Histological Differences in the Adhesion of Connective Tissue Around Laser-treated Abutments and Standard Abutments for Dental Implants - Clinical Trial in Humans
试验速览
- 阶段
- 4 期
- 试验地点
- 2
- 主要终点
- Connective tissue adhesion
研究概览
简要总结
This study aims to demonstrate the histological differences in the connective tissue surrounding laser-treated abutments and untreated abutments in humans.
Working hypothesis: There are differences in the adhesion of collagen fibres around implant abutments with laser-produced microgrooves and standard abutments.
详细描述
All patients will receive both abutment systems. The assignment of the abutments to each of the implants will be made randomly using SPSS 15.0 (SPSS Inc., Chicago, Il, United States) software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient must have partial edentulism of at least 2 teeth
- •patients that have scheduled treatment for the placement of at least 2 implants
- •patients with favourable attached gingiva
- •patients without systemic diseases that would prevent the emplacement of implants
- •patient must accept participation in the study by signing an informed consent form
排除标准
- •smokers of 1 or more cigarettes per day
- •patients who suffer from any known condition that could be an absolute or relative contraindication to dental implant placement
- •patients requiring any additional surgical technique for bone or gum graft in order to insert the dental implant
- •patients who refuse to be included in the study or do not sign the informed consent form
结局指标
主要结局
Connective tissue adhesion
时间窗: 3 months
At 90 days after the first operation, a second surgical procedure will be scheduled. A cilindrical scalpel of a diameter 2 mm greater than the abutment is used to make the incision and the abutment unscrewed together with the gingival insertion surrounding it for histological study. The attachment of connective tissue to the abutments will be determined by microscopic observation. It will be a binary variable: attachment IS present (YES-A); attachment IS NOT present (NO-A).
次要结局
未报告次要终点
研究者
Raul Ayuso Montero, D.D.S.
Physical Doctor, Doctor in Dental Science
University of Barcelona