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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sc/RP with minocycline micropheres | Experimental | 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 alone | Active Comparator | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| locally-applied minocycline HCl (1 mg) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy C Killeen, DDS, MS | UNMC College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska, College of Dentistry | Lincoln | Nebraska | 68583 | United States | ||
| Creighton University School of Dentistry |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sc/RP With Minocycline Micropheres | 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) |
| FG001 | Sc/RP Alone | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sc/RP With Minocycline Micropheres | 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients included had moderate-severe chronic periodontitis with a >/= 5 mm interproximal, posterior pocket that bled upon probing. Participating patients had a history of regular periodontal maintenance therapy and no systemic disease (rheumatoid arthritis, osteoporosis, tetracycline allergy) or medications with bone-turnover significance. | Posted | Mean | Standard Deviation | mm | 24 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sc/RP With Minocycline Micropheres | 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy C. Killeen | UNMC College of Dentistry | 402-202-7848 | akilleen@unmc.edu |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| scaling and root planing (Sc/RP) | Procedure |
|
| 24 months |
| Omaha |
| Nebraska |
| 68102 |
| United States |
| Sc/RP Alone |
Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Sc/RP With Minocycline Micropheres | 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) |
| OG001 | Sc/RP Alone | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) |
|
|
| 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. | Patients included had moderate-severe chronic periodontitis with a >/= 5 mm interproximal, posterior pocket that bled upon probing. Participating patients had a history of regular periodontal maintenance therapy and no systemic disease (rheumatoid arthritis, osteoporosis, tetracycline allergy) or medications with bone-turnover significance. | Posted | Mean | Standard Deviation | picograms/mL | 24 months |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Sc/RP Alone | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) | 0 | 25 | 0 | 25 | 0 | 25 |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |