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

Moderate to Advanced Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647282
• Other study ID #: 0314-12-FB
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2012
• Est. completion date: December 1, 2015

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Inflammation
• Moderate to Advanced Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• locally-applied minocycline HCl (1 mg)

Procedure:
• scaling and root planing (Sc/RP)

Locations

Country	Name	City	State
United States	University of Nebraska, College of Dentistry	Lincoln	Nebraska
United States	Creighton University School of Dentistry	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 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.	24 months
Secondary	Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.	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.	24 months