) or a conventional technique (Crossfit titanium abutment and a ceramometal crown).

The aim of this randomized controlled clinical trial is to examine single-tooth implant restorations in the esthetic zone. An esthetic area is defined as any area that is visible in the patient's full smile. [3rd ITI consensus conference 2004] The rehabilitations will be fabricated using two different techniques. Zirconia CAD/CAM (ZCC) implant restorations (tests) will be compared to Titanium conventionally-fabricated (TCF) implant restorations (controls) using, reproducible esthetic (objective/subjective) and biologic parameters.

This in vivo study is a randomized study with two groups of 15 patients with one implant each for a total of 30 patients and 30 implants. The implants will be examined for successful tissue integration according to the criteria of success (Buser et al. 1990) at every recall visit.

In addition, the following parameters will be evaluated for each restoration:

  • Esthetic: A. Objective: PES/WES Score (Belser et al. 2009) from 1:1 digital photograph, study casts, and spectrophotometric measurements, and B. Subjective: VAS questionnaire for patients and VAS questionnaire from experts.
  • Biologic (mPI, mB, simplified GI, microbial sample, periapical radiograph for DIB, and width of keratinized facial mucosa)

Finally, an evaluation of the mechanical, biologic and technical complications will be performed at every recall visit. Mechanical complications would be defined as those complications that involve the prosthesis such as abutment screw loosening, fracture of the veneer material, fracture of the crown framework, abutment screw fractures, and implant fractures. The category of biologic complications will include those complications that involve the soft tissues (e.g., fistula, suppuration, bleeding, gingival inflammation, and soft tissue dehiscence). Technical complications are defined as those related to restorative components and crowns (e.g. crown emergence profile, abutment and crown fit, screw loosening, ceramic fracture).

详细描述

Introduction

Long-term prospective studies demonstrate a high success rate of Straumann implants in partially or fully edentulous patients both with early and conventional loading (Salvi et al. 2004, Lambrecht et al. 2003, Cochran et al. 2002, Weber et al. 2000, Buser et al. 1997). Before the introduction of CAD/CAM technology to the field of implant dentistry in the beginning of 1990's (Priest 2005), the available approach for restoring single dental implants was either with stock or cast custom abutments and a ceramo-metal crowns. In spite of the satisfactory results that this conventional treatment approach has achieved, several disadvantages have been recognized. First, non tooth-colored abutments possess the problem of bluish appearance of overlying tissue in cases of thin gingival biotype (Barclay et al. 1996, Prestipino and Ingber, 1996). Second, with stock abutments ideal emergence profile can not be achieved (Daftary 1997), a disadvantage that was reduced with the use of custom abutments. However, custom abutments present other disadvantages including possible imprecision of fit due to inaccuracies associated with impression, waxing, investing and casting procedures and the negative effect of the gold alloy on the peri-implant mucosal barrier as demonstrated by Abrahamsson in 1998 (Abrahamsson et al 1998 ).

The introduction of CAD/CAM technology to implant dentistry was meant to provide higher quality restorations. Since its introduction, the use of this technology in the production of implant ceramic frameworks and crowns especially in esthetic regions has been rapidly expanding because of the promising esthetic, biologic, and mechanical properties. Alumina as well as Zirconia abutments are characterized by good tissue compatibility (Abrahamsson et al. 1998). In a study by Barclay et al in 1996 it was found that plaque accumulation scores for ceramic-coated transmucosal elements were significantly lower than those recorded in titanium transmucosal elements (Barclay et al. 1996). These results suggest that the further development of a ceramic implant transmucosal collar may assist plaque control at the soft tissue-implant interface and may favorably influence the tissues in this region (Barclay et al. 1996). Other studies documented no significant differences in plaque accumulation and microbial colonization between titanium and ceramic abutment samples (Andersson et al. 2003, Rasperini et al. 1998). The bacterial colonization of Zirconia ceramic surfaces was recently studied in vitro and in vivo (Rimondini et al. 2002). The authors found that, overall, Zirconia ceramic surfaces developed for implant abutments accumulate fewer bacteria than commercially pure titanium, and may therefore be considered as a promising material for abutment manufacturing (Rimondini et al. 2002). A comparison of the recorded superficial soft tissue responses to titanium and ceramic surfaces of transmucosal elements of implants revealed no significant differences between both groups (Barclay et al. 1996, Andersson et al. 2001). Almost no marginal bone loss was recorded, indicating a stable bone situation both at ceramic and titatium abutments on single-tooth implants (Andersson et al. 2001). However, it seems to be that the peri-implant soft tissues adjacent to titanium and ceramic surfaces may differ in features that are not apparent when routine clinical parameters are used (Barclay et al. 1996).

Because of their specific mechanical properties, all-ceramic restorations demonstrate a lower fracture resistance than ceramic restorations supported by metal substructures. The ceramic abutments on implants are more sensitive to fracture and to handling procedures than the titanium abutments (Andersson et al. 2001). However, advances have been made in the fabrication of high-strength all-ceramic abutments for anterior implants (Yildirim et al. 2003). The hardness of the Zirconium ceramic also allows it to undergo conventional prophylaxis with ultrasonic scalers without alteration of its surface quality of abutment (Marzouk, 1996). Moreover, Zirconia has a flexural strength and fracture toughness almost twice as high as alumina (Glauser et al. 2004, Yildirim et al. 2003).

Currently very limited number of clinical studies is present supporting the clinical viability of CAD/CAM ceramic restorations (Henriksson 2003, Canullo 2007) and no reports were found on the performance of CAD/CAM ceramic implant restorations in comparison to conventional implant restorations.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

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

入选标准

  • Inclusion Criteria:
  • Age > 21 years
  • Absence of relevant medical conditions
  • Absence of periodontal diseases
  • The opposing dentition must be natural teeth or fixed (not removable) restorations on teeth or implants.
  • Availability for 5-year follow-up
  • One missing tooth in the esthetic zone. An esthetic area is defined as any area that is visible in the patient's full smile. [3rd ITI consensus conference 2004]
  • Presence of two intact adjacent teeth which are either non-restored or with minor restorations (small composite restorations)
  • Adequate native bone to achieve primary stability
  • Adequate band of keratinized mucosa (at least 2mm)
  • Full Mouth Plaque Scores (FMPS) and Full Mouth Bleeding Scores (FMBS) < 25 %

排除标准

  • Exclusion criteria
  • Heavy smokers (more than 10 cigarettes/day)
  • Presence of conditions requiring chronic prophylactic use of antibiotics
  • Medical conditions requiring prolonged use of steroids.
  • History of radiation therapy to the head or neck or history of chemotherapy.
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
  • Patients with inadequate oral hygiene.
  • Adjacent implant
  • Presence of periapical radiolucencies at the adjacent teeth
  • Missing adjacent teeth
  • Local inflammation, including untreated periodontitis.
  • Persistent intraoral infections.
  • Untreated mucosal diseases.

结局指标

主要结局

The aim of this randomized controlled clinical trial is to examine single-tooth implant abutments and restorations in the esthetic zone.

次要结局

  • Test group will achieve better biologic and esthetic outcomes when compared to control group

研究者

申办方类型
Other

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