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

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ClinicalTrials.gov Identifier: NCT01647282
Recruitment Status : Completed
First Posted : July 23, 2012
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Amy C. Killeen, DDS, MS, University of Nebraska

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.

Condition or disease Intervention/treatment Phase
Moderate to Advanced Chronic Periodontitis Drug: locally-applied minocycline HCl (1 mg) Procedure: scaling and root planing (Sc/RP) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Study Start Date : September 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647282


Locations
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United States, Nebraska
University of Nebraska College of Dentistry
Lincoln, Nebraska, United States, 68583
Creighton University School of Dentistry
Omaha, Nebraska, United States
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Amy C Killeen, DDS, MS UNMC College of Dentistry

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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
First Posted: July 23, 2012    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Inflammation
Pathologic Processes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents