Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants Using the Polymerase Chain Reaction Method
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Microbiological Load of Periodontopathogenic Bacteria
研究概览
简要总结
The purpose of this prospective clinical study is to evaluate and compare the effectiveness of different cleaning (decontamination) methods for dental implants affected by peri-implantitis. Peri-implantitis is an inflammatory condition caused by a bacterial biofilm on the implant surface, which can lead to bone loss and implant failure if left untreated. Because the rough surface and threads of implants make them difficult to clean, finding the most effective decontamination method is critical for saving the implant.
This study will include 90 healthy, non-smoking participants who have a bone-level dental implant affected by peri-implantitis without vertical bone loss. Participants will be randomly assigned to one of three treatment groups (30 implants per group) to undergo a specific decontamination procedure during their surgical treatment:
Group 1 (Laser PDT): Decontamination using photodynamic therapy with a blue laser and riboflavin, followed by a sterile saline rinse.
Group 2 (GalvoSurge): Decontamination using an electrolytic cleaning device, followed by a sterile saline rinse.
Group 3 (Active Control): Decontamination using a 0.2% chlorhexidine gluconate rinse, which is the current standard of care.
To measure the effectiveness of these treatments, researchers will take sterile swabs from the implant surface immediately before and after the decontamination process. These swabs will be analyzed using PCR to detect changes in the microbiological load of five specific bacteria known to cause gum and implant disease (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythia).
Following the decontamination and swabbing, all participants will receive a standard Guided Bone Regeneration (GBR) procedure using autogenous bone, a xenograft, and a collagen membrane to help rebuild the bone around the implant.
By comparing the microbiological results before and after treatment, the study aims to determine whether the newer methods (Laser PDT or electrolytic cleaning) are more effective at removing harmful bacteria than the traditional chlorhexidine rinse prior to bone regeneration.
详细描述
Background and Rationale Contemporary dental implantology represents a reliable and predictable treatment method for partial or complete tooth loss. However, despite high success rates, complications such as peri-implantitis can lead to implant loss, significantly impacting patients functionally, emotionally, and financially. Peri-implantitis is an inflammatory condition affecting the soft and hard tissues surrounding an osseointegrated dental implant, with a prevalence of approximately 20% among patients undergoing implant therapy.
The primary etiological factor for peri-implantitis is the formation of a bacterial biofilm on the exposed surface of the implant. Biofilm formation is a complex, multi-step process involving the colonization of bacteria from around the implants, natural teeth, and other areas of the oral cavity. The oral biofilm associated with peri-implantitis is characterized by high microbial diversity. While no single specific bacterium has been identified as exclusively present in peri-implantitis biofilms, the long-term presence of this biofilm stimulates a host immune response, leading to chronic inflammation and subsequent tissue destruction.
The Clinical Challenge One of the most demanding and critical tasks in the treatment of peri-implantitis is the complete removal of the biofilm and the prevention of its recurrence. The presence of deep peri-implant pockets, restricted access to all implant surfaces, and the inherently rough, threaded topography of dental implants make mechanical and chemical decontamination exceptionally challenging.
Traditionally, mechanical tools such as curettes, sonic and ultrasonic instruments, air-polishing devices, and rotating titanium or chitosan brushes have been utilized to remove hard and soft deposits. A key clinical requirement is to achieve this with minimal damage or alteration to the implant surface. To address this, chemical agents (e.g., sterile saline, hydrogen peroxide, citric acid, EDTA, phosphoric acid, and chlorhexidine gluconate) are often employed alongside mechanical methods.
Recently, novel modalities have emerged to minimize surface damage while maximizing antimicrobial efficacy:
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with at least one bone-level dental implant affected by peri-implantitis.
- •The affected implant must be deemed viable with a perspective for preservation/retention in the dental arch.
- •Patients must be non-smokers.
- •Patients in good general health, classified as ASA I (a normal healthy patient) or ASA II (a patient with mild systemic disease) according to the American Society of Anesthesiologists physical status classification system.
排除标准
- •Presence of vertical bone loss around the affected implant.
- •Implants that are not bone-level (e.g., tissue-level implants).
- •Patients with any systemic comorbidities.
- •Patients who are currently smokers.
- •Implants with a poor prognosis that cannot be preserved in the dental arch.
研究组 & 干预措施
Laser PDT + Saline Rinse
Implants in this group will undergo surface decontamination using Photodynamic Therapy (PDT). This involves the application of a riboflavin photosensitizer activated by a blue laser, followed by a rinse with sterile normal saline solution. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.
Interventions:
Device / Procedure: Laser Photodynamic Therapy (PDT)
Procedure: Guided Bone Regeneration (GBR)
干预措施: Laser Photodynamic Therapy (PDT) (Device)
Laser PDT + Saline Rinse
Implants in this group will undergo surface decontamination using Photodynamic Therapy (PDT). This involves the application of a riboflavin photosensitizer activated by a blue laser, followed by a rinse with sterile normal saline solution. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.
Interventions:
Device / Procedure: Laser Photodynamic Therapy (PDT)
Procedure: Guided Bone Regeneration (GBR)
干预措施: Guided Bone Regeneration (GBR) (Procedure)
GalvoSurge + Saline Rinse
Implants in this group will undergo surface decontamination using the GalvoSurge electrolytic cleaning system, followed by a rinse with sterile normal saline solution. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.
Interventions:
Device / Procedure: GalvoSurge Electrolytic Cleaning
Procedure: Guided Bone Regeneration (GBR)
干预措施: GalvoSurge Electrolytic Cleaning (Device)
GalvoSurge + Saline Rinse
Implants in this group will undergo surface decontamination using the GalvoSurge electrolytic cleaning system, followed by a rinse with sterile normal saline solution. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.
Interventions:
Device / Procedure: GalvoSurge Electrolytic Cleaning
Procedure: Guided Bone Regeneration (GBR)
干预措施: Guided Bone Regeneration (GBR) (Procedure)
Chlorhexidine Rinse (Control)
Implants in this control group will undergo surface decontamination using the current clinical gold standard, which is a 0.2% chlorhexidine gluconate rinse. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.
Interventions:
Drug / Procedure: 0.2% Chlorhexidine Gluconate Rinse
Procedure: Guided Bone Regeneration (GBR)
干预措施: 0.2% Chlorhexidine Gluconate (Drug)
Chlorhexidine Rinse (Control)
Implants in this control group will undergo surface decontamination using the current clinical gold standard, which is a 0.2% chlorhexidine gluconate rinse. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.
Interventions:
Drug / Procedure: 0.2% Chlorhexidine Gluconate Rinse
Procedure: Guided Bone Regeneration (GBR)
干预措施: Guided Bone Regeneration (GBR) (Procedure)
结局指标
主要结局
Change in Microbiological Load of Periodontopathogenic Bacteria
时间窗: Intraoperatively: Measured immediately before the decontamination procedure (baseline) and immediately after the completion of the decontamination procedure (prior to bone regeneration).
The primary outcome evaluates the effectiveness of the decontamination protocols by measuring the change in the bacterial load on the implant surface. Sterile swabs taken before and after the intervention are analyzed using a validated real-time Polymerase Chain Reaction (RT-PCR) method to detect five specific periodontopathogenic bacteria (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythia). The microbiological load is expressed as a semi-quantitative score (-, +, ++, +++), which is then numerically coded for statistical analysis. The primary measure is the calculated difference (change) between the post-treatment and baseline pre-treatment scores for each individual implant.
次要结局
未报告次要终点
研究者
Igor Smojver
Sinior assistant
University of Zagreb