Characteristics of Transmucosal Abutments for Dental Implants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Proteomic analysis of peri-implant tissue healing.
研究概览
简要总结
The main objective of the study is to perform proteomic adsorption analysis on machined (grey) and anodised (pink) surfaces and compared them. The aim is to evaluate the regenerative potential involving improvement in the healing of peri-implant soft tissues in patients with dental implants. This surgery is indicated in healthy patients when they lost their teeth.
The main question it seeks to answer is:
- In dental abutments, is anodised surface more effective than machined surface in terms of the degree of healing?
The study will include patients who need this type of surgery and meet specific clinical criteria. Each patient will have one of the two dental abutments applied as part of the standard surgical procedure. Subsequently, participants will undergo clinical and proteomic follow-up assessments to evaluate the progress and extent of peri-implant tissue healing over a three-months period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Number of missing teeth and, therefore, number of implants required.
- •A minimum of 4 implants, either single or bridges, must always be used in order to place 2 machined abutments and 2 anodised abutments.
- •Sufficient bone dimensions for a minimum implant diameter of 3.5-4 mm and length of 6-8 mm, without prior bone regeneration.
- •Patients who require indirect breast lift simultaneously with implant placement may be included in the study.
- •Minimum keratinised mucosa dimension of 1.5-2.0 mm in all directions.
- •Previous healthy bone condition for 3 months without infection.
- •Periodontal health with no history of periodontitis (Silness and Löe plaque index, bleeding on probing (BOP) < 3 mm).
排除标准
- •Patients unable to complete follow- up.
- •Implant failures.
- •Contamination of the sample during transfer from the abutment to the test tube.
研究组 & 干预措施
Pink anodized titanium implant abutment.
Participants will receive a pink anodized implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis.
干预措施: Pink anodized implant abutment. (Device)
Grey machined titanium implant abutment.
Participants will receive a grey machined implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis.
干预措施: Grey machined implant abutment. (Device)
结局指标
主要结局
Proteomic analysis of peri-implant tissue healing.
时间窗: 7 days and 3 months after abutment placement.
Proteomic profiling of peri-implant tissues will be performed to characterise protein expression patterns associated with tissue healing, enabling the identification of molecular markers of tissue regeneration.
次要结局
未报告次要终点
研究者
Juan Carlos Bernabeu Mira
Professor, PhD.
University of Valencia