Trial Outcomes & Findings for Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis (NCT NCT00529555)
NCT ID: NCT00529555
Last Updated: 2014-05-09
Results Overview
Average change of Pocket Depth at 9 months from baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
602 participants
Primary outcome timeframe
baseline & 9 months
Results posted on
2014-05-09
Participant Flow
Participant milestones
| Measure |
Scaling and Root Planing + SHAM TX
Empty syringe + Scaling and root planing
|
Scaling & Root Planing + Periocline Gel
Gel WITH Minocycline HCL 2.1% + Scaling \& root planing
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
|
Scaling and Root Planing + Vehicle
Gel WITHOUT 2.1% Minocycline HCl + Scaling and root planing
|
|---|---|---|---|
|
Overall Study
STARTED
|
200
|
202
|
200
|
|
Overall Study
COMPLETED
|
171
|
172
|
174
|
|
Overall Study
NOT COMPLETED
|
29
|
30
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis
Baseline characteristics by cohort
| Measure |
Scaling and Root Planing + SHAM TX
n=200 Participants
sham treatment
Scaling and root planing : scaling and root planing
|
Scaling & Root Planing + Periocline Gel
n=202 Participants
Minocycline HCL 2.1%
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
|
Scaling and Root Planing + Vehicle
n=200 Participants
Placebo
Scaling and root planing : scaling and root planing
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
193 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
587 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
302 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=5 Participants
|
202 participants
n=7 Participants
|
200 participants
n=5 Participants
|
602 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline & 9 monthsPopulation: Intent to treat
Average change of Pocket Depth at 9 months from baseline
Outcome measures
| Measure |
Scaling and Root Planing + SHAM TX
n=200 Participants
sham treatment
Scaling and root planing : scaling and root planing
|
Scaling and Root Planing + Periocline Gel
n=202 Participants
Minocycline HCL 2.1%
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
|
Scaling and Root Planing + Vehicle
n=200 Participants
Placebo
Scaling and root planing : scaling and root planing
|
|---|---|---|---|
|
Change in Pocket Depth.
|
-1.4 mm
Interval -1.7 to -1.1
|
-1.6 mm
Interval -1.8 to -1.3
|
-1.4 mm
Interval -1.7 to -1.1
|
Adverse Events
Scaling and Root Planing + SHAM TX
Serious events: 8 serious events
Other events: 173 other events
Deaths: 0 deaths
Scaling & Root Planing + Periocline Gel
Serious events: 5 serious events
Other events: 189 other events
Deaths: 0 deaths
Scaling and Root Planing + Vehicle
Serious events: 3 serious events
Other events: 182 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Scaling and Root Planing + SHAM TX
n=200 participants at risk
sham treatment
Scaling and root planing : scaling and root planing
|
Scaling & Root Planing + Periocline Gel
n=202 participants at risk
Minocycline HCL 2.1%
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
|
Scaling and Root Planing + Vehicle
n=200 participants at risk
Placebo
Scaling and root planing : scaling and root planing
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.50%
1/200 • Number of events 1
|
0.00%
0/202
|
0.00%
0/200
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.50%
1/200 • Number of events 1
|
0.00%
0/202
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.50%
1/200 • Number of events 1
|
0.00%
0/202
|
0.00%
0/200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
0.50%
1/200 • Number of events 1
|
0.00%
0/202
|
0.00%
0/200
|
|
Social circumstances
Death
|
0.00%
0/200
|
0.50%
1/202 • Number of events 1
|
0.00%
0/200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/200
|
0.00%
0/202
|
0.50%
1/200 • Number of events 1
|
|
Cardiac disorders
Cellulitis and pulmonary embolism
|
0.50%
1/200 • Number of events 1
|
0.00%
0/202
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Hysterectomy
|
0.00%
0/200
|
0.00%
0/202
|
0.50%
1/200 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction and fatigue
|
0.50%
1/200 • Number of events 1
|
0.00%
0/202
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Right knee replacement surgery
|
0.00%
0/200
|
0.50%
1/202 • Number of events 1
|
0.00%
0/200
|
|
Cardiac disorders
Transient ischemic attack
|
0.00%
0/200
|
0.50%
1/202 • Number of events 1
|
0.00%
0/200
|
|
Social circumstances
Chest pain
|
0.00%
0/200
|
0.50%
1/202 • Number of events 1
|
0.00%
0/200
|
|
Reproductive system and breast disorders
Cellulitis of male organ external epididymitis
|
0.50%
1/200 • Number of events 1
|
0.00%
0/202
|
0.00%
0/200
|
|
Musculoskeletal and connective tissue disorders
Hopsitalization for complications from Multiple Sclerosis
|
0.00%
0/200
|
0.00%
0/202
|
0.50%
1/200 • Number of events 1
|
|
Surgical and medical procedures
Pain and injury
|
0.50%
1/200 • Number of events 1
|
0.00%
0/202
|
0.00%
0/200
|
|
Social circumstances
Cast
|
0.00%
0/200
|
0.50%
1/202 • Number of events 1
|
0.00%
0/200
|
Other adverse events
| Measure |
Scaling and Root Planing + SHAM TX
n=200 participants at risk
sham treatment
Scaling and root planing : scaling and root planing
|
Scaling & Root Planing + Periocline Gel
n=202 participants at risk
Minocycline HCL 2.1%
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
|
Scaling and Root Planing + Vehicle
n=200 participants at risk
Placebo
Scaling and root planing : scaling and root planing
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
69.0%
138/200 • Number of events 412
|
69.3%
140/202 • Number of events 430
|
67.0%
134/200 • Number of events 338
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
35.5%
71/200 • Number of events 129
|
67.8%
137/202 • Number of events 485
|
69.0%
138/200 • Number of events 495
|
|
General disorders
Gerenal Disorders and adminstration site conditions
|
15.0%
30/200 • Number of events 43
|
64.9%
131/202 • Number of events 141
|
54.5%
109/200 • Number of events 116
|
|
Infections and infestations
Infections and infestations
|
22.0%
44/200 • Number of events 63
|
20.3%
41/202 • Number of events 51
|
20.0%
40/200 • Number of events 50
|
|
Nervous system disorders
Nervous system disorders
|
8.0%
16/200 • Number of events 78
|
5.4%
11/202 • Number of events 16
|
8.0%
16/200 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
6.0%
12/200 • Number of events 35
|
7.9%
16/202 • Number of events 23
|
5.5%
11/200 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
13.5%
27/200 • Number of events 41
|
9.4%
19/202 • Number of events 30
|
12.5%
25/200 • Number of events 36
|
Additional Information
Marie Wilson, Clinical Program Manager
Sunstar Americas, Inc
Phone: 773-481-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER