Immediate versus delayed surgical reconstruction for bone defects around dental implants
Immediate Versus Delayed Surgical Reconstruction of Peri-implantitis Intra-bony Defects: A Parallel-arm, Assessor-blind, Randomized, Controlled Clinical Trial
This trial will test whether doing bone grafting and membrane placement right away or waiting and doing it after initial healing works better for adults with peri-implantitis-related intra-bony defects around dental implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07325747 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) in good general health who keep good oral hygiene, have an implant in function for at least one year with clinical peri-implantitis, and show an intra-bony defect at least 3 mm deep and no wider than 4 mm.
Not a fit: Patients with only mucositis (soft-tissue inflammation), very large or non-intrabony defects, poor oral hygiene, uncontrolled systemic disease, or who cannot attend follow-up visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the delayed approach could produce greater bone regeneration around implants and improve patient comfort and satisfaction after peri-implantitis surgery.
How similar studies have performed: Guided bone regeneration and grafting for peri-implant bone defects have shown moderate success in prior studies, but direct comparisons of immediate versus delayed reconstruction are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.