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

RecruitingNAAges any - anyAllUniversity of Zagreb
NCT07529444 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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). * Dental implants of either "bone-level" or "tissue-level" design , featuring an exclusively SLA (Sandblasted, Large-grit, Acid-etched) surface in the subcrestal area requiring decontamination. * Implants deemed viable with a favorable perspective for long-term preservation in the dental arch. Exclusion Criteria : * 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. * Bone defect morphology that does not correspond to Monje Class Ia or Ib (e.g., severe horizontal or vertical bone loss outside these parameters). * Implants with a poor prognosis where extraction is indicated.
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What it tests

  • Laser Photodynamic Therapy (PDT)
  • GalvoSurge Electrolytic Cleaning
  • 0.2% Chlorhexidine Gluconate
  • Guided Bone Regeneration (GBR)
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Where

1 site
School of Dental Medicine
Zagreb, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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