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A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02233998
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : July 28, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator)
Conditions Plaque
Gingivitis
Interventions Other: Mouth Rinse 1
Other: Mouth Rinse 2
Other: Mouth Rinse 3
Enrollment 158
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Period Title: Overall Study
Started 53 52 53
Completed 53 52 53
Not Completed 0 0 0
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059 Total
Hide Arm/Group Description Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing Total of all reporting groups
Overall Number of Baseline Participants 53 52 53 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 52 participants 53 participants 158 participants
46.2  (10.97) 41.7  (12.48) 45.5  (11.18) 44.5  (11.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 52 participants 53 participants 158 participants
Female
39
  73.6%
29
  55.8%
32
  60.4%
100
  63.3%
Male
14
  26.4%
23
  44.2%
21
  39.6%
58
  36.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 53 participants 52 participants 53 participants 158 participants
53 52 53 158
1.Primary Outcome
Title Whole Mouth Mean Modified Gingival Index (MGI) at Week 3
Hide Description 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.
Time Frame 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.004  (0.0114) 1.770  (0.0115) 1.807  (0.0113)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.
Method ANCOVA
Comments Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.234
Confidence Interval (2-Sided) 95%
-0.266 to -0.202
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0162
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.
Method ANCOVA
Comments Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.197
Confidence Interval (2-Sided) 95%
-0.228 to -0.165
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0161
Estimation Comments [Not Specified]
2.Primary Outcome
Title Whole Mouth Mean Plaque Index (PI) at Week 3
Hide Description 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.
Time Frame 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.434  (0.0202) 1.965  (0.0204) 2.055  (0.0202)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.
Method ANCOVA
Comments Terms included treatment with baseline whole mouth mean plaque index as a covariate.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.469
Confidence Interval (2-Sided) 95%
-0.526 to -0.413
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0286
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.
Method ANCOVA
Comments Terms included treatment with baseline whole mouth mean plaque index as a covariate.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.379
Confidence Interval (2-Sided) 95%
-0.435 to -0.322
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0286
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3
Hide Description 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.
Time Frame 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.098  (0.0042) 0.067  (0.0042) 0.072  (0.0042)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.030
Confidence Interval (2-Sided) 95%
-0.042 to -0.019
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0060
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method ANCOVA
Comments Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.026
Confidence Interval (2-Sided) 95%
-0.038 to -0.014
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0059
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3
Hide Description 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.
Time Frame Baseline to 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Mean (Standard Deviation)
Unit of Measure: percentage of MGI scores of 0 or 1
5.5  (4.52) 27.5  (9.45) 24.3  (8.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 23.240
Confidence Interval (2-Sided) 95%
20.75 to 25.85
Estimation Comments 95% Confidence limits for the location shift.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 19.444
Confidence Interval (2-Sided) 95%
17.09 to 22.22
Estimation Comments 95% Confidence limits for the location shift.
5.Secondary Outcome
Title Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3
Hide Description 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.
Time Frame Baseline to 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Mean (Standard Deviation)
Unit of Measure: percentage of PI scores of 0 or 1
3.2  (3.60) 20.9  (10.76) 18.3  (9.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 19.048
Confidence Interval (2-Sided) 95%
15.94 to 21.73
Estimation Comments 95% Confidence limits for the location shift.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 15.939
Confidence Interval (2-Sided) 95%
12.50 to 18.67
Estimation Comments 95% Confidence limits for the location shift.
6.Secondary Outcome
Title Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3
Hide Description 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.
Time Frame Baseline to 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Mean (Standard Deviation)
Unit of Measure: percentage of BI scores of 0
0.3  (2.30) 2.5  (2.66) 2.1  (3.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 2.050
Confidence Interval (2-Sided) 95%
1.30 to 2.78
Estimation Comments 95% Confidence limits for the location shift.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 1.190
Confidence Interval (2-Sided) 95%
0.93 to 2.06
Estimation Comments 95% Confidence limits for the location shift.
7.Secondary Outcome
Title Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3
Hide Description 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.
Time Frame Baseline to 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Mean (Standard Deviation)
Unit of Measure: percentage of MGI scores of >= 3
-0.6  (4.34) 0.9  (4.15) 0.3  (3.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 1.316
Confidence Interval (2-Sided) 95%
0.00 to 2.78
Estimation Comments 95% Confidence limits for the location shift.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.197
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 0.926
Confidence Interval (2-Sided) 95%
-0.16 to 1.85
Estimation Comments 95% Confidence limits for the location shift.
8.Secondary Outcome
Title Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3
Hide Description 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.
Time Frame Baseline to 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Mean (Standard Deviation)
Unit of Measure: percentage of PI scores of >= 3
0.1  (13.12) 23.5  (14.45) 18.9  (13.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 23.214
Confidence Interval (2-Sided) 95%
18.21 to 28.77
Estimation Comments 95% Confidence limits for the location shift.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 18.590
Confidence Interval (2-Sided) 95%
13.69 to 23.81
Estimation Comments 95% Confidence limits for the location shift.
9.Secondary Outcome
Title Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3
Hide Description 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.
Time Frame Baseline to 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description:
Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
Overall Number of Participants Analyzed 53 52 53
Mean (Standard Deviation)
Unit of Measure: percentage of PI scores of >= 2
3.2  (3.60) 20.9  (10.76) 18.3  (9.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 19292-116A
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 19.048
Confidence Interval (2-Sided) 95%
15.94 to 21.73
Estimation Comments 95% Confidence limits for the location shift.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Negative Control (W002194-221P), 11965-059
Comments The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.
Method Wilcoxon Rank Sum Test
Comments P-values were based on Wilcoxon Rank Sum Test on the change from baseline.
Method of Estimation Estimation Parameter Hodges-Lehmann estimate of difference
Estimated Value 15.939
Confidence Interval (2-Sided) 95%
12.50 to 18.67
Estimation Comments 95% Confidence limits for the location shift.
Time Frame Day 22 ± 2 days, + 30 days for serious adverse events.
Adverse Event Reporting Description Adverse events were systematically collected at each study visit through Visit 3 (Day 22 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
 
Arm/Group Title Negative Control (W002194-221P) 19292-116A 11965-059
Hide Arm/Group Description Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
All-Cause Mortality
Negative Control (W002194-221P) 19292-116A 11965-059
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Negative Control (W002194-221P) 19292-116A 11965-059
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/52 (0.00%)   0/53 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Negative Control (W002194-221P) 19292-116A 11965-059
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/52 (0.00%)   0/53 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal investigator agreed not to publish the study results without prior sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Lynch, DMD, PhD/Study Director
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 908-433-6423 USA EST
EMail: mlynch23@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT02233998    
Other Study ID Numbers: CO-140508133810-OCCT
First Submitted: September 4, 2014
First Posted: September 9, 2014
Results First Submitted: June 29, 2015
Results First Posted: July 28, 2015
Last Update Posted: August 21, 2015