Comparing ways to clean infected dental implants
Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants Using the Polymerase Chain Reaction Method
NA · University of Zagreb · NCT07529444
This will test three different cleaning methods to remove bacterial biofilm from bone-level dental implants in healthy, non-smoking adults with peri-implantitis and no vertical bone loss.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | University of Zagreb (other) |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT07529444 on ClinicalTrials.gov |
What this trial studies
Ninety healthy, non-smoking participants with bone-level implants affected by peri-implantitis (but without vertical bone loss) will be randomized to one of three surgical decontamination approaches with 30 implants per group. One group receives photodynamic therapy with a blue laser and riboflavin followed by saline rinse, a second group receives electrolytic cleaning using the GalvoSurge system, and a third group receives chlorhexidine-based decontamination with surgical management including guided bone regeneration as indicated. Microbiological samples will be taken to compare bacterial load and species before and after treatment to determine which method most effectively removes the biofilm. Clinical follow-up will monitor healing, implant stability, and signs of recurrence.
Who should consider this trial
Good fit: Ideal participants are non-smoking adults in good general health (ASA I–II) who have at least one viable bone-level implant with peri-implantitis but without vertical bone loss.
Not a fit: Patients with vertical bone loss, tissue-level implants, systemic comorbidities, current smokers, or implants judged unsalvageable are unlikely to benefit from the methods tested here.
Why it matters
Potential benefit: If successful, the most effective cleaning method could improve the chances of preserving infected implants and lower the risk of recurrent peri-implant infection.
How similar studies have performed: Prior small studies of photodynamic therapy and electrolytic cleaning have produced promising but mixed results, so this work builds on preliminary evidence rather than on definitive prior success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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.
Where this trial is running
Zagreb
- School of Dental Medicine — Zagreb, Croatia (RECRUITING)
Study contacts
- Study coordinator: Igor Smojver, DMD;PhD
- Email: ismojver@sfzg.hr
- Phone: 385981651932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periimplant Diseases, Dental Implant Failure, Dental Implant Complications, peri-implantitis, implant decontamination, PDT, electrolytic cleaning, GalvoSurge