Two surgical treatments for peri-implantitis: implantoplasty versus mechanical debridement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site, parallel-arm randomized trial enrolls adults with peri-implantitis requiring resective surgery and randomly assigns them to resective surgery with implantoplasty or resective surgery with mechanical debridement only. Blood is collected before surgery, about 48 hours after, and at 2 weeks, and gingival tissue and peri-implant crevicular fluid are sampled at baseline and about 3 months for molecular and inflammatory analyses. Participants then enter a structured maintenance program with visits every three months from month 6 through month 60 to monitor clinical stability and implant health. Clinical outcomes and molecular markers will be compared between groups to see if one surgical approach yields lower inflammation and better long-term stability.

Why it matters

Who can join: the full rules

Inclusion Criteria

To be enrolled, the participant must met the following inclusion criteria:

1. Aged 18 or older.
2. In good general health, classified as ASA Physical Status I or II.
3. Diagnosed with peri-implantitis requiring resective surgical treatment, characterized by: Bleeding on probing (BOP) around dental implants. Probing pocket depths (PPD) greater than 6 mm. Implants in function for over 1 year with progressive bone loss exceeding 3 mm. Initial screening confirmed by panoramic radiographs, cone-beam computed tomography (CBCT), and clinical diagnosis.

To be enrolled in the maintenance phase, participants must meet clinical stability criteria at the time of enrollment:

* Probing depth (PD) ≤ 5 mm
* Bleeding on probing (BOP) ≤ 1 point
* Absence of suppuration (SOP)
* Absence of progressive bone loss compared to pre-treatment bone levels

Exclusion Criteria:

1. Patients with autoimmune or systemic inflammatory diseases (e.g., lupus, rheumatoid arthritis) that could alter immune cell profiles independent of local peri-implant inflammation.
2. Chronic use of systemic corticosteroids or immunosuppressants within the past 3 months.
3. Uncontrolled diabetes (HbA1c \> 7.5%) due to its potential impact on healing and immune response.
4. Active infection or antibiotic use in the 30 days prior to baseline sampling.
5. Pregnancy or breastfeeding.
6. Inability to undergo venipuncture or tolerate soft tissue biopsy.
7. Inability to attend the 3-month follow-up visit or comply with study protocol.
8. History of malignancy requiring systemic therapy within the past 5 years.

Where it's running

• University of Pittsburgh School of Dental Medicine
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Andrea Ravida, DDS, MS, PhD — University of Pittsburgh, Department of Periodontics and Oral Medicine.
• Study coordinator: Andrea Ravida, DDS, MS, PhD
• Email: andrearavida@pitt.edu
• Phone: 7347309678

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How Smoking Affects Immune Responses Around Dental Implants

  This study tests how smoking changes the body's immune response around dental implants in people with healthy implants, peri-implant mucositis, or peri-implantitis.

  Recruiting Gazi University · Ankara, Ankara · NCT07750171

• AmbiJet-assisted treatment for inflamed dental implants

  This study tests whether applying cold atmospheric plasma with the AmbiJet system after standard cleaning helps reduce inflammation around dental implants more quickly in adults with peri-implant mucositis or peri-implantitis.

  Recruiting Freiburger Medizintechnik GmbH · Romny · NCT07722715

• Non-surgical H42 treatment for peri-implant pockets

  This study tests whether H42 can help heal peri-implant pockets compared with no-H42 care in adults with 6–8 mm pockets.

  Recruiting Bioteck S.p.A. · Seville · NCT07680491

• Macrophage behavior around dental implants in health and peri-implantitis

  This study will test whether macrophage-related markers in tissue and fluids around dental implants differ between people with peri-implantitis and those with healthy implants, and whether smoking changes those markers.

  Recruiting Biruni University · Istanbul · NCT07569432

• Access to probing around dental implants

  This multicenter study tests whether limited access to peri-implant probing is linked to more bone loss around dental implants in adults with implants in use for at least three years.

  Recruiting at 9 sites Arrow Development · A Coruña, A Coruña and 8 other locations · NCT07557459

• Keratinized mucosa graft to support treatment of peri-implantitis

  This trial will try adding a free gingival graft to non-surgical peri-implantitis care to see if increasing keratinized mucosa helps patients with less than 2 mm of mid‑buccal keratinized tissue heal better.

  Recruiting Gazi University · Ankara · NCT07471386

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.