Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial.
O Carcuac, J Derks, G Charalampakis...
https://pubmed.ncbi.nlm.nih.gov/26285807Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID05899933
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
Led by National and Kapodistrian University of Athens · Updated on 2026-04-15
45
Participants Needed
1
Research Sites
N/A
Total Duration
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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
AI-Screening
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1
2
3
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
Trial Site Locations
Total: 1 location
1
Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens
Athens, Greece, 11527
Actively Recruiting
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Research Team
Y
Yiorgos A. Bobetsis, Assistant Professor
S
Sotiria Tsantila
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Identification of periodontal pathogens in healthy periimplant sites.
Priscila Ladeira Casado, Ivone Beatriz Otazu, Alex Balduino...
https://pubmed.ncbi.nlm.nih.gov/21613949Microbiome of peri-implant infections: lessons from conventional, molecular and metagenomic analyses.
Georgios Charalampakis, Georgios N Belibasakis
https://pubmed.ncbi.nlm.nih.gov/25654499A follow-up study of peri-implantitis cases after treatment.
Georgios Charalampakis, Per Rabe, Asa Leonhardt...
https://pubmed.ncbi.nlm.nih.gov/21770994Patient-specific analysis of periodontal and peri-implant microbiomes.
S M Dabdoub, A A Tsigarida, P S Kumar
https://pubmed.ncbi.nlm.nih.gov/24158341The therapy of peri-implantitis: a systematic review.
Lisa J A Heitz-Mayfield, Andrea Mombelli
https://pubmed.ncbi.nlm.nih.gov/24660207Implantoplasty Versus Glycine Air Abrasion for the Surgical Treatment of Peri-implantitis: A Randomized Clinical Trial.
Jérôme Frédéric Lasserre, Michel Christian Brecx, Selena Toma
https://pubmed.ncbi.nlm.nih.gov/31923303Short-term clinical and microbiological evaluations of peri-implant diseases before and after mechanical anti-infective therapies.
Maria Beatriz Máximo, Adriana Cutrim de Mendonça, Vanessa Renata Santos...
https://pubmed.ncbi.nlm.nih.gov/19126114The characteristics of biofilms in peri-implant disease.
Andrea Mombelli, Fabien Décaillet
https://pubmed.ncbi.nlm.nih.gov/21323716The Current Weight of Evidence of the Microbiologic Profile Associated With Peri-Implantitis: A Systematic Review.
Paula Juliana Pérez-Chaparro, Poliana Mendes Duarte, Jamil Awad Shibli...
https://pubmed.ncbi.nlm.nih.gov/27420109