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 lossInterproximal 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
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