Trial Outcomes & Findings for Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients (NCT NCT01647282)
NCT ID: NCT01647282
Last Updated: 2023-09-25
Results Overview
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.
COMPLETED
PHASE4
60 participants
24 months
2023-09-25
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Physician Decision
|
7
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sc/RP With Minocycline Micropheres
n=23 Participants
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 Alone
n=25 Participants
Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root
scaling and root planing (Sc/RP)
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=23 Participants
|
25 Participants
n=25 Participants
|
48 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=23 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=48 Participants
|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 10.5 • n=23 Participants
|
66.8 years
STANDARD_DEVIATION 12.1 • n=25 Participants
|
67.1 years
STANDARD_DEVIATION 11.0 • n=48 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=23 Participants
|
9 Participants
n=25 Participants
|
18 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=23 Participants
|
16 Participants
n=25 Participants
|
30 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
23 participants
n=23 Participants
|
25 participants
n=25 Participants
|
48 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Sc/RP With Minocycline Micropheres
n=23 Participants
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 Alone
n=25 Participants
Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root
scaling and root planing (Sc/RP)
|
|---|---|---|
|
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
|
3.87 mm
Standard Deviation 1.11
|
|
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
|
3.8 mm
Standard Deviation 1.13
|
|
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
|
5.48 mm
Standard Deviation 0.75
|
|
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
|
3.96 mm
Standard Deviation 0.73
|
|
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
|
4.36 mm
Standard Deviation 1.05
|
|
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
|
4.24 mm
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Sc/RP With Minocycline Micropheres
n=23 Participants
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 Alone
n=25 Participants
Sc/RP is the subgingival mechanical removal of calculus and diseased cementum from the tooth root
scaling and root planing (Sc/RP)
|
|---|---|---|
|
Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.
Gingival Crevicular Fluid - Baseline
|
9.29 picograms/mL
Standard Deviation 2.12
|
9.95 picograms/mL
Standard Deviation 1.98
|
|
Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.
Gingival Crevicular Fluid - 24 months
|
10.30 picograms/mL
Standard Deviation 2.21
|
10.53 picograms/mL
Standard Deviation 2.16
|
Adverse Events
Sc/RP With Minocycline Micropheres
Sc/RP Alone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place