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Phase 4 N=60 Randomized Single-blind Treatment

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

Moderate to Advanced Chronic Periodontitis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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