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Compares treatment options for Peri Implantitis
Official title Immediate Versus Delayed Surgical Reconstruction of Peri-implantitis Intra-bony Defects.
ClinicalTrials.gov ID: NCT07325747
What this study is testing
- What it's testing
- The purpose of this study is to test the comparative efficacy of two surgical approaches (immediate versus delayed GBR) for the surgical reconstruction of peri-implantitis intra-bony defects in terms of the clinical, radiographical, histological, volumetric, microbiological, and patient-reported outcomes. The investigators hypothesize that in certain clinical situations, treatment of peri-implantitis intra-bony defects with the use of a compound bone grafting material (mixture of allogenic bone substitutes) and a non-resorbable barrier membrane and following a delayed approach (test group) with initial phase of defect decontamination and initial healing phase would yield superior outcomes to that of the conventional approach (control group) of defect decontamination and regeneration at the same clinical visit while also significantly enhancing patient-reported outcomes: H0: There is no difference between the two mentioned approaches in terms of the treatment outcomes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- In cases where previous radiographic records are available: presence of bleeding and/or suppuration on gentle probing, increased probing depth...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- Unable to give consent for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.