44 Participants NeededMy employer runs this trial

Surgical Treatments for Peri-Implantitis

CS
AR
Overseen ByAndrea Ravida, DDS, MS, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of surgeries for peri-implantitis, a condition involving inflammation around dental implants. One group will undergo resective surgery with implantoplasty (implant polishing), while the other will receive resective surgery with mechanical debridement (thorough cleaning without polishing). The researchers aim to assess how these treatments affect inflammation and healing. The trial seeks participants who have had dental implants for over a year, exhibit inflammation with bleeding, and have experienced bone loss around their implants. As an unphased trial, participants can contribute to valuable research that may enhance future dental treatments.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using systemic corticosteroids, immunosuppressants, or antibiotics, you may not be eligible to participate.

What prior data suggests that these surgical treatments for peri-implantitis are safe?

Research has shown that both treatments in this study—resective surgery with implantoplasty and resective surgery with mechanical cleaning—are safe.

For resective surgery with implantoplasty, studies have found that dental implants remain durable over time. One study reported survival rates between 97.9% and 100% over several years, indicating that the treatment is generally safe and well-tolerated, with few long-term issues.

Resective surgery with mechanical cleaning has also undergone safety evaluation. Research indicates it effectively treats inflammation around dental implants, known as peri-implantitis, suggesting it is a safe choice for many patients.

Overall, both treatments have demonstrated safety with few side effects, making them good options for managing peri-implantitis.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for peri-implantitis because they offer innovative approaches to managing this challenging condition. Resective surgery with implantoplasty stands out by polishing titanium implant surfaces to reduce roughness and remove bacterial biofilm, potentially improving outcomes by minimizing the chances of future bacterial colonization. On the other hand, resective surgery with mechanical debridement uses submucosal air-polishing with a special powder, which could enhance cleaning effectiveness without the need for more invasive bone removal. These techniques aim to optimize healing and prevent further implant complications, offering promising alternatives to the standard of care, which often involves more conventional cleaning and decontamination methods.

What evidence suggests that this trial's surgical treatments could be effective for peri-implantitis?

This trial will compare two surgical treatments for peri-implantitis. Research has shown that both types of surgery can reduce inflammation and improve the area around dental implants affected by peri-implantitis. One treatment arm involves resective surgery with implantoplasty, which smooths the implant surface. This method has success rates between 66% and 79.5% in improving implant health, significantly reducing the space between the gum and implant, as well as bleeding and inflammation. The other treatment arm involves resective surgery with mechanical debridement, which cleans the implant surface without smoothing it. This method also effectively reduces signs of peri-implantitis, and studies suggest that with ongoing care, long-term improvement is possible in about 60% of cases. Both treatments are promising, but the best choice depends on the patient's specific needs and conditions.36789

Who Is on the Research Team?

AR

Andrea Ravida, DDS, MS, PhD

Principal Investigator

University of Pittsburgh, Department of Periodontics and Oral Medicine.

Are You a Good Fit for This Trial?

This trial is for adults 18 or older in good general health who have peri-implantitis around dental implants. Eligible participants must have deep gum pockets, bleeding on probing, and bone loss of more than 3 mm after at least one year with the implant.

Inclusion Criteria

I do not have any pus or signs of infection.
I am 18 years old or older.
* Absence of progressive bone loss compared to pre-treatment bone levels
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo resective surgery with either implantoplasty or mechanical debridement

3 months
3 visits (baseline, 48 hours post-surgery, 2 weeks post-surgery)

Treatment

Participants undergo resective surgery with either implantoplasty or mechanical debridement

Immediate (surgery day)
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with gingival tissue biopsy and peri-implant crevicular fluid collection

3 months
1 visit (3 months post-surgery)

Post-surgery Monitoring

Blood samples collected at 48 hours and 2 weeks post-surgery; gingival tissue and PICF collected at baseline and 3 months post-surgery

3 months
Multiple visits (in-person)

Maintenance

Participants are followed in a structured supportive care program with regular visits

54 months
Visits every 3 months from month 6 to month 60

Follow-up

Participants are monitored in a structured supportive care program with visits every 3 months

54 months
18 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Resective surgery with implantoplasty
  • Resective surgery with mechanical debridement

Trial Overview

The study compares two surgical treatments for peri-implantitis: resective surgery with implantoplasty versus resective surgery with mechanical cleaning only. Participants are randomly assigned to a group and followed for up to five years.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Resective surgery with implantoplastyExperimental Treatment1 Intervention
Group II: Resective surgery with mechanical debridementActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Citations

Peri-implantitis management by resective surgery combined ...

Free gingival graft (FGG) has been reported as an effective strategy to prevent gingival inflammation, mucosal recession, and crestal bone loss. In addition, ...

Resective surgical treatment of peri-implantitis

The resective surgical treatment of PI effectively reduced clinical parameters (PD, BoP, MBl, and inflammation) in the tissues affected by PI.

Resolution of peri‐implantitis by means of implantoplasty as ...

The overall therapeutic success rate at implant-level was 66% and 79.5% for case definition #1 and #2, respectively. APF group displayed more ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17348882/

Therapy of peri-implantitis with resective surgery. A 3-year ...

The results of this radiographic research suggested that implantoplasty was an effective treatment of peri-implant infections and peri-implantitis progression.

implantitis by means of implantoplasty as adjunct to surgical ...

The purpose of this study was to evaluate the resolution of peri-implantitis by means of implanto- plasty as adjunct to surgical resective (RES) ...

Implantoplasty Improves Clinical Parameters over a 2-Year ...

Medium- to long-term results after implantoplasty are rare, and survival rates range from 100% at 24 months [22] to 97.9% or 100% at 36 months [11,14] and 87.2% ...

Clinical Outcomes of Resective Surgical Treatment of Peri ...

The aims of the current study are 1) to assess the therapeutic resolution of the peri-implantitis after resective surgical treatment with or without ...

Efficacy of implantoplasty in the treatment of peri-implantitis

The survival and success rates of osseointegrated implants demonstrated safety and high rates of success, indicating minimal long-term marginal bone resorption ...

Long‐term surgical treatment outcomes of peri‐implantitis

Data suggest that the long-term disease resolution is ∼60% under supportive peri-implant care, while ∼70% exhibit progressive bone loss ...