Immediate versus delayed surgical reconstruction for bone defects around dental implants

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

Adults with peri-implantitis and intra-bony defects will receive either simultaneous debridement and regeneration at the same visit (control) or a staged approach with initial decontamination followed by delayed guided bone regeneration (test). Both approaches use a compound allogenic bone graft mixture and a non-resorbable barrier membrane, and outcomes will be measured clinically, radiographically, histologically, volumetrically, microbiologically, and with patient-reported measures. Eligible participants are systemically healthy adults who maintain good oral hygiene, have an implant in function for at least one year, and present an intra-bony defect ≥3 mm deep and ≤4 mm wide. The trial aims to see if delayed regeneration leads to better hard-tissue fill and improved patient-centered outcomes compared with the conventional simultaneous procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Systemically healthy adults
* Age ≥ 18 years
* The patient must be able to perform good oral hygiene
* With at least one implant with either cement or a screw-retained prosthesis demonstrating a diagnosis of peri-implantitis at an implant in function for a minimum of 1 year with a prosthesis installed.
* In cases where previous radiographic records are available: presence of bleeding and/or suppuration on gentle probing, increased probing depth compared to previous examinations, and radiographic evidence of bone loss beyond initial crestal remodeling. (Berglundh 2018).
* In cases where baseline radiographs are not available: presence of PPD ≥6 mm with BOP and/or suppuration (SUP) and radiographically detectable marginal bone loss (MBL) exceeding 3 mm on an implant in function forfor at least 1 year (Berglundh 2018).
* Target implants have to also demonstrate the presence of a peri-implant intra-bony defect with a depth ≥3 mm and width ≤4 mm, as assessed on radiographs and confirmed intra-surgically. In addition, the bony defect should present with a minimum of two walls .

No implant mobility and no evidence of occlusal overload. In patients presenting with more than one implant meeting the inclusion criteria, a single implant will be randomly selected for inclusion in the study.

Exclusion Criteria:

* Short implants (≤ 6mm)
* Contraindications for undergoing oral surgery.
* Patients pregnant or attempting to get pregnant (self-reported), or nursing women.
* Untreated/active periodontitis, or other untreated acute infections at the surgical site.
* Untreated malignancies at the surgical site.
* Self-reported current smoking, or active tobacco chewing, or chronic vaping.
* Taking long-term (\>1yr) NSAID, prednisone or other anti-inflammatory prescription drugs
* Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia.
* Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation.
* Unable to give consent for participation.

Where it's running

• University of Michigan School of Dentistry
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Study coordinator: Purnima Kumar, DDS, PhD
• Email: kpurnima@umich.edu
• Phone: 17347632105

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

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

  This tests whether adding implantoplasty to resective surgery reduces inflammation and improves outcomes around dental implants in adults with peri-implantitis.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07550127

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.