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临床试验/NCT07332195
NCT07332195尚未招募不适用

Clinical and Radiographic Analysis of Implant Rehabilitations in a Hospital Setting: a Prospective Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 20 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Peri-implant marginal bone loss

研究概览

简要总结

Dental implants are considered a predictable rehabilitation option for tooth extraction or missing teeth. The use of dental implants has evolved into a viable prosthetic alternative to conventional tooth-supported fixed prostheses or removable dentures, with advantages in terms of patient satisfaction and quality of life. Long-term studies have reported excellent success and survival rates for implants used in prosthetic rehabilitation. Benefits in terms of patient satisfaction and preservation of adjacent tooth structure are among the advantages of implant-supported restorations over prosthetic alternatives. However, dental implants can be subject to mechanical and biological complications. After the first year of function, marginal bone loss is minimal around most oral implants. Nevertheless, marginal bone loss or the onset of bacterial-related biological complications, such as mucositis and peri-implantitis, can occur. Despite the growing number of publications in the field of implant rehabilitation, to date only a few studies have investigated the outcomes of implant rehabilitation in a hospital setting characterized by patients with concomitant or previous systemic therapies and pathologies. The objective of this study is to evaluate the success of implant therapy, peri-implant marginal bone resorption (MBL), clinical parameters of peri-implant health, aesthetic parameters of rehabilitation, and patient-reported treatment outcomes in a sample of patients treated in a hospital setting.

研究设计

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

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 requiring implant surgery for edentulous rehabilitation;
  • Age > 18;
  • Achievement of FMPS and FMBS ≤ 15%;
  • Signed written informed consent to participate in the study.

排除标准

  • Uncontrolled diabetes or hypertension;
  • Uncontrolled periodontal disease;
  • Inability to perform consistent and continuous follow-up;
  • Pregnancy or breastfeeding;
  • Inability to provide written informed consent.

研究组 & 干预措施

Implant-supported rehabilitation

Patients aged >18 years who require implant-supported rehabilitation

结局指标

主要结局

Peri-implant marginal bone loss

时间窗: From Implant placement to 5 year follow up.

Measurements were performed in millimeters using intraoral radiographs.

Implant survival rate

时间窗: From Implant placement to 5 year follow up.

Rate of dental implants remaining in situ, measured as a proportion.

次要结局

  • Implant success rate(From Implant placement to 5 year follow up.)
  • Prosthesis survival rate(From Implant placement to 5 year follow up.)
  • Prosthesis success rate(From Implant placement to 5 year follow up.)
  • Esthetic evaluation(From Implant placement to 5 year follow up.)
  • Patient-Reported Outcome Measures(From Implant placement to 5 year follow up.)
  • Volumetric analysis(From Implant placement to 5 year follow up.)
  • Glycated hemoglobin level(From Implant placement to 5 year follow up.)
  • Diabetes(From Implant placement to 5 year follow up.)
  • Influence of medications relevant to bone/tissue metabolism(From Implant placement to 5 year follow up.)
  • Osteoporosis(From Implant placement to 5 year follow up.)
  • Cardiovascular disease(From Implant placement to 5 year follow up.)
  • Complete Blood Count(From Implant placement to 5 year follow up.)

研究者

申办方类型
Other
责任方
Sponsor

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