What is this study trying to find out about peri-implantitis?

This study is comparing two different surgical treatments for peri-implantitis to see how well they work over one year. Researchers will evaluate clinical, radiographic, and microbiological results, including patient satisfaction. The National and Kapodistrian University of Athens is leading this study to improve treatment approaches for this dental implant condition.

Who may be eligible for this peri-implantitis clinical trial?

Adults aged 18 to 80 years with at least one dental implant in function for more than one year may be eligible. Participants must be non-smokers and have implants diagnosed with peri-implantitis or healthy implants. People with uncontrolled diabetes or certain medications may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this peri-implantitis clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

Healthy Volunteers

ID05899933

Comparing Two Surgical Treatments for Peri-implantitis Using Implantoplasty or Erythritol Air-abrasive Device A 12-Month Clinical, Radiographic, and Microbiological Study

Led by National and Kapodistrian University of Athens · Updated on 2026-04-15

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are comparing two surgical methods to treat peri-implantitis, a condition affecting dental implants, by looking at clinical, X-ray, and microbiological results over one year. They also aim to analyze and compare bacteria in implants with peri-implantitis and healthy implants. This is a randomized controlled clinical study led by the National and Kapodistrian University of Athens. Participants first receive non-surgical peri-implant therapy. Six weeks later, if certain conditions are met, they undergo one of two types of surgical treatment either implantoplasty, which smooths the implant surface, or implant surface cleaning using an air-abrasive device with erythritol powder. Healthy implants are included as a comparison group for microbiological analysis. Follow-up treatments include professional cleaning at various intervals up to 12 months. During the study, participants have regular assessments including probing pocket depth, bleeding, suppuration, bone loss via X-rays, and microbiological tests at set intervals from baseline through 12 months post-surgery. Pain, swelling, and patient satisfaction are also evaluated. The main outcomes focus on treatment success defined by specific clinical and radiographic criteria at 12 months. The study follows participants up to one year after surgery to monitor these measures.

CONDITIONS

Brief Title

Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis

Who Can Participate

Age: 18Years - 80Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Participants aged 18 to 80 years
Non-smokers or those who quit smoking at least 2 years ago
Implants in function for more than 1 year after suprastructure connection
For peri-implantitis group: at least one implant with bleeding on probing and/or suppuration, probing pocket depth 66 mm, and 63 mm bone loss after initial remodeling
No implant mobility
For healthy implant group: absence of inflammation signs, no bleeding on probing, and bone loss not exceeding 2 mm beyond initial remodeling

You will not qualify if you...

Current smokers
Uncontrolled diabetes mellitus with HbA1c above 7
Treatment with bisphosphonates
Need for antibiotic prophylaxis
Pregnant or breastfeeding women
Antibiotic treatment within the last 3 months
Systemic conditions that contraindicate treatment
Use of medications causing gingival hyperplasia

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Non-surgical Peri-implant Therapy

Duration - 6 weeks

Participants receive non-surgical therapy including oral hygiene instruction, professional cleaning of implants and teeth, and possible adjustments to implant-borne prostheses. This occurs 2 weeks after baseline examination, followed by a re-evaluation at 6 weeks to determine eligibility for surgical therapy.

2 visits (baseline and 6-week re-evaluation)

Surgery

Duration - 1 day

Participants with peri-implant probing pocket depth ≥ 5 mm and signs of inflammation at 6-week re-evaluation undergo surgical therapy. This includes removal of supraconstructions, local anesthesia, flap elevation, granulation tissue removal, implant surface treatment with either Implantoplasty or Erythritol Air-abrasive device depending on group assignment, osseous recontouring if needed, and suturing for non-submerged healing. Supraconstructions are reconnected after surgery.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 12 months post-surgery

Participants attend follow-up visits to monitor healing and receive professional supramucosal biofilm removal using an air-abrasive device. These visits include re-motivation and re-instruction on oral hygiene measures.

Visits at 2 weeks, 3, 6, 9, and 12 months after surgery for surgical groups; Control group visits at 2 weeks, 3, 6, 9, and 12 months after baseline