Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: locally-applied minocycline HCl (1 mg)
Other Names:
Procedure: scaling and root planing (Sc/RP)
|
| Active Comparator: Sc/RP alone Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root |
Procedure: scaling and root planing (Sc/RP)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nebraska College of Dentistry | Lincoln | Nebraska | United States | 68583 |
| 2 | Creighton University School of Dentistry | Omaha | Nebraska | United States |
Sponsors and Collaborators
- University of Nebraska
Investigators
- Principal Investigator: Amy C Killeen, DDS, MS, UNMC College of Dentistry
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 314-12-FB
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Sc/RP With Minocycline Micropheres | Sc/RP Alone |
|---|---|---|
| Arm/Group 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) |
| Period Title: Overall Study | ||
| STARTED | 30 | 30 |
| COMPLETED | 23 | 25 |
| NOT COMPLETED | 7 | 5 |
Baseline Characteristics
| Arm/Group Title | Sc/RP With Minocycline Micropheres | Sc/RP Alone | Total |
|---|---|---|---|
| Arm/Group 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) | Total of all reporting groups |
| Overall Participants | 23 | 25 | 48 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
23
100%
|
25
100%
|
48
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
67.3
(10.5)
|
66.8
(12.1)
|
67.1
(11.0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
39.1%
|
9
36%
|
18
37.5%
|
| Male |
14
60.9%
|
16
64%
|
30
62.5%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| United States |
23
100%
|
25
100%
|
48
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Sc/RP With Minocycline Micropheres | Sc/RP Alone |
|---|---|---|
| Arm/Group 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) |
| Measure Participants | 23 | 25 |
| Interproximal Bone Loss Baseline |
3.78
(1.43)
|
3.87
(1.11)
|
| Interproximal Bone Loss 24 Months |
3.57
(1.45)
|
3.8
(1.13)
|
| Probing Depth - Baseline |
5.29
(0.62)
|
5.48
(0.75)
|
| Probing Depth - 24 Months |
4.14
(0.89)
|
3.96
(0.73)
|
| Clinical Attachment Level - Baseline |
5.42
(0.65)
|
4.36
(1.05)
|
| Clinical Attachment Level - 24 Months |
5.81
(0.92)
|
4.24
(0.66)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Sc/RP With Minocycline Micropheres | Sc/RP Alone |
|---|---|---|
| Arm/Group 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) |
| Measure Participants | 23 | 25 |
| Gingival Crevicular Fluid - Baseline |
9.29
(2.12)
|
9.95
(1.98)
|
| Gingival Crevicular Fluid - 24 months |
10.30
(2.21)
|
10.53
(2.16)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Sc/RP With Minocycline Micropheres | Sc/RP Alone | ||
| Arm/Group 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 locally-applied minocycline HCl (1 mg) scaling and root planing (Sc/RP) | Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root scaling and root planing (Sc/RP) | ||
All Cause Mortality |
||||
| Sc/RP With Minocycline Micropheres | Sc/RP Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/25 (0%) | ||
Serious Adverse Events |
||||
| Sc/RP With Minocycline Micropheres | Sc/RP Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/25 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Sc/RP With Minocycline Micropheres | Sc/RP Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/25 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Amy C. Killeen |
|---|---|
| Organization | UNMC College of Dentistry |
| Phone | 402-202-7848 |
| akilleen@unmc.edu |
- 314-12-FB