Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Zagreb
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Systemically healthy patients classified as ASA I (no systemic comorbidities).
Patients who are non-smokers.
Clinical diagnosis of peri-implantitis on a single dental implant per patient.
Implant morphology classified as Monje Class Ia (buccal dehiscence with <1mm horizontal bone loss) or Monje Class Ib (2-to-3-wall infrabony defect).
Disqualifiers
Patients with any systemic comorbidities or those not classified as ASA I.
Patients who are currently smokers.
Presence of more than one implant affected by peri-implantitis in the same patient.
Implants featuring any surface morphology other than SLA (e.g., machined, hydroxyapatite-coated) in the treated subcrestal area.
Trial design
Design model
Parallel
Treatments tested in this trial
Laser Photodynamic Therapy (PDT)
DeviceAntimicrobial photodynamic therapy applied to the contaminated implant surface. This involves the application of a riboflavin photosensitizer which is then activated by a blue laser to generate reactive oxygen species and eliminate bacterial biofilm. The procedure is concluded with a sterile normal saline rinse. Arm Group(s): Laser PDT + Saline Rinse
GalvoSurge Electrolytic Cleaning
DeviceDecontamination of the implant surface using the GalvoSurge dental device. This system utilizes an electrolytic process with a specific cleaning solution to actively lift and detach the bacterial biofilm from the rough titanium surface. The procedure is concluded with a sterile normal saline rinse. Arm Group(s): GalvoSurge + Saline Rinse
0.2% Chlorhexidine Gluconate
DrugChemical decontamination of the implant surface by rinsing it thoroughly with a 0.2% chlorhexidine gluconate solution, which serves as the active control/gold standard for antimicrobial reduction. Arm Group(s): Chlorhexidine Rinse (Control)
Guided Bone Regeneration (GBR)
Procedure/SurgeryA classic surgical bone grafting procedure performed on all implants immediately following their assigned decontamination protocol. The procedure involves placing a mixture of autologous bone particles and a xenograft around the implant, which is then covered by a collagen membrane fixed in place using titanium pins. Arm Group(s): Laser PDT + Saline Rinse; GalvoSurge + Saline Rinse; Chlorhexidine Rinse (Control)
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Laser PDT + Saline RinseExperimental treatment 2 interventions
Group B: GalvoSurge + Saline RinseExperimental treatment 2 interventions
Group C: Chlorhexidine Rinse (Control)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Microbiological Load of Periodontopathogenic Bacteria
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.
Time frame
Intraoperatively: Measured immediately before the decontamination procedure (baseline) and immediately after the completion of the decontamination procedure (prior to bone regeneration).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov