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

Information source: University of Nebraska
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Moderate to Advanced Chronic Periodontitis

Intervention: locally-applied minocycline HCl (1 mg) (Drug); scaling and root planing (Sc/RP) (Procedure)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Nebraska

Official(s) and/or principal investigator(s):
Amy C Killeen, DDS, MS, Principal Investigator, Affiliation: UNMC College of Dentistry

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome:

Interproximal bone height loss

Interproximal Bone Loss

Secondary outcome: presence of inflammatory biomarkers

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.

Eligibility

Minimum age: 40 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Nebraska College of Dentistry, Lincoln, Nebraska 68583, United States

Creighton University School of Dentistry, Omaha, Nebraska, United States

Additional Information

Starting date: September 2012
Last updated: December 1, 2014

Page last updated: August 23, 2015

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