Phase 4
N=60
Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Moderate to Advanced Chronic Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT01647282 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months — 3.78; 3.87; 3.57; 3.8 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- locally-applied minocycline HCl (1 mg) (Drug); scaling and root planing (Sc/RP) (Procedure)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months |
3.78; 3.87; 3.57; 3.8; 5.29; 5.48 | — |
| SECONDARY Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1. |
9.29; 9.95; 10.30; 10.53 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01647282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.