Overview
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.
Description
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:
Antimicrobial Photodynamic Therapy (aPDT): Based on a photochemical reaction between a photosensitizer, oxygen, and a specific light wavelength, this therapy generates reactive oxygen species that induce bacterial cell death.
Electrolytic Cleaning (GalvoSurge): This method utilizes an electrolytic process to actively lift and eliminate bacterial biofilms from rough titanium surfaces, demonstrating promising in vitro results.
Study Objectives This prospective clinical trial is designed to evaluate and compare the antimicrobial efficacy of two novel implant decontamination protocols-Laser PDT and Electrolytic Cleaning (GalvoSurge)-against the widely accepted gold standard of 0.2% chlorhexidine gluconate rinsing. The primary focus is assessing the reduction of the microbiological load on the implant surface immediately following decontamination and prior to regenerative bone surgery.
Methodology and Clinical Protocol The study will be conducted at the School of Dental Medicine, University of Zagreb, within the Department of Oral Surgery. All surgical procedures will be performed by the same specialist in oral surgery to ensure procedural consistency.
The trial will enroll 90 bone-level dental implants affected by peri-implantitis but deemed viable for retention in the dental arch. Implants with vertical bone loss are excluded from this study. Eligible participants are restricted to healthy, non-smoking individuals classified as ASA I or II, with no systemic comorbidities. Pre-operative assessment will include Cone Beam Computed Tomography (CBCT) imaging.
The clinical workflow for each implant is as follows:
Flap Elevation: A mucoperiosteal flap is raised to expose the contaminated implant surface.
Baseline Sampling (Sample 1): A sterile swab is taken directly from the implant surface for initial PCR analysis to establish the baseline microbiological load.
Randomization and Intervention: Implants are randomly assigned to one of three treatment arms (n=30 per arm):
Group 1: Decontamination using Laser PDT (riboflavin photosensitizer + blue laser) followed by a sterile saline rinse.
Group 2: Decontamination using the GalvoSurge electrolytic system followed by a sterile saline rinse.
Group 3 (Active Control): Decontamination using a 0.2% chlorhexidine gluconate rinse.
Post-Treatment Sampling (Sample 2): Immediately following the decontamination protocol, a second sterile swab is taken for PCR analysis.
Regenerative Procedure: The surgery concludes with a classic Guided Bone Regeneration (GBR) procedure, utilizing autologous bone particles, a xenograft, and a collagen membrane fixed in place with titanium pins.
Microbiological Analysis
Samples will be analyzed using a validated real-time Polymerase Chain Reaction (RT-PCR) method targeting five specific periodontopathogenic bacteria:
Aggregatibacter actinomycetemcomitans
Porphyromonas gingivalis
Prevotella intermedia
Treponema denticola
Tannerella forsythia
The primary outcome is the change in the microbiological load. Results will be expressed as a semi-quantitative score (-, +, ++, +++), which will be numerically coded for statistical evaluation. The change is calculated as the difference between the post-treatment and pre-treatment values for each specific implant.
Sample Size and Statistical Analysis Plan The study is designed as a prospective comparative trial with repeated measures. Sample size estimations were based on available in vitro studies demonstrating a large effect size for electrolytic decontamination compared to standard methods.
Power Calculation: Assuming a conservative large standardized effect size (Cohen's d ≈ 0.9), a two-sided significance level of α = 0.05, and a test power of 80%, a minimum of 25 implants per group is required to detect statistically significant differences between the test groups and the control group. To account for potential sample loss or unusable swabs, the enrollment target was increased to 30 implants per group (90 implants total).
Data Analysis: Statistical significance is set at 95% (p \< 0.05). Normal distribution of the data will be assessed descriptively and via formal tests.
For normally distributed data, a one-way Analysis of Variance (ANOVA) will be utilized, followed by post-hoc comparisons of each test group against the control group.
If assumptions for parametric testing are not met, appropriate non-parametric alternatives will be applied.
Differences between baseline and post-treatment values within individual groups will be analyzed using tests for dependent samples.
Qualitative outcomes (e.g., the positive or negative presence of the target pathogens) will be evaluated using categorical data methodologies.
Hypothesis: Based on preliminary in vitro findings, the investigators anticipate a more pronounced therapeutic and antimicrobial effect in the GalvoSurge electrolytic cleaning group compared to the control.
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
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.
