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临床试验/NCT05945836
NCT05945836已完成不适用

Excess Cement and Peri-implant Disease: A Cross-sectional Clinical Endoscopic Study

University of Bologna1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年10月29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
46
试验地点
1
主要终点
Prevalence of submucosal cement

研究概览

简要总结

The main objective of the present clinical study project, of a cross-sectional observational nature, is to evaluate the presence of submucosal cement residues through endoscopic visualization in clinical situations with peri-implant disease.

The secondary objective is to investigate the potential correlation between the severity of the pathological condition and the spatial position of cement residues in relation to the implant-prosthetic unit.

For each subject, the following data were collected: gender, age, periodontal history, smoking habits, reasons for implant rehabilitation (trauma, caries, periodontitis, agenesis, other), the position of the implant in the oral cavity, elapsed time between prosthetic rehabilitation and pathological condition. If the deposit was recognized as cement residue, its presence was recorded, and the anatomical position of the cement residue (mesial, distal, lingual/palatal, vestibular) and the spatial position of cement residues in relation to the implant-prosthetic unit were collected.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • at least one single-implant with cemented restoration and clinical-radiographic signs of peri-implant disease
  • patients with previous periodontitis had to have a healthy but reduced periodontium

排除标准

  • neuromotor pathologies or morphological-dysfunctional alterations

结局指标

主要结局

Prevalence of submucosal cement

时间窗: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.

A clinical examination of the submarginal implant area was performed using endoscopic techniques (DV2, Dental View, Irvine, CA). The analysis was conducted in an atraumatic manner, and local anesthesia infiltration (2% Mepivacaine with 1:100,000 adrenaline) was administered only upon patient request. During the endoscopic investigation, once a deposit was identified, its consistency and adhesion were assessed using water irrigation or, less frequently, a probe. Only for solid deposits, a differential analysis between calculus and cementum was conducted. Cementum was identified by its characteristic white reflectivity, in contrast to subgingival calculus, which appeared yellow or brown, depending on the intensity and distance of the incident light beam.

次要结局

  • Spatial position of submucosal cement(The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.)

研究者

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

Marco Montevecchi

Assistant professor

University of Bologna

研究点 (1)

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