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

Primary Purpose

Moderate to Advanced Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
locally-applied minocycline HCl (1 mg)
scaling and root planing (Sc/RP)
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Advanced Chronic Periodontitis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska, College of Dentistry
  • Creighton University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sc/RP with minocycline micropheres

Sc/RP alone

Arm Description

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 is the subgingival mechanical removal of calculus and diseased cementum from the tooth root

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 17, 2012
Last Updated
September 2, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01647282
Brief Title
Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Official Title
Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
December 1, 2015 (Actual)
Study Completion Date
December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Advanced Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sc/RP with minocycline micropheres
Arm Type
Experimental
Arm Description
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
Arm Title
Sc/RP alone
Arm Type
Active Comparator
Arm Description
Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root
Intervention Type
Drug
Intervention Name(s)
locally-applied minocycline HCl (1 mg)
Other Intervention Name(s)
Arestin (minocycline microspheres) 1 mg
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing (Sc/RP)
Primary Outcome Measure Information:
Title
Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy C Killeen, DDS, MS
Organizational Affiliation
UNMC College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska, College of Dentistry
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583
Country
United States
Facility Name
Creighton University School of Dentistry
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68102
Country
United States

12. IPD Sharing Statement

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

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