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Completed

NCT Number: NCT01647282

Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Nebraska, College of Dentistry, Lincoln, Nebraska, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of moderate-severe chronic periodontitis
  • attending regular periodontal maintenance visits at UNMC COD
  • one quadrant with at least one > 5 mm interproximal pocket and 3 posterior teeth

Exclusion criteria

  • systemic diseases which impact periodontal inflammation and bone turnover
  • drugs which significantly impact periodontal inflammation and bone turnover
  • surgical periodontal therapy within the last year
  • pregnant or breast-feeding females

Treatment and study plan

locally-applied minocycline HCl (1 mg)

Drug

Other names: Arestin (minocycline microspheres) 1 mg

scaling and root planing (Sc/RP)

Procedure

Primary outcomes

  1. Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months

    Time frame: 24 months

    Changes in interproximal bone height loss were measured over the course of 24 months in two groups; patients receiving scaling and root planing alone in a deep periodontal pocket and those receiving scaling and root planing as well as minocycline microspheres in a deep periodontal pocket. These changes in interproximal bone height loss (mm) were determined via bitewing radiographs taken at baseline and 24 months and measured as distance from the cemento-enamel junction to the alveolar bone. Changes in probing depth (mm) were measured from the gingival margin to the depth of periodontal pocket. Changes in clinical attachment level (mm) were determined by adding the measure of gingival recession and the probing depth.

Secondary outcomes

  1. Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.

    Time frame: 24 months

    The gingival crevicular fluid is analyzed biochemically and the levels of inflammatory biomarkers can be determined. Specific biomarkers are inherent in periodontal disease and have been shown to be indicative of periodontal breakdown within a pocket. In this study, the biomarker, IL-1 were assessed for their presence and quantity within the GCF samples taken from the experimental periodontal pockets at baseline and 24 months.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2012
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.