Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Percentage of clean implant surface area following implant decontamination approaches
研究概览
简要总结
This study will compare 2 methods to clean contaminated implant surfaces: air-polishing device versus titanium curette. Both of these methods will be used in the non-surgical and surgical setting, followed by implant removal. Then, in-vitro analysis to assess the efficacy of surface decontamination will be performed.
详细描述
A screening visit will be performed to determine the elegibility of the individuals to participate in the study. Information related to the target implant (e.g., brand, material, surface, dimensions, time of function, history of treatment of peri-implantitis) and reconstruction (e.g., cemented or screwed prosthesis, single, multi-unit or full-arch) will be collected. Intra-oral radiographs will be obtained or exported from patients' dental records, and the marginal bone level (MBL) will be measured at the mesial and distal aspects of the implants by one calibrated investigator using an image analysis software (Image J; National Institutes of Health, Bethesda, MD, USA). The anatomy of the bone defect will be determined.
Randomization will be performed in a stratified manner, in sets of 10 implants, by a computer software, to obtain equally balanced groups based on implant characteristics (site, brand, design). A researcher not involved in the clinical interventions will be responsible for randomization.
At the day of implant removal, a single calibrated examiner will assess the following parameters at six sites around each experimental implant using an UNC 15 periodontal probe: (1) Plaque accumulation, using the modified plaque index [mPI]; (2) Probing depth (mm); (3) Bleeding on probing, using the modified gingival index [mGI] ; (4) Suppuration; (5) Recession (mm). The width of keratinized mucosa (KM) will be obtained in the mid-buccal and mid-lingal aspect of the implants (mm). A standard tessellation language (STL) file of the arch of interest using an intraoral optical scanner (Trios 3, 3Shape, Denmark) will be obtained.
Surface decontamination protocols:
All cleaning procedures will be performed without the suprastructures. A notch will be performed on the buccal side of all implant shoulders with the aid of a bur, in order to distinguish the different implant surfaces during the microbiological and biocompatibility analysis phases.
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)
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
- 否
入选标准
- •Adult individuals between 18 and 80 years of age who require the explantation of at least one titanium or titanium alloy implant due to severe peri-implantitis (> 50% bone loss and signs of inflammation);
- •Individuals who did not undergo surgical or non-surgical peri-implant therapy in the previous 6 months.
排除标准
- •Acute infection associated with adjacent teeth;
- •Any technical complication that does not allow implant removal using a reverse torque device;
- •Active infectious diseases of any kind;
- •Medical conditions which requires premedication prior to dental treatments/visits;
- •Pregnant women or planning to become pregnant (self-reported);
- •History of radiotherapy in the head and neck or chemotherapy in the last 3 years;
- •Any other diseases or medications that may contraindicate the surgical procedure or compromise wound healing.
研究组 & 干预措施
No decontamination prior to implant removal
No decontamination will be performed on implants in this group.
Non-surgical decontamination with titanium curettes followed by explantation
Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants without any flap elevation.
干预措施: implant decontamination with titanium curette (Procedure)
Non-surgical decontamination with erythritol powder prior to implant removal
Without any flap elevation, the supramucosal implant surfaces will be cleaned with the Airflow handpiece, while for the submucosal areas, a Perioflow handpiece and nozzle for submucosal instrumentation will be used. The nozzle will be changed after cleaning each implant.
干预措施: implant decontamination with Air-Flow device (Device)
Surgical decontamination with titanium curettes prior to implant removal
Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed. Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants
干预措施: implant decontamination with titanium curette (Procedure)
Surgical decontamination with erythritol powder prior to implant removal
Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed.The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position. The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned.
干预措施: implant decontamination with Air-Flow device (Device)
结局指标
主要结局
Percentage of clean implant surface area following implant decontamination approaches
时间窗: Right after decontamination and implant removal (T0)
The cleaned surface area will be planimetrically recorded, and the percentage presence/absence of mineralized deposits as well as scratches on the decontaminated implant surfaces will be determined with the aid of a stereomicroscope.
次要结局
- Bacterial composition of the implants(Right after decontamination and implant removal (T0))
- Incidence of complications(Right after decontamination and implant removal (T0))
- Biocompatibility analysis of the implant(Right after decontamination and implant removal (T0))
- Scanning electron microscopy analysis of the cells and residual bacterial deposits(Right after decontamination and implant removal (T0))
- Patient satisfaction with the decontamination devices(Right after decontamination and implant removal (T0))
- Implant surface degradation(Right after decontamination and implant removal (T0))
- Corrosion performance(Right after decontamination and implant removal (T0))
- Atomic composition of the implants after removal(Right after decontamination and implant removal (T0))
研究者
Andrea Ravida
Assistant Professor
University of Pittsburgh