RecruitingNot ApplicableNCT07529444

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 Using the Polymerase Chain Reaction Method


Sponsor

University of Zagreb

Enrollment

90 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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Interventions

DEVICELaser Photodynamic Therapy (PDT)

Antimicrobial 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

DEVICEGalvoSurge Electrolytic Cleaning

Decontamination 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

DRUG0.2% Chlorhexidine Gluconate

Chemical 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)

PROCEDUREGuided Bone Regeneration (GBR)

A 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)


Locations(1)

School of Dental Medicine

Zagreb, Croatia

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NCT07529444