Trial Outcomes & Findings for Long-term Safety of Minocycline in Patients With Gum Disease (NCT NCT00668746)
NCT ID: NCT00668746
Last Updated: 2011-12-12
Results Overview
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
from Baseline to Day 30 and Day 180
Results posted on
2011-12-12
Participant Flow
Participant milestones
| Measure |
Minocycline HCl Microspheres
A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
|
No Drug Intervention
A control consisting of no drug intervention
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
12
|
|
Overall Study
COMPLETED
|
21
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Minocycline HCl Microspheres
A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
|
No Drug Intervention
A control consisting of no drug intervention
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Long-term Safety of Minocycline in Patients With Gum Disease
Baseline characteristics by cohort
| Measure |
Minocycline HCl Microspheres
n=23 Participants
A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
|
No Drug Intervention
n=12 Participants
A control consisting of no drug intervention
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.65 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
52.83 years
STANDARD_DEVIATION 9.90 • n=7 Participants
|
56.00 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
12 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from Baseline to Day 30 and Day 180Population: intention to treat (ITT)
Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.
Outcome measures
| Measure |
Minocycline HCl Microspheres
n=23 Participants
A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
|
No Drug Intervention
n=12 Participants
A control consisting of no drug intervention
|
Micocycline Group at 180 Days
|
Control Group at Baseline
|
Control Group at 30 Days
|
Control Group at 180 Days
|
|---|---|---|---|---|---|---|
|
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Plaque Sample at Day 180
|
8.09 Percentage Change
Standard Deviation 19.77
|
1.58 Percentage Change
Standard Deviation 2.49
|
—
|
—
|
—
|
—
|
|
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Saliva Sample at Day 180
|
12.06 Percentage Change
Standard Deviation 18.35
|
-0.51 Percentage Change
Standard Deviation 10.70
|
—
|
—
|
—
|
—
|
|
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Plaque Sample at Day 30
|
13.15 Percentage Change
Standard Deviation 19.77
|
0.81 Percentage Change
Standard Deviation 3.33
|
—
|
—
|
—
|
—
|
|
Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture
Saliva Sample at Day 30
|
37.65 Percentage Change
Standard Deviation 113.9
|
-2.25 Percentage Change
Standard Deviation 6.18
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 30 and Day 180Population: ITT
Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples
Outcome measures
| Measure |
Minocycline HCl Microspheres
n=23 Participants
A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
|
No Drug Intervention
n=23 Participants
A control consisting of no drug intervention
|
Micocycline Group at 180 Days
n=23 Participants
|
Control Group at Baseline
n=12 Participants
|
Control Group at 30 Days
n=12 Participants
|
Control Group at 180 Days
n=12 Participants
|
|---|---|---|---|---|---|---|
|
Micocycline-Resistance From Plaque Samples
R.dentocariosa
|
0.00 Percentage of Subjects
|
2.38 Percentage of Subjects
|
5.95 Percentage of Subjects
|
9.09 Percentage of Subjects
|
9.09 Percentage of Subjects
|
2.27 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
A.naeslundii
|
7.14 Percentage of Subjects
|
1.19 Percentage of Subjects
|
17.86 Percentage of Subjects
|
6.82 Percentage of Subjects
|
6.82 Percentage of Subjects
|
13.64 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
S.constellatus
|
65.48 Percentage of Subjects
|
67.86 Percentage of Subjects
|
73.81 Percentage of Subjects
|
79.55 Percentage of Subjects
|
70.45 Percentage of Subjects
|
81.82 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
E.nodatum
|
3.57 Percentage of Subjects
|
3.57 Percentage of Subjects
|
13.10 Percentage of Subjects
|
11.36 Percentage of Subjects
|
6.82 Percentage of Subjects
|
13.64 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
P.gingivalis
|
29.76 Percentage of Subjects
|
21.43 Percentage of Subjects
|
7.14 Percentage of Subjects
|
29.55 Percentage of Subjects
|
15.91 Percentage of Subjects
|
2.27 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
A.actinomucetemcomitans
