- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647282
Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
September 2, 2023 updated by: University of Nebraska
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nebraska
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Lincoln, Nebraska, United States, 68583
- University of Nebraska, College of Dentistry
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Omaha, Nebraska, United States, 68102
- Creighton University School of Dentistry
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
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Other Names:
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Active Comparator: Sc/RP alone
Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy C Killeen, DDS, MS, UNMC College of Dentistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 17, 2012
First Submitted That Met QC Criteria
July 20, 2012
First Posted (Estimated)
July 23, 2012
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 2, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0314-12-FB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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