Moderate to Advanced Chronic Periodontitis
Conditions
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.
Interventions
DRUGlocally-applied minocycline HCl (1 mg)
PROCEDUREscaling and root planing (Sc/RP)
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 23 |
| 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) | 25 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 7 | 5 |
Baseline characteristics
| Characteristic | Sc/RP Alone | Total | Sc/RP With Minocycline Micropheres |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 48 Participants | 23 Participants |
| Age, Continuous | 66.8 years STANDARD_DEVIATION 12.1 | 67.1 years STANDARD_DEVIATION 11 | 67.3 years STANDARD_DEVIATION 10.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 participants | 48 participants | 23 participants |
| Sex: Female, Male Female | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Male | 16 Participants | 30 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 |
| other Total, other adverse events | 0 / 23 | 0 / 25 |
| serious Total, serious adverse events | 0 / 23 | 0 / 25 |
Outcome results
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sc/RP With Minocycline Micropheres | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Interproximal Bone Loss 24 Months | 3.57 mm | Standard Deviation 1.45 |
| Sc/RP With Minocycline Micropheres | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Interproximal Bone Loss Baseline | 3.78 mm | Standard Deviation 1.43 |
| Sc/RP With Minocycline Micropheres | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Clinical Attachment Level - Baseline | 5.42 mm | Standard Deviation 0.65 |
| Sc/RP With Minocycline Micropheres | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Probing Depth - Baseline | 5.29 mm | Standard Deviation 0.62 |
| Sc/RP With Minocycline Micropheres | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Clinical Attachment Level - 24 Months | 5.81 mm | Standard Deviation 0.92 |
| Sc/RP With Minocycline Micropheres | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Probing Depth - 24 Months | 4.14 mm | Standard Deviation 0.89 |
| Sc/RP Alone | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Clinical Attachment Level - 24 Months | 4.24 mm | Standard Deviation 0.66 |
| Sc/RP Alone | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Interproximal Bone Loss Baseline | 3.87 mm | Standard Deviation 1.11 |
| Sc/RP Alone | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Interproximal Bone Loss 24 Months | 3.8 mm | Standard Deviation 1.13 |
| Sc/RP Alone | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Probing Depth - Baseline | 5.48 mm | Standard Deviation 0.75 |
| Sc/RP Alone | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Probing Depth - 24 Months | 3.96 mm | Standard Deviation 0.73 |
| Sc/RP Alone | Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months | Clinical Attachment Level - Baseline | 4.36 mm | Standard Deviation 1.05 |
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sc/RP With Minocycline Micropheres | Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1. | Gingival Crevicular Fluid - 24 months | 10.30 picograms/mL | Standard Deviation 2.21 |
| Sc/RP With Minocycline Micropheres | Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1. | Gingival Crevicular Fluid - Baseline | 9.29 picograms/mL | Standard Deviation 2.12 |
| Sc/RP Alone | Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1. | Gingival Crevicular Fluid - Baseline | 9.95 picograms/mL | Standard Deviation 1.98 |
| Sc/RP Alone | Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1. | Gingival Crevicular Fluid - 24 months | 10.53 picograms/mL | Standard Deviation 2.16 |