Clinical trial NCT01647282: Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Official title: Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate to Advanced Chronic Periodontitis
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months
timeFrame: 24 months
Secondary outcomes:
measure: Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.
timeFrame: 24 months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska, College of Dentistry
state: Nebraska
city: Omaha
country: United States
facility: Creighton University School of Dentistry
state: Nebraska
Study officials:
affiliation: UNMC College of Dentistry
name: Amy C Killeen, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: