Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants
NCT: NCT07529444 · RECRUITING
Brief Summary
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.
Frequently Asked Questions
What is Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants?
Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants is a clinical trial registered under NCT07529444. Current status: RECRUITING.
What is the status of NCT07529444?
The current status of NCT07529444 (Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants) is: RECRUITING.
When did Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants start?
Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants started on 2026-03-01.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.