Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Condition: Moderate to Advanced Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of local application of minocycline
      microspheres on the periodontal inflammation and bone loss prevention in patients diagnosed
      with moderate-severe chronic periodontitis within a periodontal maintenance program.
    

Detailed description: 
      The over-arching goal of this application is to initiate a program to involve undergraduate
      dental students and their patients in clinical research to evaluate the efficacy of dental
      therapy. Specifically, the purpose of this study is to determine the effect of local
      application of minocycline microspheres on the periodontal inflammation and bone loss
      prevention in patients diagnosed with moderate-severe chronic periodontitis on periodontal
      maintenance in the undergraduate clinic. Few studies evaluating locally-applied minocycline
      during periodontal maintenance therapy have been reported even though the drug is commonly
      used in this protocol. A 6-month treatment study by Meinberg et al. (2002), demonstrated that
      in moderate-to-advanced chronic periodontitis patients, scaling and root planing with
      subgingival minocycline resulted in improved pocket depths and less frequent bone height loss
      over one year than conventional periodontal maintenance. The prevention of bone loss and
      inflammation is key to maintaining teeth in function and comfort for the patient's lifetime.
      Patients from the UNMC College of Dentistry (and eventually Creighton University School of
      Dentistry) undergraduate periodontal clinic, who are already enrolled in periodontal
      maintenance therapy, will be recruited to participate in this study. The selected patients
      will continue their periodontal maintenance care but will be placed into either the test
      group (receiving minocycline in a periodontally inflamed pocket along with subgingival
      mechanical debridement) or the control group (receiving subgingival mechanical debridement
      alone). Radiographs will be taken at baseline and at the study's completion (24 months) to
      obtain bone loss data, and periodontal measurements and gingival crevicular fluid (GCF) will
      be used to monitor markers of inflammation and bone resorption. The hypothesis to be tested
      in this clinical trial is that the use of minocycline at baseline and 6 month intervals in
      conjunction with subgingival mechanical debridement will reduce interproximal bone height
      loss and periodontal inflammation more than mechanical debridement alone.
    

Intervention name(s): locally-applied minocycline HCl (1 mg); scaling and root planing (Sc/RP)
Intervention type(s): Drug; Procedure
Other intervention name(s): Arestin (minocycline microspheres) 1 mg
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment