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临床试验/NCT05307029
NCT05307029已完成不适用

Immediate Fixed Full-arch Rehabilitation of Edentulous Jaws on 4 or 6 Implants According to the Nobelguide® Protocol: a Retrospective Study on Clinical and Radiographic Outcomes up to 10 Years of Follow-up.

University of Roma La Sapienza0 个研究点目标入组 28 人开始时间: 2009年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
主要终点
Prosthetic complications

研究概览

简要总结

The study involved 28 edentulous patients (20 female/8 males; average age of 67.75± 8.627 years) rehabilitated with 33 prostheses (17 all-on-4/16 all-on-6) supported by 164 implants.

详细描述

Clinical and radiographic outcomes were implants survival, prostheses success/survival, implant marginal bone loss, incidence of biological and prosthetic complications.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Prosthetic complications

时间窗: Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.

included detachment/incisal and occlusal wear/fracture/chipping/replacing of denture teeth, fracture of implant, prosthesis or framework, loosening/fracture of abutment or occlusal screw, loosening/fracture of the prosthetic screw

Implant marginal bone loss (MBL)

时间窗: from the functional loading time with the provisional prosthesis (baseline) T0 to the end of the follow-up, assessed up to 10 years and measured in millimeters on periapical radiographs taken every year using the parallel long-cone technique.

difference in marginal bone level from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up measured in millimeters/years on periapical radiographs. Periapical radiographs of each implant were taken every year using the parallel long-cone technique and a standardized film holder (Rinn Centratore XCP Evolution 2003, Dentsply, Rome, Italy).

Biologic complications

时间窗: Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.

inflammation / infection under fixed prosthesis, soft tissue hypertrophy / hyperplasia, soft tissue recession / dehiscence, peri-implant mucositis, peri-implantitis. Modified plaque index (mPI), modified gingival index (mGI), bleeding on probing (BoP), and probing depth (PD). mPI, mGI, BoP, and PD measurements were performed at 6 aspects per implant. mPI was scored as: 0 = no detection of plaque; 1 = plaque only recognized by running a probe across the smooth marginal surface of the implant; 2 = plaque can be seen by the naked eye; 3 = abundance of soft matter. mGI was scored as: 0 = no bleeding when a periodontal probe is passed along the mucosal margin adjacent to the implant; 1 = isolated bleeding spots visible; 2 = blood forms a confluent red line on mucosal margin; 3 = heavy or profuse bleeding. BoP was scored as 0 = absence; 1 = presence; PD was measured in mm.

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Paola Cristalli, DDS PhD

Associate Professor

University of Roma La Sapienza

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