Effect of Locally-Applied Simvastatin on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine of local application of commericially-available,
FDA-approved preparation of simvastatin is effective in increasing clinical attachment levels
(primary outcome), as well as alveolar bone (secondary outcome) compared to standard
mechanical therapy in patients on periodontal maintenance therapy (PMT). Subjects undergoing
PMT at the UNMC College of Dentistry clinics will be recruited to participate in the
randomized one-year clinical trial based on the following eligibility criteria: 1) diagnosis
of chronic advanced periodontitis (generalized or localized), 2) participating in regular PMT
visits (3-6) month intervals), 3) no systemic diseases or medication which significantly
impact periodontal inflammation or bone turnover (e.g. steroids, bisphosphonates, > 325 mg
aspirin/day and in good general health, 4) one experimental quadrant of the mouth with an
inflamed 6-9 mm interproximal posterior periodontal pocket with history of bleeding on
probing (BOP), 5) willingness to sign consent form. Subjects will be divided into two groups
for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local
anesthesia and mini-flap reflection with subgingival mechanical debridement plus application
of the simvastatin-methylcellulose gel or 2) local anesthesia and mini-flap reflection with
subgingival mechanical debridement plus application of saline. Samples/measurement will be
obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during
PMT: 1) digital radiographs (baseline and 12 months only; bone height measurements), 2)
presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid
(GCF) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel
junction, 5) probing pocket depth and bleeding on probing (BOP). Following the 12-month
visit, the research-specific intervention and measurements in the experiment quadrant will be
removed from routine PMT.