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

Phase 4

Completed

Conditions: Moderate to Advanced Chronic Periodontitis

Interventions: Procedure: scaling and root planing (Sc/RP)
Drug: locally-applied minocycline HCl (1 mg)

Registration Number: NCT01647282

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sc/RP alone	scaling and root planing (Sc/RP)	Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root
Sc/RP with minocycline micropheres	scaling and root planing (Sc/RP)	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
Sc/RP with minocycline micropheres	locally-applied minocycline HCl (1 mg)	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

Primary Outcome Measures

Name	Time	Method
Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months	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

Name	Time	Method
Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.	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.

Trial Locations

Locations (2): University of Nebraska, College of Dentistry
🇺🇸
Lincoln, Nebraska, United States
Creighton University School of Dentistry
🇺🇸
Omaha, Nebraska, United States