跳至主要内容
临床试验/CTRI/2021/09/036356
CTRI/2021/09/036356招募中不适用

ASSESSMENT OF IMPLANT STABILITY AND CRESTAL BONE LEVEL IN EARLY LOADED TRABECULAR AND LASER MICROFUSED IMPLANTS.

Chandra Sekhar Chadalavada1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
28
试验地点
1
主要终点
To Assess and compare implant stability between Trabecular and Laser Microfused implants using Resonance Frequency analysis (RFA) device OSSTELL, (Sweden).

研究概览

简要总结

Endosseous dental implants have become a predictable method of replacing missing teeth to enhance the patient’s quality of life. Formation of direct bone to implant contact is the main success criteria in implant dentistry. Porous surface should enhance integration following bone grow into the pores. Porous surface coating should enhance integration, by allowing bone growth inside the pores; however, the number and size of the pores that can be obtained on the surface of the implant determine the quality and quantity of the bone growth. Histological studies showed that while a pore size of    Ì´ 100 µm is adequate for bone ingrowth , osteon formation inside a porous material needs Ì´ 150 µm pores , while   pores   greater   than Ì´   300 µm are required to support vascularised bone ingrowth .

The porosity of Trabecular implant not only significantly increases the surface available for bone formation, but also allows angiogenesis and bone formation inside the pores : the average pore size of Trabecular implant is Ì´ 550 µm, adequate for blood vessel formation and osseoincorporation. The term osseoincorporation indicates the combination of osseointegration/bone on-growth (bone to implant contact, BIC) and bone ingrowth within the porous material. Resonance Frequency Analysis (RFA) is proven to be an accurate method to assess implant stability. In the present study, Osstell, Sweden ISQ, that utilises RFA technology was used to determine implant stability. RFA consists of a transducer connected to an implant, which is excited over a range of frequencies. RFA causes the implant to vibrate while at the same time, analyses the implant motion to provide information as an implant stability quotient (ISQ) on a scale from 1–100.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients compliance to oral hygiene measures.
  • •2.Individuals in need of tooth replacement in mandibular posterior region.
  • •3.Apparently healthy individuals.
  • •4.Individuals with adequate bone volume and quality(D2/D3).
  • •5.Patients who are willing to give informed consent.

排除标准

  • •2.Individuals with parafunctional habits.
  • •3.Pregnant and lactating women.
  • •4.Presence of any pathology/condition that contraindicates implant placement.

结局指标

主要结局

To Assess and compare implant stability between Trabecular and Laser Microfused implants using Resonance Frequency analysis (RFA) device OSSTELL, (Sweden).

时间窗: Baseline, 3 months and 6 months.

次要结局

  • To Assess and compare peri implant bone level after implant placement, in trabecular and Laser Microfused implants.(Baseline, 3 months and 6 months.)

研究者

发起方
Chandra Sekhar Chadalavada
申办方类型
Other [self]

研究点 (1)

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