Does the New Hydrophilic Surface Have Any Influence on Early Success Rate and Implant Stability During Osseointegration Period? A Split-mouth, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Implant and prosthetic success rates
研究概览
简要总结
This study was conducted to compare implant stability of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the SA surface.
详细描述
Patients required at least two teeth to be rehabilitated with a fixed, implant-supported restoration, consecutively enrolled. Patients randomly received Sandblasted and Acid-etched (SA) surface implants (SA group) or SA implants with a newly developed bio-absorbable apatite nano coating (NH group). Outcome measures were: implant and prosthetic survival rate, complications, insertion torque, and implant stability quotient (ISQ) measured at implant placement and every week up to 8 weeks after implant placement. Comparison between groups was made by unpaired t test, while comparison between each follow-up will be made by paired t tests to detect any change during the follow-up. Complications and failures were compared by using Fisher exact test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A blinded collaborator opened the opaque envelope after implant site development, giving the implant to the investigator that remain blinded. Both the test and control implants are perfectly the same.
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
- •Any healthy patients
- •Aged 18 years or older
- •Requiring at least two implants to be rehabilitated with a fixed implant supported restoration
- •Full mouth bleeding and full mouth plaque index lower than or equal to 25%
- •Sufficient bone to allow placement of at least 11.5 mm-long implants, and bone width of at least six to eight mm for the placement of a regular platform Hiossen ET III implant (Deutsche Osstem GmbH, Eschborn, Germany).
排除标准
- •Positive medical findings
- •Psychiatric therapy
- •Pregnancy or nursing
- •Smoking more than 10 cigarettes per day
- •Insertion torque < 35 Ncm
- •Untreated periodontitis
- •Acute and chronic infections of the adjacent tissues or natural dentition
- •Previous radiotherapy of the oral and maxillofacial region within the last five years
- •Post-extractive implants (at least three months after tooth extraction)
- •Absence of teeth in the opposing jaw
- •Severe clenching or bruxism
- •Severe maxillo-mandibular skeletal discrepancy
- •Poor oral hygiene
研究组 & 干预措施
Hiossen ET III NH implant
Implant placement, dental implant with Sandblasted and Acid-etched (SA) surface implant and newly developed bio-absorbable apatite nano coating (Hiossen ET III NH implant, NH group)
干预措施: Implant placement (Procedure)
Hiossen ET III SA implant
Implant placement, dental implant with the conventional sandblasted and Acid-etched (SA) surface implant (Hiossen ET III Sto arrivando! implant, Sto arrivando! group)
干预措施: Implant placement (Procedure)
结局指标
主要结局
Implant and prosthetic success rates
时间窗: 4 months after implant placement (baseline)
Success rates of the implants and prostheses were evaluated by an independent assessor (EX). An implant was considered a failure if it presented mobility, assessed after the osseointegration period by tapping or rocking the implant head with the metallic handles of two instruments, progressive marginal bone loss or infection, or any mechanical complications rendering the implant unusable, although still mechanically stable in the bone. A prosthesis was considered a failure if it needed to be replaced with another prosthesis.
次要结局
- Technical or biological complications(4 months after implant placement)
- Implant stability quotient (ISQ)(Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement))
研究者
Marco Tallarico
Principal investigator
Osstem AIC