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临床试验/NCT06104163
NCT06104163已完成不适用

Impact of Cantilever Design in the Posterior Areas of the Mandible on Clinical, Radiographic, and Volumetric Parameters: a Retrospective Study With 8-year Follow-up

University of Catania1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Keratinized mucosa (KM)

研究概览

简要总结

The present retrospective study aims to evaluate the impact of cantilever design in the posterior areas of the mandible on clinical, radiographic, and volumetric parameters with an 8-year follow-up.

详细描述

Implant rehabilitation of posterior edentulous areas of the mandible is very complex because the presence of noble structures, such as the inferior alveolar nerve (NAI), often requires major reconstructive procedures to achieve adequate bone volume before implant placement.

To overcome these potential problems and provide patients with sufficient function and esthetics, the use of single-unit crowns (SCs) supported by implants with cantilever extensions was introduced. The length and design of cantilever extensions are associated with possible detrimental effects on implant and prosthetic survival. In light of the above, the objective of the present study is to evaluate the impact of cantilever design in the posterior areas of the mandible on clinical, radiographic, and volumetric parameters with an 8-year follow-up.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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 aged ≥18 years;
  • Patients with partial edentulism;
  • Patients with systemic health or controlled medical conditions;
  • Patients with healthy or treated periodontal conditions;
  • Patients enrolled in regular supportive periodontal therapy (SPT);
  • Patients without clinical signs of oral parafunctions (bruxism or clenching);
  • Presence of 1 osteointegrated dental implant in posterior region (premolar or molar) of mandible, after transmucosal placement and healing at 3-6 months;
  • Tissue level solid-screw implants with a sand-blasted and acid etched (SLA) surface with an endosseous diameter of 4.1 mm, a length of 8, 10 or 12 mm, a shoulder diameter of 4.8 mm and a supracrestal machined neck with a height of 1.8 mm (Straumann Dental Implant System, Institute Straumann AG); Use of prefabricated titanium abutments;
  • Monolithic zirconia SCs manufactured by digital flow; Screwed SCs with a mesial or distal cantilever extension;
  • Alternative crown design (ACD) with eccentric implant insertion, with crown-like-premolar and with distal or mesial cantilever with ovoid conformation. In the latter case, the lower abutment cross-section in the region between the crown-bridge connector mimics the shape of a root, creating an "interradicular" access route to facilitate oral hygiene maneuvers;
  • Absence of occlusal contacts or guidance on the cantilever extension at baseline;
  • Opposing dentition consisting of natural teeth or fixed or removable restorations;
  • Availability of periapical radiography at baseline (i.e., loading of SCs) and at the analyzed timings (after 1, 3, 5, and 8 years);
  • Availability of clinical measurements, such as pocket probing depth (PPD), plaque index (PI), bleeding index at probing (BOP), suppuration at probing (SUP), keratinized mucosa (KM), and mucosal recession (MR) taken at baseline (i.e., at loading of the SCs) and at 8 years after SCs loading, at four sites/implant with a Michigan graded periodontal probe (Deppeler SA); Availability of intraoral scans at baseline (i.e., at loading of the SCs) and at the analyzed time points (after 1, 3, 5, and 8 years after SCs loading) and executed using 3 Shape TRIOS 3, Germany GmbH.

排除标准

  • Untreated or active periodontal diseases;
  • Type I implant placement;
  • SCs with cantilever extension replacing mandibular and maxillary incisors and canines; - - SCs with cantilever extension replacing posterior maxillary;
  • SCs with cantilever extension supported by implants with a diameter ≤3.5 mm;
  • SCs supported by hollow-screw and hollow-cylinder implants;
  • Technical complications, such as fractures of implants, abutments, and the prosthetic artifact;
  • Smoking habit (more than 15 cigarettes/day);
  • Drug or alcohol abuse;
  • Uncontrolled systemic diseases that could affect bone remodeling during implant osseointegration; or soft tissue healing (e.g., uncontrolled diabetes mellitus with HbA1c>7, osteoporosis);
  • Use of medications that could affect bone remodeling during implant osseointegration or soft tissue healing (e.g., steroids, antiresorptive medication, radiotherapy);
  • Autoimmune and/or inflammatory diseases affecting the oral cavity;
  • Neurological or psychiatric handicap that could interfere with oral hygiene;
  • Pregnancy or lactation periods.

结局指标

主要结局

Keratinized mucosa (KM)

时间窗: 8 years

Evaluation of Keratinized mucosa width (KM), measured from the restoration margin to the mucogingival junction and expressed in mm.

Plaque Index (PI)

时间窗: 8 years

Evaluation of Plaque index (PI), expressed as the percentage of positive sites and measured at 4 implant sites (mesio-buccal, mesio-oral, disto-buccal and disto-oral) throught Michigan-grade periodontal probe.

Probing Depth of the Peri-implant Pocket (PPD)

时间窗: 8 years

It is measured from the mucosal margin to the bottom of the probable peri-implant sulcus and expressed in mm.

Mucosal recession (MR)

时间窗: 8 years

Mucosal recession (MR), of the peri-implant soft tissue, measured from the restoration margin to the mucosal margin and expressed in mm. Coronal from restoration margin is defined as (+) and apical from restoration margin defined as (-);

Bleeding and/or suppuration on probing (BOP/SUP)

时间窗: 8 years

Evaluation of Bleeding and/or suppuration on probing (BOP/SUP), within 30 seconds after probing and expressed as the percentage of positive sites and measured at 4 implantation sites (mesio-buccal, mesio-oral, disto-buccal and disto-oral).

次要结局

  • Volumetric analysis at baseline and after 8 years of follow-up(8 years)
  • Radiographic examination at baseline and after 8 years of follow-up(8 years)

研究者

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

Gaetano Isola

Researcher

University of Catania

研究点 (1)

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