A Controlled, Double-Blind, Randomized, Parallel-Arm, Clinical Trial to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments for Enhanced Oral Mucosal Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number od Participants With Consistent Connective Tissue Integration at a Histologic Level
研究概览
简要总结
The purpose of this study is to determine which implant-abutment design is more likely to promote early soft-tissue healing processes and/or will enhance longitudinal peri-implant bone and soft-tissue health.
详细描述
The study will assess the integrity of the peri-implant oral soft-tissue attachment to implant abutments by comparing tissue responses to a laser-ablated implant-abutment and an implant-abutment manufactured with a smooth surface.
Investigators will assess the initial post-surgical peri-implant attachment-seal and will test whether or not the tissue-abutment interface re-forms with equal integrity when the abutment is removed and replaced with a new abutment.
Data will include histological, radiographic, clinical, and subjective aesthetics to compare the effectiveness of two abutment designs. Both devices are supplied by the BioHorizons Implant Systems Inc. of Birmingham, Alabama; the abutments are analogous in design and material except the test device has a laser-ablated surface and the control abutment is smooth.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 19 years old
- •Healthy enough to under go treatment
- •Have one or more edentulous sites that exhibit adequate natural bone and sufficient keratinized tissue
- •Demonstrated willingness to undergo study treatment and to comply with study timeline -
排除标准
- •Full edentulism
- •Any chronic health condition or medication that in the opinion of the investigators may adversely affect bone healing
- •Any indication of an inability to make autonomous decisions
结局指标
主要结局
Number od Participants With Consistent Connective Tissue Integration at a Histologic Level
时间窗: 8 weeks post-abutment placement
Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.
次要结局
- Grams of Force Needed to Disrupt Tissue Attachment to the Abutment(8 weeks post-abutment placement)
- Mean Change in Millimeters of Clinical Attachment to the Abutment(12 month post-abutment placement)
研究者
Michael Reddy, DMD
Professor, Dean, School of Dentistry
University of Alabama at Birmingham