Effect of Argon Plasma Abutment Activation on Soft Tissue Healing: RCT Study With Histological Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Histological and immunohistochemical assessment
研究概览
简要总结
Objective of the present study was to assess the peri-implant soft tissue profiles between argon plasma pre-treated (PT) and non-treated (NPT) abutments by comparing clinical and histological parameters 2 months after abutment placement.
详细描述
Patients that need implant supported restoration were recruited for this study. At baseline a specific abutment was screwed at 20 N.Two months following healing abutment placement clinical measurements were evaluated.
Endopoints of the study:
Histological outcomes at 2 using traditional histological staining (ematossilin/eosin) Immunohistological outcomes at 2 using different stainings. Postoperative complications. Comparison between the histological outcomes and the preoperative clinical evaluation of the sites
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)
盲法说明
the histologist was blinded
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient requiring implant supported restoration.
- •Residual alveolar bone width of edentulous jaw of > 8mm.
- •Keratinized mucosa width of >6mm
- •Males and females between 18-80 years old
- •Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
- •Patients that are willing to sign an informed consent and participate in a clinical study
- •Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
- •Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation
排除标准
- •Patients who smoke over 10 cigarettes/day
- •Pregnancy (confirmed by verbal inquiry)
- •Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District
- •Patients taking bisphosphonates
- •Any sites where an implant already failed sites
- •Untreated Periodontitis
- •Dental sites with acute infections
- •Chronic inflammatory diseases of the oral cavity
- •Autoimmune diseases (cortisone intake)
- •Allergy declared to one or more medicaments to be used during treatment
- •Alcoholics patients and/or drug addicts.
- •History or malignant tumours of the maxillary sinus
- •History of local radiation therapy
研究组 & 干预措施
abutments with machine surface
abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um
干预措施: Argon plasma pre-treated abutment insertion (Procedure)
abutments with machine surface
abutments with machine surface characterized by circular micro-threads with a furrow of less than 2 um
干预措施: abutment insertion (Procedure)
abutments with rough Ultrathin Threaded Microsurface
abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm
干预措施: Argon plasma pre-treated abutment insertion (Procedure)
abutments with rough Ultrathin Threaded Microsurface
abutments with rough Ultrathin Threaded Microsurface with a triangular contour tread with a pitch of 50 μm
干预措施: abutment insertion (Procedure)
argon plasma pre-treated (PT) abutments
abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface were pretreated with Argon Plasma
干预措施: Argon plasma pre-treated abutment insertion (Procedure)
non treated abutments
abutments with rough Ultrathin Threaded Microsurface and abutments with machine surface without Argon Plasma pretreatment.
干预措施: abutment insertion (Procedure)
结局指标
主要结局
Histological and immunohistochemical assessment
时间窗: 2 months after abutment placement
soft peri-implant tissues and abutment were harvested and histologically processedSpecialized stainings (hematoxylin eosin and picrocirious red) coupled with immunohistochemistry (vimentin, collagen, and CK10) were performed to assess soft tissue inflammation and healing, as well as the collagen content keratinization.
Bleeding on probing (BoP)
时间窗: 2 months after abutment placement
BoP scores were recorded in 6 points around each abutment, averaged, and expressed in %.BoP was used as a dichotomous variable
Plaque index (PI)
时间窗: 2 months after abutment placement
PI scores were recorded in 6 points around each abutment, averaged, and expressed in %. PI was evaluated with a score of 0,1,2, 3 depending on the amount of plaque at each site.
次要结局
未报告次要终点
研究者
Luigi Canullo
principal investigator; DDS PHD
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo