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| ID | Type | Description | Link |
|---|---|---|---|
| CCSORC005014 | Other Identifier | Johnson & Johnson Consumer Inc. |
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The purpose of this study is to evaluate the safety and efficacy of two essential oil containing experimental mouth rinse formulations and an essential oil containing mouth rinse compared to a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a twelve-week product usage period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero Alcohol Gum Prototype | Experimental | Participants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 milliliters (mL) of the Zero Alcohol Gum Prototype Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home. |
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| Alcohol Gum Prototype | Experimental | Participants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Alcohol Gum Prototype Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home. |
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| Listerine Cool Mint Antiseptic Mouthwash | Experimental | Participants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Listerine Cool Mint Mouth rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home. |
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| Negative Control: 5 percent (%) Hydroalcohol | Active Comparator | Participants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the 5% Hydroalcohol Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Other | Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use | Gingivitis will be assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit). | After 12 weeks |
| Whole-mouth Mean Plaque Index (TPI) Score After 12 Weeks of Product use | Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around 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 than 1/3 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). | After 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Whole-mouth Mean TPI Score After 1 and 4 Weeks of Product use | Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around 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 than 1/3 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Milleman, DDS | Salus Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | 46825 | United States |
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| Label | URL |
|---|---|
| Twelve Week Safety, Clinical, and Microbiological Efficacy of Experimental Zinc Containing Mouth Rinses | View source |
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Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Zero Alcohol Gum Prototype | Other | Participants will use 20 mL of Zero Alcohol Gum Prototype Mouth Rinse for 30 seconds after brushing twice daily. |
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| Alcohol Gum Prototype | Other | Participants will use 20 mL of Alcohol Gum Prototype Mouth Rinse for 30 seconds after brushing twice daily. |
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| Listerine Cool Mint Antiseptic Mouthwash | Other | Participants will use 20 mL of Listerine Cool Mint Mouth Rinse for 30 seconds after brushing twice daily. |
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| 5% Hydroalcohol | Other | Participants will use 20 mL of 5% Hydroalcohol Mouth Rinse for 30 seconds after brushing twice daily. |
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| After Weeks 1 and 4 |
| Whole-mouth Mean MGI Score After 1 and 4 Weeks of Product Use | Gingivitis will be assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit). | After 1 and 4 weeks |
| Whole-Mouth Mean Expanded Gingival Bleeding Index (EBI) Score at 1, 4 and 12 Weeks of Product use | Bleeding will be assessed according to the EBI, 168 Sites. A periodontal probe with a 0.5 mm diameter tip will be 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 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding). | Weeks 1, 4 and 12 |
| Percentage of Bleeding Sites, Based on the EBI Score at 1, 4, and 12 Weeks of Product use | Percentage of bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 mm diameter tip will be 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 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding). | After 1, 4, and Week 12 |
| Whole Mouth Bleeding on Probing Depth at 12 Week | Whole mouth bleeding on probing depth at 12 week will be reported. | At Week 12 |
| Number of Distinct Bacterial Species | The number of distinct bacterial species identified on supragingival plaque using microbiome profiling will be reported at baseline, 1 week, 4 weeks and 12 weeks. | At Baseline and 1, 4, and 12 weeks |
| Shannon-weaver Diversity Index | The Shannon-Weaver diversity index will be reported for supragingival plaque assessment. | At Baseline and 1, 4, and 12 weeks |
| Total Species Microbial Load | The total species microbial load will be reported for supragingival plaque assessment. | At Baseline and 1, 4, and 12 weeks |
| Categorical Species Microbial Load | The categorical species microbial load will be reported for supragingival plaque assessment. | At Baseline and 1, 4, and 12 weeks |
| Changes in Microbiome Composition by Sample Clustering Analysis | Clustering analysis in microbiome profiling is a multidimensional reduction analysis for the assessment of microbiome composition shift. | At Baseline and 1, 4, and 12 weeks |
| Number of Live Bacterial Counts Expressed in Log10 | The number of live bacterial counts (expressed in log10) on supragingival and subgingival plaque will be reported at baseline and 12 weeks using viability quantitative polymerase chain reaction (qPCR) targeting total bacteria, Fusobacterium nucleatum, Porphyromonas gingivalis and Actinomyces oris. | At Baseline and After 12 weeks |