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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Amy C. Killeen, DDS, MS, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01647282
First received: July 17, 2012
Last updated: July 20, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647282

Contacts
Contact: Amy C Killeen, DDS, MS 402-472-1441 akilleen@unmc.edu

Locations
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
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 August 28, 2014