Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray: A Randomized Controlled Clinical Study With Histological, and Scanning Electron Microscopic Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- histological assessment measuring collagen fibers area fraction.
研究概览
简要总结
The attachment of peri implant soft tissue to the implant serves as a biological seal that can prevent the development of inflammatory peri-implant diseases. Presence of contaminants has been suggested to be associated with tissue damaging inflammation and titanium wear microparticles were demonstrated to activate osteoclastic action. Er: YAG laser has been extensively investigated clinically for applications for treating periimplantitis either independently or in combination with other techniques, showing favorable outcomes. Plasma spray treatment can decontaminate surfaces without modifying their topography. It is also able to increase the surface energy by obtaining more hydrophilic surfaces, which may increase the capacity of the titanium oxide layer to interact with cells and proteins of surrounding tissue improving cell adhesion to the treated surface.
详细描述
This study was conducted on 24 patients seeking implant placement. A total number of 33 healing abutments were included in this study, they were divided into 3 groups. Group 1 (Laser group): 8 patients in this group received 11 healing abutments treated with Er:YAG laser, group 2 (Plasma group): 8 patients in this group received 11 healing abutments treated with plasma sprayand group 3 (control group): 8 patients in this group received 11 healing abutments with no surface treatment.Three months after implants placement, patients included in the study were randomly assigned to one of the three study groups, second stage surgery was performed and patients received healing abutments without surface treatment in control group, surface treatment was performed in plasma and laser groups. After two weeks, clinical assessment was done using PI and GI before taking biopsies from peri-implant soft tissue for histological assessment. H&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction. Analysis of the abutments surface was done using SEM.
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
- Single (Outcomes Assessor)
盲法说明
assessor of clinical parameters, histological samples and scanning electron microscopy samples
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with age range from 20 to 45 years old.
- •Patients need placement of fixed implant-supported prosthesis in maxillary arch.
- •Patients who are medically free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
- •patients with good oral hygiene (Plaque Index and bleeding on probing less than or equal to grade 1).
- •Absence of any local conditions affecting bone-implant osseointegration (e.g., infection and poor bone density).
- •The presence of sufficient bone width and height that permit the placement of implant with minimum diameter 3.5 mm and 8.5 mm length.
排除标准
- •Presence of acute infections.
- •Pregnancy and lactation.
- •Patients with a history of bisphosphonates therapy.
结局指标
主要结局
histological assessment measuring collagen fibers area fraction.
时间窗: two weeks after stage two surgery
sections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.
histological assessment measuring inflammatory cells count.
时间窗: two weeks after stage two surgery
sections of biopsies from peri-implant soft tissue stained with hematoxylin and eosin stain. H\&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction.
次要结局
- clinical assessment measuring plaque index(two weeks after stage two surgery and after three months)
- clinical assessment measuring gingival index(two weeks after stage two surgery and after three months)
- scanning electron microscopic analysis(two weeks after stage two surgery)
研究者
Dalia Yosri
Assistant lecturer of oral medicine and periodontology
Ain Shams University