Trial Outcomes & Findings for Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health (NCT NCT02187016)
NCT ID: NCT02187016
Last Updated: 2016-03-08
Results Overview
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
290 participants
Primary outcome timeframe
14 days
Results posted on
2016-03-08
Participant Flow
Participant milestones
| Measure |
AirFloss + Rinse1
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
Manual Toothbrush is used twice a day for 1 minute
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
79
|
51
|
|
Overall Study
COMPLETED
|
79
|
78
|
78
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health
Baseline characteristics by cohort
| Measure |
AirFloss + Rinse1
n=79 Participants
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
n=78 Participants
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
n=79 Participants
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
n=51 Participants
Manual Toothbrush is used twice a day for 1 minute
|
Total
n=287 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 12.20 • n=99 Participants
|
35.6 years
STANDARD_DEVIATION 10.70 • n=107 Participants
|
34.9 years
STANDARD_DEVIATION 11.00 • n=206 Participants
|
35.1 years
STANDARD_DEVIATION 12.10 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 11.50 • n=31 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
184 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
103 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=99 Participants
|
78 participants
n=107 Participants
|
79 participants
n=206 Participants
|
51 participants
n=7 Participants
|
287 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 14 daysMGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Outcome measures
| Measure |
AirFloss + Rinse1
n=79 Participants
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
n=78 Participants
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
n=79 Participants
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
n=51 Participants
Manual Toothbrush is used twice a day for 1 minute
|
|---|---|---|---|---|
|
Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
|
0.10 units on a scale
Standard Error 0.01
|
0.10 units on a scale
Standard Error 0.01
|
0.10 units on a scale
Standard Error 0.01
|
0.01 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: 28 daysMGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).
Outcome measures
| Measure |
AirFloss + Rinse1
n=79 Participants
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
n=78 Participants
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
n=78 Participants
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
n=51 Participants
Manual Toothbrush is used twice a day for 1 minute
|
|---|---|---|---|---|
|
Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
|
0.20 units on a scale
Standard Error 0.01
|
0.22 units on a scale
Standard Error 0.01
|
0.26 units on a scale
Standard Error 0.01
|
0.03 units on a scale
Standard Error 0.02
|
SECONDARY outcome
Timeframe: 14 daysGBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Outcome measures
| Measure |
AirFloss + Rinse1
n=79 Participants
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
n=78 Participants
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
n=79 Participants
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
n=51 Participants
Manual Toothbrush is used twice a day for 1 minute
|
|---|---|---|---|---|
|
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
|
0.05 units on a scale
Standard Error 0.00
|
0.05 units on a scale
Standard Error 0.00
|
0.05 units on a scale
Standard Error 0.00
|
0.00 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: 28 daysGBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Outcome measures
| Measure |
AirFloss + Rinse1
n=79 Participants
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
n=78 Participants
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
n=78 Participants
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
n=51 Participants
Manual Toothbrush is used twice a day for 1 minute
|
|---|---|---|---|---|
|
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
|
0.08 units on a scale
Standard Error 0.00
|
0.08 units on a scale
Standard Error 0.00
|
0.09 units on a scale
Standard Error 0.00
|
0.01 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: 14 daysRMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Outcome measures
| Measure |
AirFloss + Rinse1
n=79 Participants
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
n=78 Participants
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
n=79 Participants
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
n=51 Participants
Manual Toothbrush is used twice a day for 1 minute
|
|---|---|---|---|---|
|
Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
|
0.09 units on a scale
Standard Error 0.01
|
0.10 units on a scale
Standard Error 0.01
|
0.11 units on a scale
Standard Error 0.01
|
0.04 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: 28 daysRMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Outcome measures
| Measure |
AirFloss + Rinse1
n=79 Participants
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
n=78 Participants
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
n=78 Participants
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
n=51 Participants
Manual Toothbrush is used twice a day for 1 minute
|
|---|---|---|---|---|
|
Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
|
0.15 units on a scale
Standard Error 0.01
|
0.16 units on a scale
Standard Error 0.01
|
0.17 units on a scale
Standard Error 0.01
|
0.04 units on a scale
Standard Error 0.01
|
Adverse Events
AirFloss + Rinse1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AirFloss + Rinse2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
String Floss
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Manual Toothbrush
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AirFloss + Rinse1
n=79 participants at risk
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
AirFloss + Rinse2
n=78 participants at risk
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
|
String Floss
n=78 participants at risk
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
|
Manual Toothbrush
n=51 participants at risk
Manual Toothbrush is used twice a day for 1 minute
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Gingival Irritation
|
2.5%
2/79 • Oral changes from baseline evaluated at Day 14 and 28
|
1.3%
1/78 • Oral changes from baseline evaluated at Day 14 and 28
|
1.3%
1/78 • Oral changes from baseline evaluated at Day 14 and 28
|
0.00%
0/51 • Oral changes from baseline evaluated at Day 14 and 28
|
Additional Information
Pejjmon Amini, DMD
Silverstone Research Group
Phone: 702-901-444
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place