Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of using a synthetic bone substitute with or
      without simvastatin on regenerative surgical treatment of bone defects associated with
      peri-implantitis in a 6- months randomized controlled clinical trial.

      A total of 30 patients diagnosed with peri-implantitis were randomly assigned to one of two
      surgical treatment groups (group I: synthetic bone substitute (NanoBone), group II: NanoBone
      with simvastatin). Clinical measurements included probing pocket depth (PPD), clinical
      attachment level (CAL), plaque index (PI), modified sulcus bleeding index (mSBI) and mucosal
      recession (MR). Radiographic bone fill was evaluated at baseline and after 6- months.
    

Detailed description: 
      The study was designed as a prospective single-center, parallel group, 6 month randomized
      clinical trial evaluating the effect of a bone substitute; NanoBone® (Artoss GmbH, Rostock,
      Germany) (group 1, control group) compared to the same bone substitute with simvastatin
      (Corvast 80 mg, Egyphar, Egypt) (group 2, test group) for RST of peri-implantitis. A total of
      30 patients suffering from peri-implantitis who needed regenerative treatment of at least one
      peri-implant bone defect were selected and only one implant per patient (the most severe) was
      evaluated in the treatment groups. The criteria for diagnosing peri-implantitis is based on
      the consensus report of the eighth European Workshop on Periodontology [34] ; the presence of
      a peri-implant marginal bone loss ≥2 mm based on baseline periapical radiographs after
      delivery of the final restoration and bleeding on probing (BOP) and/or suppuration with or
      without concomitant deepening of peri-implant pockets.

      Clinical and radiographic evaluation were conducted at baseline and 6 months postoperatively.
      Grouping was done using a random number table generated by a third party. They were numbered
      according to the order of enrolment and assigned to group I or group II. The grouping results
      were sealed in an opaque envelope and kept by an independent third party. For each patient,
      cards opened immediately before the surgical procedures. Treatment assignment in each patient
      was registered by the clinician who assisted in the operations and kept concealed until the
      completion of the study.
    

Intervention name(s): bone substitute; NanoBone®
Intervention type(s): Other
Intervention description(s): surgical treatment of peri-implantitis using a regenerative surgical protocol utilizing NanoBone (NB) synthetic bone graft with or without simvastatin.
Other intervention name(s): simvastatin
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, parallel group, 6 month randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental implant; peri-implantitis; surgical treatment