|
7.14 Percentage of Subjects
|
16.67 Percentage of Subjects
|
19.05 Percentage of Subjects
|
22.73 Percentage of Subjects
|
25.00 Percentage of Subjects
|
11.36 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
F.nucleatum vincentii
|
7.14 Percentage of Subjects
|
11.90 Percentage of Subjects
|
9.52 Percentage of Subjects
|
9.09 Percentage of Subjects
|
9.09 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
C.rectus
|
9.52 Percentage of Subjects
|
13.10 Percentage of Subjects
|
11.90 Percentage of Subjects
|
22.73 Percentage of Subjects
|
13.64 Percentage of Subjects
|
11.36 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
E.saburreum
|
16.67 Percentage of Subjects
|
16.67 Percentage of Subjects
|
65.48 Percentage of Subjects
|
25.00 Percentage of Subjects
|
18.18 Percentage of Subjects
|
65.91 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
P.micra
|
8.33 Percentage of Subjects
|
15.48 Percentage of Subjects
|
23.81 Percentage of Subjects
|
29.55 Percentage of Subjects
|
22.73 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
V.parvula
|
41.67 Percentage of Subjects
|
71.43 Percentage of Subjects
|
53.57 Percentage of Subjects
|
47.73 Percentage of Subjects
|
54.55 Percentage of Subjects
|
31.82 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
A.oris
|
19.05 Percentage of Subjects
|
13.10 Percentage of Subjects
|
7.14 Percentage of Subjects
|
25.00 Percentage of Subjects
|
20.45 Percentage of Subjects
|
2.27 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
S.anginosus
|
30.95 Percentage of Subjects
|
30.95 Percentage of Subjects
|
34.52 Percentage of Subjects
|
50.00 Percentage of Subjects
|
59.09 Percentage of Subjects
|
50.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
S.anguinis
|
76.19 Percentage of Subjects
|
85.71 Percentage of Subjects
|
88.10 Percentage of Subjects
|
75.00 Percentage of Subjects
|
77.27 Percentage of Subjects
|
90.91 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
A.gerencseriae
|
3.57 Percentage of Subjects
|
10.71 Percentage of Subjects
|
2.38 Percentage of Subjects
|
6.82 Percentage of Subjects
|
6.82 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
S.oralis
|
70.24 Percentage of Subjects
|
78.57 Percentage of Subjects
|
82.14 Percentage of Subjects
|
77.27 Percentage of Subjects
|
79.55 Percentage of Subjects
|
88.64 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
C.ochraccea
|
1.19 Percentage of Subjects
|
0.00 Percentage of Subjects
|
1.19 Percentage of Subjects
|
2.27 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
A.israelli
|
0.00 Percentage of Subjects
|
2.38 Percentage of Subjects
|
2.38 Percentage of Subjects
|
2.27 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
S.intermedius
|
48.81 Percentage of Subjects
|
65.48 Percentage of Subjects
|
76.19 Percentage of Subjects
|
63.64 Percentage of Subjects
|
63.64 Percentage of Subjects
|
81.82 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
C.matruchotti
|
2.38 Percentage of Subjects
|
3.57 Percentage of Subjects
|
8.33 Percentage of Subjects
|
4.55 Percentage of Subjects
|
6.82 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
P.nigrescens
|
5.95 Percentage of Subjects
|
8.33 Percentage of Subjects
|
3.57 Percentage of Subjects
|
11.36 Percentage of Subjects
|
2.27 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
A.odontolyticus
|
4.76 Percentage of Subjects
|
19.05 Percentage of Subjects
|
21.43 Percentage of Subjects
|
25.00 Percentage of Subjects
|
20.45 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
F.nucleatum polymorphum
|
11.90 Percentage of Subjects
|
25.00 Percentage of Subjects
|
16.67 Percentage of Subjects
|
13.64 Percentage of Subjects
|
15.91 Percentage of Subjects
|
13.64 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
C.showae
|
4.76 Percentage of Subjects
|
10.71 Percentage of Subjects
|
7.14 Percentage of Subjects
|
34.09 Percentage of Subjects
|
15.91 Percentage of Subjects
|
15.91 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
F.periodonticum
|
1.19 Percentage of Subjects
|
9.52 Percentage of Subjects
|
2.38 Percentage of Subjects
|
2.27 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
N.mucosa
|
35.71 Percentage of Subjects
|
27.38 Percentage of Subjects
|
58.33 Percentage of Subjects
|
36.36 Percentage of Subjects
|
36.36 Percentage of Subjects
|
61.36 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
F.nucleatum
|
1.19 Percentage of Subjects
|
