Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants

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.

Conditions

• Periimplant Diseases
• Dental Implant Failure
• Dental Implant Complications

Interventions

DEVICE

Laser 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

DEVICE

GalvoSurge 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

DRUG

0.2% 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)

PROCEDURE

Guided 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)

Sponsors & Collaborators

• University of Zagreb

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2027-03-01

Completion

2027-06-01

Countries

• Croatia

Study Locations