Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Moderate to Advanced Chronic Periodontitis |
Drug: locally-applied minocycline HCl (1 mg) Procedure: scaling and root planing (Sc/RP) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients |
- Interproximal bone height loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Interproximal Bone Loss [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- presence of inflammatory biomarkers [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sc/RP with minocycline micropheres
Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root. Local application of minocycline microspheres will be done after scaling and root planing (Sc/RP) has been completed
|
Drug: locally-applied minocycline HCl (1 mg)
Other Name: Arestin (minocycline microspheres) 1 mg
Procedure: scaling and root planing (Sc/RP)
|
|
Active Comparator: Sc/RP alone
Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root
|
Procedure: scaling and root planing (Sc/RP) |
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| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Amy C Killeen, DDS, MS | 402-472-1441 | akilleen@unmc.edu |
| United States, Nebraska | |
| University of Nebraska College of Dentistry | |
| Lincoln, Nebraska, United States, 68583 | |
| Creighton University School of Dentistry | |
| Omaha, Nebraska, United States | |
| Principal Investigator: | Amy C Killeen, DDS, MS | UNMC College of Dentistry |
More Information
No publications provided
| Responsible Party: | Amy C. Killeen, DDS, MS, Assistant Professor, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT01647282 History of Changes |
| Other Study ID Numbers: | 314-12-FB |
| Study First Received: | July 17, 2012 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Inflammation Periodontitis Chronic Periodontitis Pathologic Processes Periodontal Diseases Mouth Diseases |
Stomatognathic Diseases Minocycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013