Actively Recruiting

Phase Not Applicable
All Genders
NCT07529444

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

Led by University of Zagreb · Updated on 2026-04-14

90

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have at least one bone-level dental implant affected by peri-implantitis
  • Implant must be considered viable for preservation in the dental arch
  • Must be a non-smoker
  • Be in good general health classified as ASA I or ASA II according to the American Society of Anesthesiologists
Not Eligible

You will not qualify if you...

  • Presence of vertical bone loss around the affected implant
  • Implants that are not bone-level (e.g., tissue-level implants)
  • Having any systemic comorbidities
  • Currently smoking
  • Implants with a poor prognosis that cannot be preserved in the dental arch

AI-Screening

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Trial Site Locations

Total: 1 location

1

School of Dental Medicine

Zagreb, Croatia, 10000

Actively Recruiting

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Research Team

I

Igor Smojver, DMD;PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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