3.57 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
C.ginigivaluis
|
15.48 Percentage of Subjects
|
17.86 Percentage of Subjects
|
7.14 Percentage of Subjects
|
20.45 Percentage of Subjects
|
15.91 Percentage of Subjects
|
2.27 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
S.gordonii
|
72.62 Percentage of Subjects
|
91.67 Percentage of Subjects
|
69.05 Percentage of Subjects
|
81.82 Percentage of Subjects
|
75.00 Percentage of Subjects
|
77.27 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
T.forsythia
|
1.19 Percentage of Subjects
|
2.38 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
2.27 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
S.noxia
|
51.19 Percentage of Subjects
|
65.48 Percentage of Subjects
|
55.95 Percentage of Subjects
|
65.91 Percentage of Subjects
|
54.55 Percentage of Subjects
|
50.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
P.acnes
|
1.19 Percentage of Subjects
|
8.33 Percentage of Subjects
|
10.71 Percentage of Subjects
|
9.09 Percentage of Subjects
|
11.36 Percentage of Subjects
|
11.36 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
P.melaninogenica
|
7.14 Percentage of Subjects
|
3.57 Percentage of Subjects
|
2.38 Percentage of Subjects
|
2.27 Percentage of Subjects
|
2.27 Percentage of Subjects
|
13.64 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
S.mitis
|
75.00 Percentage of Subjects
|
79.76 Percentage of Subjects
|
75.00 Percentage of Subjects
|
81.82 Percentage of Subjects
|
77.27 Percentage of Subjects
|
90.91 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
E.corrodens
|
53.57 Percentage of Subjects
|
57.14 Percentage of Subjects
|
42.86 Percentage of Subjects
|
65.91 Percentage of Subjects
|
52.27 Percentage of Subjects
|
25.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
G.morbillorum
|
22.62 Percentage of Subjects
|
22.62 Percentage of Subjects
|
78.57 Percentage of Subjects
|
36.36 Percentage of Subjects
|
22.73 Percentage of Subjects
|
88.64 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
C.sputigena
|
1.19 Percentage of Subjects
|
0.00 Percentage of Subjects
|
3.57 Percentage of Subjects
|
4.55 Percentage of Subjects
|
0.00 Percentage of Subjects
|
4.55 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
L.bucallis
|
34.52 Percentage of Subjects
|
21.43 Percentage of Subjects
|
28.57 Percentage of Subjects
|
29.55 Percentage of Subjects
|
20.45 Percentage of Subjects
|
15.91 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
C.gracilis
|
7.14 Percentage of Subjects
|
4.76 Percentage of Subjects
|
4.76 Percentage of Subjects
|
4.55 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Plaque Samples
P.intermedia
|
29.76 Percentage of Subjects
|
19.05 Percentage of Subjects
|
36.90 Percentage of Subjects
|
27.27 Percentage of Subjects
|
18.18 Percentage of Subjects
|
31.82 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline, Day 30 and Day 180Population: ITT
Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects
Outcome measures
| Measure |
Minocycline HCl Microspheres
n=23 Participants
A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
|
No Drug Intervention
n=23 Participants
A control consisting of no drug intervention
|
Micocycline Group at 180 Days
n=23 Participants
|
Control Group at Baseline
n=12 Participants
|
Control Group at 30 Days
n=12 Participants
|
Control Group at 180 Days
n=12 Participants
|
|---|---|---|---|---|---|---|
|
Micocycline-Resistance From Saliva Sample
G.morbillorum
|
38.10 Percentage of Subjects
|
14.29 Percentage of Subjects
|
76.19 Percentage of Subjects
|
27.27 Percentage of Subjects
|
0.00 Percentage of Subjects
|
100.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
A.naeslundii
|
4.76 Percentage of Subjects
|
0.00 Percentage of Subjects
|
19.05 Percentage of Subjects
|
9.09 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
S.constellatus
|
47.62 Percentage of Subjects
|
42.86 Percentage of Subjects
|
80.95 Percentage of Subjects
|
72.73 Percentage of Subjects
|
63.64 Percentage of Subjects
|
63.64 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
E.nodatum
|
4.76 Percentage of Subjects
|
0.00 Percentage of Subjects
|
14.29 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
P.gingivalis
|
23.81 Percentage of Subjects
|
19.05 Percentage of Subjects
|
9.52 Percentage of Subjects
|
27.27 Percentage of Subjects
|
18.18 Percentage of Subjects
|
18.18 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
A.actinomucetemcomitans
|
