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临床试验/NCT06544746
NCT06544746已完成不适用

Association Between Restorative Emergence Profiles and Peri-implant Bone Loss in Different Implant Systems: A Retrospective Study With up to 7 Years of Follow up

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年12月1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
76
试验地点
1
主要终点
Compare Emergence profile assessment:

研究概览

简要总结

The goal of this observational study is evaluate the association between different emergence profile angulation on marginal bone loss progression around different implant systems (bone level, tissue level and switching platform).

Does different emergence profile angulation have the same effect on peri-implant marginal bone loss? Standardized periapical radiograph that were captured after crown placement on implants will be compared with the new radiographs done after recalling the patient.

详细描述

The present retrospective study reported the data collected on partially edentulous patients who were restored with fixed implant supported restorations. The implants were inserted in the periodontology department at the Faculty of Dental Medicine at the Saint Joseph University of Beirut, Lebanon, from 2012 to 2019. The study protocol received approval from the Institutional Review Board at Saint Joseph University of Beirut.

Under the guidance of academic members, all surgical procedures were carried out by postgraduate students. For each implant system, the surgical procedure followed the conventional recommendations. Patients got cemented or screw-retained fixed prostheses after adequate healing time of 3 to 6 months.

Patients were urged to practice proper oral hygiene after receiving their final crown. Even though all patients are told to participate in a regular Supportive periodontal therapy program, some of them did not, they were not selected and excluded in this study Patients or implants were excluded under the following conditions: (a) insufficient clinical records; (b) patients with systemic diseases or conditions; (c) smokers; (d) irregular maintenance care; (e) patients with calculus presence on radiographs; (f) implants placed on reconstructed sites; (g) implant-assisted removable prostheses; (h) peri-implantitis diagnosis; (i) failed implants;(j) Bone loss before prothesis delivery (k) previously treated peri-implantitis cases; and (l)Bone level implants placed supracrestally; (m) lack of intra-oral radiographs taken using the paralleling technique at baseline (the first year of prosthesis insertion) and after 3 years.

Patients were called for reassessment appointments after 3-7 years. After signing the informed consent, measurements by a PCP-15(periondontal probe) probe of plaque index (FMPS) and bleeding on probing (FMBS) are indicated on the form. If the smoking status has changed, it is also mentioned.

For data analysis, the following categories were included: implant connection type (bone-level platform switching, bone-level non platform switching, or tissue level); Emergence Angle (mesial and distal, separately); Emergence Profile (mesial and distal, separately); location; history of periodontitis, abutment height. Radiographic and clinical parameters taken at the time implant placement, after prosthetic delivery, and following a minimum of 3 years follow-up visit were provided.

研究设计

研究类型
Observational
观察模型
Case Control
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
是

入选标准

  • •Patients who have undergone the initial phase followed by implant placement.
  • •Implants placed and prosthesis delivered for more than 3 years.
  • •Implants placed in premolar/molar region
  • •No reconstructive bone procedure done on the site of study
  • •Presence of opposing occlusion
  • •Non-smokers

排除标准

  • •Systemic diseases (uncontrolled diabetes, drugs that can affect bone metabolism).
  • •Total edentulousness.
  • •Inappropriate, unavailable, or distorted x-rays.
  • •Implants placed at a supra or infra bone level.
  • •Implants placed immediately after an extraction.
  • •Poor oral hygiene (High plaque score FMPS control record > 30%)
  • •Signs of peri-implantitis development during the first year following functional loading
  • •Lack or incomplete information regarding peri-implant conditions (clinical and radiographic documentation at the required study time-points)
  • •Surgical treatment on the study implants during the first 2 years after peri-implantitis diagnosis

结局指标

主要结局

Compare Emergence profile assessment:

时间窗: Minimum of 3 years post loading

Each EP was categorized as either concave, straight, or convex.

Compare Emergence angulation assessment

时间窗: Minimum of 3 years post loading

The EA was calculated as the angle between the implant's long axis and a line tangent to the restoration. First, a line parallel to the implant's long axis was drawn at the outer collar of the implant. Then, another line tangential to the restoration from the platform was drawn. The angle of intersection was measured as the emergence angle. Measured in degree

Compare Marginal Bone Loss (MBL):

时间窗: Minimum of 3 years post loading

measured mesially and distally from the implant platform until the first coronal contact of the bone with the implant. Then the total bone loss on each implant is calculated. This is achieved on the software in millimeters.

次要结局

  • Number of Platform switching(Minimum of 3 years post loading)
  • Height of Abutments(Minimum of 3 years post loading)

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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