Trial Outcomes & Findings for A Study to Determine the Effects of Adding an Experimental Device With Mouthrinse to Oral Care Regimen (NCT NCT01419626)
NCT ID: NCT01419626
Last Updated: 2019-12-17
Results Overview
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 millimeter \[mm\]), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
COMPLETED
NA
140 participants
Week 4
2019-12-17
Participant Flow
Participant milestones
| Measure |
Negative Control Group (Toothbrushing Only)
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device+ Oil-containing Mouthrinse)
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
47
|
|
Overall Study
COMPLETED
|
42
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
Reasons for withdrawal
| Measure |
Negative Control Group (Toothbrushing Only)
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device+ Oil-containing Mouthrinse)
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
A Study to Determine the Effects of Adding an Experimental Device With Mouthrinse to Oral Care Regimen
Baseline characteristics by cohort
| Measure |
Negative Control Group (Toothbrushing Only)
n=46 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=47 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device+ Oil-containing Mouthrinse)
n=47 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 11.27 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 11.31 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Full analysis set (FAS) included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 millimeter \[mm\]), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Outcome measures
| Measure |
Negative Control Group (Toothbrushing Only)
n=42 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Interproximal Mean Plaque Index at Week 4
|
2.674 Units on a scale
Standard Error 0.0432
|
2.213 Units on a scale
Standard Error 0.0422
|
2.005 Units on a scale
Standard Error 0.0422
|
PRIMARY outcome
Timeframe: Week 4Population: FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Outcome measures
| Measure |
Negative Control Group (Toothbrushing Only)
n=42 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Whole-mouth Mean Plaque Index at Week 4
|
2.545 Units on a scale
Standard Error 0.0473
|
2.051 Units on a scale
Standard Error 0.0462
|
1.848 Units on a scale
Standard Error 0.0462
|
SECONDARY outcome
Timeframe: Week 2 and 4Population: FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.
Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Outcome measures
| Measure |
Negative Control Group (Toothbrushing Only)
n=42 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Interproximal Mean Modified Gingival Index (Mean MGI) at Week 2 and 4
Week 2
|
2.067 Units on a scale
Standard Error 0.0069
|
2.027 Units on a scale
Standard Error 0.0067
|
2.023 Units on a scale
Standard Error 0.0068
|
|
Interproximal Mean Modified Gingival Index (Mean MGI) at Week 2 and 4
Week 4
|
2.071 Units on a scale
Standard Error 0.0108
|
1.980 Units on a scale
Standard Error 0.0106
|
1.927 Units on a scale
Standard Error 0.0107
|
SECONDARY outcome
Timeframe: Week 2 and 4Population: FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.
Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Outcome measures
| Measure |
Negative Control Group (Toothbrushing Only)
n=42 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Whole-mouth Modified Gingival Index (Mean MGI) at Week 2 and 4
Week 2
|
2.142 Units on a scale
Standard Error 0.0091
|
2.052 Units on a scale
Standard Error 0.0089
|
1.979 Units on a scale
Standard Error 0.0090
|
|
Whole-mouth Modified Gingival Index (Mean MGI) at Week 2 and 4
Week 4
|
2.144 Units on a scale
Standard Error 0.0109
|
1.995 Units on a scale
Standard Error 0.0106
|
1.888 Units on a scale
Standard Error 0.0107
|
SECONDARY outcome
Timeframe: Week 2Population: FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Outcome measures
| Measure |
Negative Control Group (Toothbrushing Only)
n=42 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Interproximal Mean Plaque Index (Mean PI) at Week 2
|
2.794 Units on a scale
Standard Error 0.0372
|
2.431 Units on a scale
Standard Error 0.0364
|
2.260 Units on a scale
Standard Error 0.0364
|
SECONDARY outcome
Timeframe: Week 2Population: FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Outcome measures
| Measure |
Negative Control Group (Toothbrushing Only)
n=42 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Whole-mouth Mean Plaque Index (Mean PI) at Week 2
|
2.688 Units on a scale
Standard Error 0.0395
|
2.287 Units on a scale
Standard Error 0.0386
|
2.130 Units on a scale
Standard Error 0.0386
|
SECONDARY outcome
Timeframe: Week 2 and 4Population: FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.
Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding.
Outcome measures
| Measure |
Negative Control Group (Toothbrushing Only)
n=42 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Interproximal Mean Bleeding Index (Mean BI) at Week 2 and 4
Week 2
|
0.059 Units on a scale
Standard Error 0.0058
|
0.028 Units on a scale
Standard Error 0.0057
|
0.020 Units on a scale
Standard Error 0.0057
|
|
Interproximal Mean Bleeding Index (Mean BI) at Week 2 and 4
Week 4
|
0.052 Units on a scale
Standard Error 0.0059
|
0.033 Units on a scale
Standard Error 0.0057
|
0.018 Units on a scale
Standard Error 0.0058
|
SECONDARY outcome
Timeframe: Week 2 and 4Population: FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.
Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding.
Outcome measures
| Measure |
Negative Control Group (Toothbrushing Only)
n=42 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) twice daily with provided toothpaste as their sole means of oral hygiene for up to 4 Weeks.
|
Device Control Group (Toothbrushing, Device + Water)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) and provided toothpaste twice daily with an experimental interdental cleaning device to use with water once a day after brushing for up to 4 Weeks.
|
Test Group (Toothbrushing, Device + Oil-containing Mouthrinse)
n=44 Participants
Following randomization, participants started brushing teeth with a manual toothbrush (Advanced Design Toothbrush - ADR # PR-000172) provided toothpaste twice daily with an experimental interdental cleaning device to use with the assigned marketed antiseptic mouthrinse (essential oil-containing mouthrinse) once a day after brushing for up to 4 Weeks.
|
|---|---|---|---|
|
Whole-mouth Mean Bleeding Index (Mean BI) at Week 2 and 4
Week 2
|
0.160 Units on a scale
Standard Error 0.0059
|
0.094 Units on a scale
Standard Error 0.0058
|
0.078 Units on a scale
Standard Error 0.0058
|
|
Whole-mouth Mean Bleeding Index (Mean BI) at Week 2 and 4
Week 4
|
0.154 Units on a scale
Standard Error 0.0065
|
0.077 Units on a scale
Standard Error 0.0064
|
0.052 Units on a scale
Standard Error 0.0064
|
Adverse Events
Negative Control Group (Toothbrushing Only)
Device Control Group (Toothbrushing, Device + Water)
Test Group (Toothbrushing, Device+ Oil-containing Mouthrinse)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
DIRECTOR ORAL HEALTH, MEDICAL AFFAIR & CLINICAL RESEARCH
Johnson & Johnson Consumer and Personal Products Worldwide
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER