Comparing two surgical methods for treating peri-implantitis

Implantoplasty Versus Implant Decontamination With Erythritol Air-abrasive Device During Surgical Therapy of Peri-implantitis. Clinical, Radiographic and Microbiological Evaluation. A Randomized Controlled Clinical Study

This study is testing two different surgical methods to see which one works better for treating peri-implantitis in patients with dental implants.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: National and Kapodistrian University of Athens (other)
• Locations: 1 site (Athens)
• Trial ID: NCT05899933 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of two different surgical protocols for treating peri-implantitis over a one-year period. It will assess clinical, radiographic, and microbiological outcomes, as well as patient satisfaction following treatment. The study will also compare microbiological results between implants diagnosed with peri-implantitis and healthy implants. Participants will undergo either implantoplasty or treatment with an erythritol air-abrasive device as part of their intervention.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with at least one implant diagnosed with peri-implantitis or healthy implants.

Not a fit: Patients with implant mobility or those who smoke may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from peri-implantitis.

How similar studies have performed: Previous studies have shown varying degrees of success with surgical interventions for peri-implantitis, but this specific comparison of methods is relatively novel.

Eligibility criteria

Inclusion Criteria:

General Inclusion Criteria:

* Participants ≥ 18 years and ≤ 80 years of age
* Non-smokers based on the patients' self-reported smoking status, defined as patients who had never smoked or had quit smoking at least 2 years ago
* Implants in function for more than 1 year after suprastructure connection

Inclusion Criteria for implants diagnosed with Peri-Implantitis:

* Presence of at least one implant diagnosed with peri-implantitis defined as presence of bleeding on probing and/or suppuration, probing pocket depth ≥6 mm and ≥3 mm of detectable bone loss after initial re-modelling
* Absence of implant mobility

  * in participants with more than one implant, the implant with the worst clinical condition will be studied.

Inclusion Criteria for implants diagnosed with Peri-Implant Health:

* Absence of peri-implant signs of inflammation (redness, swelling)
* Lack of bleeding on probing
* Absence of bone loss beyond crestal bone level changes resulting from initial remodeling, which should not be ≥2 mm

Exclusion Criteria:

* Smokers
* Uncontrolled diabetes mellitus (HBA1c \>7)
* Treatment with bisphosphonates
* Needing antibiotic prophylaxis
* Currently pregnant or breast-feeding women
* History of systemic administration of antibiotic treatment during the preceding 3 months
* Systemic conditions that contraindicate treatment
* Use of medications known to induce gingival hyperplasia

Where this trial is running

Athens

• Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens — Athens, Greece (RECRUITING)

Study contacts

• Study coordinator: Yiorgos A. Bobetsis, Assistant Professor

Conditions: Peri-Implantitis, Peri-Implant Health, Surgical therapy, Implantoplasty, Air-abrasive device, Erythritol powder, Peri-Implant microbiota