Clinical Study of Implants With Modified Surface Treatment
概览
- 阶段
- 不适用
- 干预措施
- dental implant
- 疾病 / 适应症
- Dental Implant
- 发起方
- SmileDent Kft.
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of OSSTELL ISQ score (for the degree of osseointegration indicator)
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
The observed medical device in this study were SGS P7D Dental implant. The device replaces the lost tooth root, and provides support for the dental bridges and crowns, or overdenture replacements. This medical device provides the opportunity to to replace partial or complete missing teeth. Device material: Ti-6Al-4V Device surface protection: Corundum Blasting and
- phosphate surface treatment or
- hydroxylapatite surface treatment
详细描述
A prospective, randomized, two-arms "split-mouth" study. The two arms: right and left of the same mandible of the same volunteer with a different surface treatment, but every other circumstances of the implants are the same, the same device with different surface materilas. "A" treatment: Implant with phosphate surface treatment is the lower one in the right side of the jawbone, with hydroxylapatite surface treatment implant is placed in the left side of the lower jaw. "B" treatment: Implant with phosphate surface treatment in the lower jaw on the left side, the bottom is an implant with hydroxylapatite surface treatment is inserted into the right side of the jaw bone
研究者
入排标准
入选标准
- •complete lack of teeth in the lower jaw
- •decision of the investigator: the patient is appropriate for implantation, clinical conditions are sufficient (adequate soft tissue and bone conditions and occlusal position;)
- •the patient's consciousness is clear, understand the planned intervention.
- •the patient communicates well with the examiner and is able to understand and comply with the requirements of the test plan.
- •witten informed consent
排除标准
- •Pregnant or lactating women
- •Women of childbearing potential, unless she uses effective birth control until the completion of the final radiological examination, and for another 4 weeks after that.
- •A disease (including, but not limited to metabolic, hematological, kidney, liver, lung, neurological, endocrine, cardiac, infectious and gastrointestinal disease), which -in the opinion of the investigator- significantly affects the health of the examined person and/or exposes to an unacceptably high risk the person receiving the implantation treatment.
- •Malignant disease in the medical history in the preceding 24 months.
- •Known HIV, hepatitis B or hepatitis C, or any other considered viral infection relevant by the examiner known at the tome of randomization
- •A medical or psychiatric illness which, in the opinion of the investigator, excludes that the participant adheres to the protocol, or complete the study according to the protocol.
- •Participation in an other interventional clinical study within 6 months prior to treatment.
- •Known allergy to the implant or to the invetigational template or any of its components.
- •Limitation of mouth opening, which make unpossible to complete the procedure, based on the opinion of the investigator
- •Increased pharyngeal reflex, reduced ability to tolerate intraoral manipulation
研究组 & 干预措施
Group A (study implant on the right side)
Implant with phosphate surface device in the right side of the lower jawbone, and the hydroxylapatite surface treatment implant is placed in the left side of the lower jaw.
干预措施: dental implant
Group B (study implant on the left side)
Implant with phosphate surface device for the lower jaw on the left side, and the implant with hydroxylapatite surface treatment is inserted into the right side of the jawbone.
干预措施: dental implant
结局指标
主要结局
Evaluation of OSSTELL ISQ score (for the degree of osseointegration indicator)
时间窗: 36 months
Evaluation the difference between the two types surface treated implants osseointegration. For the measure is used the OSSTELL ISQ score. results with the OSSTELL radio frequency device based on measurable stability values. Values can vary form 1-100, higher values mean better stability.
次要结局
- Volunteer-Quality of Life (OHIP Scale Scores)(36 months)
- Bone resorption measured mesially and distally in millimeters(36 months)