Trial Outcomes & Findings for A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation (NCT NCT02233998)
NCT ID: NCT02233998
Last Updated: 2015-08-21
Results Overview
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.
COMPLETED
NA
158 participants
3 Weeks
2015-08-21
Participant Flow
Participant milestones
| Measure |
Negative Control (W002194-221P)
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
53
|
|
Overall Study
COMPLETED
|
53
|
52
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation
Baseline characteristics by cohort
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 12.48 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 11.66 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
53 participants
n=5 Participants
|
52 participants
n=7 Participants
|
53 participants
n=5 Participants
|
158 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Whole Mouth Mean Modified Gingival Index (MGI) at Week 3
|
2.004 units on a scale
Standard Error 0.0114
|
1.770 units on a scale
Standard Error 0.0115
|
1.807 units on a scale
Standard Error 0.0113
|
PRIMARY outcome
Timeframe: 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Whole Mouth Mean Plaque Index (PI) at Week 3
|
2.434 units on a scale
Standard Error 0.0202
|
1.965 units on a scale
Standard Error 0.0204
|
2.055 units on a scale
Standard Error 0.0202
|
SECONDARY outcome
Timeframe: 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3
|
0.098 units on a scale
Standard Error 0.0042
|
0.067 units on a scale
Standard Error 0.0042
|
0.072 units on a scale
Standard Error 0.0042
|
SECONDARY outcome
Timeframe: Baseline to 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3
|
5.5 percentage of MGI scores of 0 or 1
Standard Deviation 4.52
|
27.5 percentage of MGI scores of 0 or 1
Standard Deviation 9.45
|
24.3 percentage of MGI scores of 0 or 1
Standard Deviation 8.68
|
SECONDARY outcome
Timeframe: Baseline to 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3
|
3.2 percentage of PI scores of 0 or 1
Standard Deviation 3.60
|
20.9 percentage of PI scores of 0 or 1
Standard Deviation 10.76
|
18.3 percentage of PI scores of 0 or 1
Standard Deviation 9.55
|
SECONDARY outcome
Timeframe: Baseline to 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3
|
0.3 percentage of BI scores of 0
Standard Deviation 2.30
|
2.5 percentage of BI scores of 0
Standard Deviation 2.66
|
2.1 percentage of BI scores of 0
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: Baseline to 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3
|
-0.6 percentage of MGI scores of >= 3
Standard Deviation 4.34
|
0.9 percentage of MGI scores of >= 3
Standard Deviation 4.15
|
0.3 percentage of MGI scores of >= 3
Standard Deviation 3.85
|
SECONDARY outcome
Timeframe: Baseline to 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3
|
0.1 percentage of PI scores of >= 3
Standard Deviation 13.12
|
23.5 percentage of PI scores of >= 3
Standard Deviation 14.45
|
18.9 percentage of PI scores of >= 3
Standard Deviation 13.84
|
SECONDARY outcome
Timeframe: Baseline to 3 WeeksPopulation: Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.
Outcome measures
| Measure |
Negative Control (W002194-221P)
n=53 Participants
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
|
19292-116A
n=52 Participants
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
|
11965-059
n=53 Participants
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3
|
3.2 percentage of PI scores of >= 2
Standard Deviation 3.60
|
20.9 percentage of PI scores of >= 2
Standard Deviation 10.76
|
18.3 percentage of PI scores of >= 2
Standard Deviation 9.55
|
Adverse Events
Negative Control (W002194-221P)
19292-116A
11965-059
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Lynch, DMD, PhD/Study Director
Johnson & Johnson Consumer and Personal Products Worldwide
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigator agreed not to publish the study results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER