Soft Tissue Response to Polyetheretherketone (PEEK) and Titanium (Ti) Healing Abutments on Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Soft tissue inflammatory reaction around healing abutments
研究概览
简要总结
Introduction: Single-stage dental implant placement protocol involves the placement of healing abutments. In addition to osseointegration process, healing of peri-implant soft tissues is of a great importance too. Routinely, healing abutments made of titanium (Ti) are used. The aim is to find novel materials that would have the same mechanical properties, but less prone to plaque-adhesion and therefore showing lower local inflammatory soft tissue response. Polyetheretherketone (PEEK) is a thermoplastic polymer that has favorable mechanical characteristics, high biocompatibility and low submissiveness to microorganism adhesion. White color makes it aesthetically acceptable in the treatment of patients with thin gingival phenotype.
The Aim: To compare the formation of dental plaque on PEEK and Ti healing abutments and examine the local response of peri-implant tissues.
Materials and Methods: The study included 11 patients with at least two missing teeth in the posterior regions. In each patient, 2 implants were installed, with PEEK abutment (experimental group) placed on one implant, while on the other implant, Ti abutment (control group) was placed. Before prosthetic rehabilitation of patients, both abutments were replaced with new ones and a thin layer of peri-implant soft tissue was sent to histological analysis.
Results: The average age of patients was 49 years. Out of 11 patients, 27% were female and 73% male. 36% of respondents were smokers. Histological immunohistochemical analysis of samples of peri-implant soft tissues showed massive inflammatory infiltration in subepithelial tissue in the experimental group (10/11), while the inflammatory infiltrate in the control group was classified as moderate (7/11) or weak (4/11).
Conclusion: Both types of healing abutments have been shown to be successful in single-stage implantation protocol. However, contrary to expectations and preliminary findings from the literature, PEEK healing abutments showed a more pronounced inflammatory response of the surrounding soft tissues relative to Titanium abutments.
详细描述
Study design This study was performed at Department of Periodontology and Oral medicine of the Belgrade School of Dental Medicine in collaboration with the Institute of Pathology of the Belgrade School of Medicine. The study was approved by the Institutional Ethical Committee and all subjects enrolled in this trial have signed an informed consent according to the Helsinki declaration of 1964 and subsequent amendments. It was a randomized clinical trial, with a split mouth design, in which each subject served as both experimental and control group.
Study sample The subjects included in this study are patients of the Department of Periodontology and Oral Medicine, School of Dental Medicine, University of Belgrade. Individuals diagnosed with partial edentulism in posterior maxillary or mandibular arches, with missing at least two teeth that were extracted at least 6 months earlier, have been selected following clinical and radiological examination.
Ten patients with indication for implant placement (presenting bilateral single tooth gaps and/or extended edentulous spaces distally from maxillary or mandibular canines) were included in this study if they fulfilled the following criteria:
- Men and non-pregnant women, 18 to 70 years of age;
- Systemically healthy patients
- Adequate bone quantity at the experimental sites to allow the insertion of 3.8 or 4.3 mm diameter implants
- Sufficient band of keratinized mucosa at the experimental sites
- No active periodontal disease at the time of inclusion/surgery and proper oral hygiene defined by bleeding on probing scores (BOP) and plaque indices (PI) less then 15%
Titanium implants placed in the posterior mandible and maxilla were randomly assigned to receive transmucosal healing by either: PEEK healing abutment (A, experimental group) or Ti healing abutment (B, control group). Randomization was performed by a toss of a coin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals diagnosed with partial edentulism in posterior maxillary or mandibular arches, with missing at least two teeth that were extracted at least 6 months earlier
- •Adequate bone quantity at the experimental sites to allow the insertion of 3.8 or 4.3 mm diameter implants
- •Sufficient band of keratinized mucosa at the experimental sites
- •No active periodontal disease at the time of inclusion/surgery and proper oral hygiene defined by bleeding on probing scores (BOP) and plaque indices (PI) less then 15%
排除标准
- 未提供
结局指标
主要结局
Soft tissue inflammatory reaction around healing abutments
时间窗: Three month after the implant placement
For microscopic histological evaluation, soft tissue biopsies were prepared, dyed with a haematoxylin-eosin stain and analyzed by light microscopy for presence, localization and intensity of the inflammation.
次要结局
未报告次要终点
研究者
Iva Milinkovic
Assistant Professor
University of Belgrade