19.05 Percentage of Subjects
|
9.52 Percentage of Subjects
|
14.29 Percentage of Subjects
|
27.27 Percentage of Subjects
|
0.00 Percentage of Subjects
|
27.27 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
F.nucleatum vincentii
|
9.52 Percentage of Subjects
|
0.00 Percentage of Subjects
|
19.05 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
18.18 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
C.rectus
|
9.52 Percentage of Subjects
|
9.52 Percentage of Subjects
|
14.29 Percentage of Subjects
|
18.18 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
R.dentocariosa
|
4.76 Percentage of Subjects
|
0.00 Percentage of Subjects
|
14.29 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
E.saburreum
|
19.05 Percentage of Subjects
|
14.29 Percentage of Subjects
|
61.90 Percentage of Subjects
|
27.27 Percentage of Subjects
|
0.00 Percentage of Subjects
|
72.73 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
P.micra
|
14.29 Percentage of Subjects
|
9.52 Percentage of Subjects
|
23.81 Percentage of Subjects
|
18.18 Percentage of Subjects
|
0.00 Percentage of Subjects
|
18.18 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
V.parvula
|
61.90 Percentage of Subjects
|
90.48 Percentage of Subjects
|
80.95 Percentage of Subjects
|
81.82 Percentage of Subjects
|
81.82 Percentage of Subjects
|
90.91 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
A.oris
|
14.29 Percentage of Subjects
|
14.29 Percentage of Subjects
|
14.29 Percentage of Subjects
|
27.27 Percentage of Subjects
|
18.18 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
S.anginosus
|
14.29 Percentage of Subjects
|
14.29 Percentage of Subjects
|
42.86 Percentage of Subjects
|
27.27 Percentage of Subjects
|
9.09 Percentage of Subjects
|
45.45 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
S.anguinis
|
61.90 Percentage of Subjects
|
85.71 Percentage of Subjects
|
100.00 Percentage of Subjects
|
72.73 Percentage of Subjects
|
72.73 Percentage of Subjects
|
100.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
A.gerencseriae
|
4.76 Percentage of Subjects
|
14.29 Percentage of Subjects
|
9.52 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
S.oralis
|
66.67 Percentage of Subjects
|
71.43 Percentage of Subjects
|
100.00 Percentage of Subjects
|
63.64 Percentage of Subjects
|
90.91 Percentage of Subjects
|
90.91 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
C.ochraccea
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
4.76 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
A.israelli
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
S.intermedius
|
42.86 Percentage of Subjects
|
38.10 Percentage of Subjects
|
80.95 Percentage of Subjects
|
63.64 Percentage of Subjects
|
45.45 Percentage of Subjects
|
90.91 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
C.matruchotti
|
9.52 Percentage of Subjects
|
9.52 Percentage of Subjects
|
23.81 Percentage of Subjects
|
9.09 Percentage of Subjects
|
9.09 Percentage of Subjects
|
36.36 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
P.nigrescens
|
9.52 Percentage of Subjects
|
4.76 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
A.odontolyticus
|
23.81 Percentage of Subjects
|
19.05 Percentage of Subjects
|
28.57 Percentage of Subjects
|
45.45 Percentage of Subjects
|
0.00 Percentage of Subjects
|
36.36 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
F.nucleatum polymorphum
|
19.05 Percentage of Subjects
|
19.05 Percentage of Subjects
|
14.29 Percentage of Subjects
|
9.09 Percentage of Subjects
|
9.09 Percentage of Subjects
|
27.27 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
C.showae
|
19.05 Percentage of Subjects
|
9.52 Percentage of Subjects
|
4.76 Percentage of Subjects
|
36.36 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
F.periodonticum
|
4.76 Percentage of Subjects
|
4.76 Percentage of Subjects
|
4.76 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
N.mucosa
|
47.62 Percentage of Subjects
|
28.57 Percentage of Subjects
|
76.19 Percentage of Subjects
|
36.36 Percentage of Subjects
|
27.27 Percentage of Subjects
|
72.73 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
F.nucleatum
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.52 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
C.ginigivaluis
|
23.81 Percentage of Subjects
|
9.52 Percentage of Subjects
|
19.05 Percentage of Subjects
|
18.18 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.09 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
