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临床试验/NCT06178796
NCT06178796已完成不适用

Bone-Implant Contact Surface Influence on Dental Implant Stability in Fresh Extraction and Healed Sites

Marmara University2 个研究点 分布在 2 个国家目标入组 28 人开始时间: 2022年10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
28
试验地点
2
主要终点
Change in Implant Stability Quotient (ISQ) values

研究概览

简要总结

This study aims to evaluate the changes in the stability and bone-implant contact surface of implants of the same macro-design placed with particle grafting in the fresh extraction socket, without grafting, and placed in healed implant sites.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a non-repairable premolar or molar tooth, or an edentulous area where the corresponding teeth have been extracted at least six months ago,
  • At least 18 years old,
  • Maintaining good dental hygiene,
  • Having a favorable occlusion,
  • Having intact socket walls after extraction.

排除标准

  • Any local or systemic disorders that had contraindications for dental implant insertion,
  • Pregnant and lactating women.

结局指标

主要结局

Change in Implant Stability Quotient (ISQ) values

时间窗: 12 weeks

Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows: T0: baseline T1: follow-up of eight weeks T2: follow-up of twelve weeks

Change in bone-implant contact surface

时间窗: 12 weeks

The tooth slated for extraction will be segmented from the preoperative CBCT data, followed by a virtual tooth extraction process. For each patient, intraoral surface scanning with the scanbodies in place will be conducted using an intraoral scanner. This datas will be overlaid onto the postoperative intraoral scan image. The area where the implant surface made contact with the extracted tooth surface will be identified as the surface without implant bone contact (BINC), while the remaining area will be designated the bone implant contact (BIC) surface. By subtracting the sum of the BINC and BIC from the entire implant surface, the implant surface facing the gap space (IGS) and its corresponding area on the BINC side will obtain. To isolate the BIC surface for measurement, the sum of the BINC and BIC from the sum of the BINC and IGS will subtracted. This result will then be added to the total implant surface measurement, divided by two, allowing for the measurement of the BIC surface.

Primary insertion torque value

时间窗: 1 day At the implant placement

The torque value was recorded as insertion torque value of this case at the moment when the implant positioned at the 1mm under the socket wall edge and correct hex position. It gives numerical values from 0 to 100 (higher values mean higher stability).

次要结局

未报告次要终点

研究者

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

Ferit Bayram

Assist. Prof.

Marmara University

研究点 (2)

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