Trial Outcomes & Findings for A Study to Evaluate the Microbiology, Safety and Tolerability of C16G2 Dental Strip Application (NCT NCT03052842)
NCT ID: NCT03052842
Last Updated: 2022-12-22
Results Overview
To assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. The antimicrobial activity of crystal violet dye, high sucrose content, sodium tellurite and bacitracin effectively prevent the growth of all bacteria except for streptococci. Further differentiation of streptococci is accomplished by observing colony morphology. S. mutans grows in large blue colonies with dry frosted tops or pale blue gumdrops and can be differentiated from other bacterial colonies.
COMPLETED
PHASE2
30 participants
Measured up to 1 months post last study drug administration
2022-12-22
Participant Flow
Participant milestones
| Measure |
Arm 1A: 9.2 mg C16G2
Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 2A: 18.4 mg C16G2
Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 3A: 36.8 mg C16G2
Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects).
|
Group: Pooled Placebo
Subjects enrolled in Arms 1B (N=2), 2B (N=2) and 3B (N=2) were pooled into one group.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N=8: Participants who received 9.2mg C16G2, 18.4mg C16G2, and 36.8mg C16G2, respectively N=6: placebo particpants from 3 arms
Baseline characteristics by cohort
| Measure |
Arm 1A: 9.2 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 2A: 18.4 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
Placebo Strip: Placebo
|
Arm 3A: 36.8 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects).
|
Group: Pooled Placebo
n=6 Participants
Subjects enrolled in Arms 1B (N=2), 2B (N=2) and 3B (N=2) were pooled into one group.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
26.2 years
n=5 Participants • N=8: Participants who received 9.2mg C16G2, 18.4mg C16G2, and 36.8mg C16G2, respectively N=6: placebo particpants from 3 arms
|
26.2 years
n=7 Participants • N=8: Participants who received 9.2mg C16G2, 18.4mg C16G2, and 36.8mg C16G2, respectively N=6: placebo particpants from 3 arms
|
31.1 years
n=5 Participants • N=8: Participants who received 9.2mg C16G2, 18.4mg C16G2, and 36.8mg C16G2, respectively N=6: placebo particpants from 3 arms
|
23 years
n=4 Participants • N=8: Participants who received 9.2mg C16G2, 18.4mg C16G2, and 36.8mg C16G2, respectively N=6: placebo particpants from 3 arms
|
26.9 years
n=21 Participants • N=8: Participants who received 9.2mg C16G2, 18.4mg C16G2, and 36.8mg C16G2, respectively N=6: placebo particpants from 3 arms
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
30 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured up to 1 months post last study drug administrationTo assess the targeted antimicrobial activity of C16G2 applications as measured by a reduction in Streptococcus mutans in saliva and dental plaque using S. mutans CFUs using mitis-salivarius bacitrain (MSB) agar plating. Streptococcus species present in the oral cavity have been traditionally isolated from oral cavity samples using MSB agar plates. The antimicrobial activity of crystal violet dye, high sucrose content, sodium tellurite and bacitracin effectively prevent the growth of all bacteria except for streptococci. Further differentiation of streptococci is accomplished by observing colony morphology. S. mutans grows in large blue colonies with dry frosted tops or pale blue gumdrops and can be differentiated from other bacterial colonies.
Outcome measures
| Measure |
Arm 1A: 9.2 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 2A: 18.4 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 3A: 36.8 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects).
|
Group: Pooled Placebo
n=6 Participants
Subjects enrolled in Arms 1B (N=2), 2B (N=2) and 3B (N=2) were pooled into one group.
|
|---|---|---|---|---|
|
Antimicrobial Activity of C16G2
Saliva Sample: S. mutans Change from Baseline to Visit 22
|
-0.2 CFU/mL
Standard Deviation 1.16
|
-0.04 CFU/mL
Standard Deviation 0.79
|
0.005 CFU/mL
Standard Deviation 0.34
|
0.15 CFU/mL
Standard Deviation 0.41
|
|
Antimicrobial Activity of C16G2
Dental Plaque Sample: S. mutans Change from Baseline to Visit 22
|
0.14 CFU/mL
Standard Deviation 0.93
|
-0.19 CFU/mL
Standard Deviation 1.09
|
0.36 CFU/mL
Standard Deviation 0.29
|
0.24 CFU/mL
Standard Deviation 1.02
|
PRIMARY outcome
Timeframe: Measured up to 1 months post last study drug administrationTo assess total bacteria in saliva and dental plaque post study drug administration using total bacteria CFUs using Todd Hewitt (TH) agar plating and the log transformed changes from baseline Total Bacteria levels in dental plaque and saliva including N, mean, SD, median and range at each assessment time point following the first administration of C16G2.
Outcome measures
| Measure |
Arm 1A: 9.2 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 2A: 18.4 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 3A: 36.8 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects).
|
Group: Pooled Placebo
n=6 Participants
Subjects enrolled in Arms 1B (N=2), 2B (N=2) and 3B (N=2) were pooled into one group.
|
|---|---|---|---|---|
|
Total Oral Bacterial Levels
Saliva Sample - Total Bacteria by TH Agar Plating from Baseline to Visit 22
|
0.28 CFU/mL
Standard Deviation 0.38
|
0.33 CFU/mL
Standard Deviation 0.40
|
0.26 CFU/mL
Standard Deviation 0.22
|
0.30 CFU/mL
Standard Deviation 0.64
|
|
Total Oral Bacterial Levels
Dental Plaque Sample - Total Bacteria by TH Agar Plating from Baseline to Visit 22
|
0.46 CFU/mL
Standard Deviation 0.49
|
0.10 CFU/mL
Standard Deviation 0.89
|
0.53 CFU/mL
Standard Deviation 0.42
|
0.08 CFU/mL
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Up to 1 week post last study drug administrationSafety will be assessed by performing targeted physical examinations, oral cavity exams, taking vital signs and collection of adverse events categorized according to system organ class (SOC) and preferred term (PT) based on coding to the Medical Dictionary for Regulatory Activities (MedDRA®), Version 17.1. Comprehensive examinations of oral hard and soft tissue structures, as well as targeted exams of specific musculoskeletal and extraoral sites were performed at selected time points; vital signs (blood pressure, heart rate and temperature) were taken.
Outcome measures
| Measure |
Arm 1A: 9.2 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 9.2 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 2A: 18.4 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 18.4 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects). Study arm will be fully enrolled (i.e., the last subject in an arm has completed Visit 3) before enrollment is initiated in the next study arm.
|
Arm 3A: 36.8 mg C16G2
n=8 Participants
Study subjects will be randomized to receive 36.8 mg C16G2 Strip or Placebo in a 4:1 allocation ratio (8 C16G2 Strip subjects: 2 Placebo Strip subjects).
|
Group: Pooled Placebo
n=6 Participants
Subjects enrolled in Arms 1B (N=2), 2B (N=2) and 3B (N=2) were pooled into one group.
|
|---|---|---|---|---|
|
To Evaluate the Safety and Tolerability of Multiple C16G2
Participants with Adverse Events Related to Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety and Tolerability of Multiple C16G2
Participants with Clinical Significant Oral Cavity Changes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety and Tolerability of Multiple C16G2
Participants with Clinical Significant Vital Sign Changes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety and Tolerability of Multiple C16G2
Participants with Abnormal Physical Exam Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety and Tolerability of Multiple C16G2
Participants with Completed Study
|
8 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
Adverse Events
Arm 1A: 9.2 mg C16G2
Arm 2A: 18.4 mg C16G2
Arm 3A: 36.8 mg C16G2
Group: Pooled Placebo
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