S.gordonii
|
71.43 Percentage of Subjects
|
85.71 Percentage of Subjects
|
66.67 Percentage of Subjects
|
72.73 Percentage of Subjects
|
45.45 Percentage of Subjects
|
72.73 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
T.forsythia
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
S.noxia
|
52.38 Percentage of Subjects
|
52.38 Percentage of Subjects
|
57.14 Percentage of Subjects
|
54.55 Percentage of Subjects
|
54.55 Percentage of Subjects
|
72.73 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
P.acnes
|
9.52 Percentage of Subjects
|
9.52 Percentage of Subjects
|
19.05 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
27.27 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
P.melaninogenica
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
19.05 Percentage of Subjects
|
18.18 Percentage of Subjects
|
18.18 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
S.mitis
|
61.90 Percentage of Subjects
|
71.43 Percentage of Subjects
|
90.48 Percentage of Subjects
|
81.82 Percentage of Subjects
|
90.91 Percentage of Subjects
|
100.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
E.corrodens
|
57.14 Percentage of Subjects
|
47.62 Percentage of Subjects
|
57.14 Percentage of Subjects
|
72.73 Percentage of Subjects
|
81.82 Percentage of Subjects
|
45.45 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
C.sputigena
|
9.52 Percentage of Subjects
|
4.76 Percentage of Subjects
|
0.00 Percentage of Subjects
|
9.09 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
L.bucallis
|
33.33 Percentage of Subjects
|
23.81 Percentage of Subjects
|
38.10 Percentage of Subjects
|
18.18 Percentage of Subjects
|
9.09 Percentage of Subjects
|
27.27 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
C.gracilis
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
4.76 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
0.00 Percentage of Subjects
|
|
Micocycline-Resistance From Saliva Sample
P.intermedia
|
23.81 Percentage of Subjects
|
19.05 Percentage of Subjects
|
33.33 Percentage of Subjects
|
18.18 Percentage of Subjects
|
27.27 Percentage of Subjects
|
54.55 Percentage of Subjects
|
Adverse Events
Minocycline HCl Microspheres
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
No Drug Intervention
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Minocycline HCl Microspheres
n=23 participants at risk
A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
|
No Drug Intervention
n=12 participants at risk
A control consisting of no drug intervention
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
4.3%
1/23 • Number of events 1 • 180 Days
|
0.00%
0/12 • 180 Days
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/23 • 180 Days
|
8.3%
1/12 • Number of events 1 • 180 Days
|
Other adverse events
| Measure |
Minocycline HCl Microspheres
n=23 participants at risk
A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
|
No Drug Intervention
n=12 participants at risk
A control consisting of no drug intervention
|
|---|---|---|
|
Infections and infestations
SINUSITIS
|
8.7%
2/23 • Number of events 2 • 180 Days
|
0.00%
0/12 • 180 Days
|
|
Infections and infestations
ABSCESS ORAL
|
0.00%
0/23 • 180 Days
|
8.3%
1/12 • Number of events 1 • 180 Days
|
|
Gastrointestinal disorders
ORAL DISCOMFORT
|
0.00%
0/23 • 180 Days
|
8.3%
1/12 • Number of events 1 • 180 Days
|
|
Gastrointestinal disorders
TOOTHACHE
|
8.7%
2/23 • Number of events 2 • 180 Days
|
0.00%
0/12 • 180 Days
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
8.7%
2/23 • Number of events 2 • 180 Days
|
0.00%
0/12 • 180 Days
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/23 • 180 Days
|
8.3%
1/12 • Number of events 1 • 180 Days
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.7%
2/23 • Number of events 2 • 180 Days
|
0.00%
0/12 • 180 Days
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.00%
0/23 • 180 Days
|
8.3%
1/12 • Number of events 1 • 180 Days
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/23 • 180 Days
|
8.3%
1/12 • Number of events 1 • 180 Days
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/23 • 180 Days
|
8.3%
1/12 • Number of events 1 • 180 Days
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/23 • 180 Days
|
8.3%
1/12 • Number of events 1 • 180 Days
|
Additional Information
Ms. Bindu Patel, Senior Scientist, Regulatory Affairs and Quality Assurance
OraPharma
Phone: 215-420-4064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place