Effect of Locally-Applied Simvastatin on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Intervention: Methylcellulose; Simvastatin-Methylcellulose
Intervention description: Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.; Simvastatin-Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
Intervention MeSH terms: Simvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

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 methylcellulose gel alone.
      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age 40-85 years,

          2. diagnosis of chronic advanced adult periodontitis,

          3. one quadrant with at least one 6-9 mm interproximal pocket,

          4. overall good systemic health,

          5. willingness to sign consent form.

        Exclusion Criteria:

          1. systemic diseases which significantly impact periodontal inflammation and bone
             turnover (e.g. rheumatoid arthritis),

          2. taking drugs which significantly impact periodontal inflammation and bone turnover
             (e.g. chronic use of steroids or non-steroidal anti-inflammatory drug (>325 mg/d),
             estrogens, bisphosphonates, calcitonin, methotrexate),

          3. surgical periodontal therapy within the past year,

          4. pregnant or breast-feeding females.