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| ID | Type | Description | Link |
|---|---|---|---|
| CCSORC004843 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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The purpose of this study is to assess the relative effectiveness of oral (mouth) care regimens for the avoidance and treatment of plaque and gingivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brush Only | Other | Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes under virtual supervision in the morning. At home, participants will brush a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary. |
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| Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) | Experimental | Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINE ZERO Alcohol Mouthwash COOL MINT under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary. |
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| Interdental Brush/Brush | Experimental | Participants will use their interdental brush according to their personalized "mouth map", rinse with water then brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes under virtual supervision in the morning. At home, participants will brush a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Drug | Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Interproximal Mean Turesky Plaque Index (TPI) After 24 Weeks of Product Use | Interproximal mean TPI after 24 weeks of product use will be reported. 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 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). | After 24 weeks of product use |
| Interproximal Mean Modified Gingival Index (MGI) After 24 Weeks of Product Use | Interproximal mean MGI after 24 weeks of product use will be reported. 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 24 weeks of product use |
| Measure | Description | Time Frame |
|---|---|---|
| Interproximal Mean TPI after 4 and 12 Weeks | Interproximal mean TPI after 4 and 12 weeks will be reported. 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 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). |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12699051 | Background | Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167. | |
| 15127875 | Background | Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217. |
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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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| Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash) | Experimental | Participants will use their interdental brush according to their personalized "mouth map," rinse with water, brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINE COOL MINT Antiseptic Mouthwash under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary. |
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| Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) | Experimental | Participants will use their interdental brush according to their personalized "mouth map," rinse with water, brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINEZERO Alcohol Mouthwash COOL MINT under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary. |
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| LISTERINE ZERO Alcohol Mouthwash COOL MINT | Drug | Participants will use LISTERINE ZERO Alcohol Mouthwash COOL MINT for 30 second after brushing teeth twice daily. |
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| LISTERINE COOL MINT Antiseptic Mouthwash | Drug | Participants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily. |
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| TePe Original Interdental Brush | Device | Participants will use Interdental Brush according to their personalized mouth map once daily in the morning. |
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| After 4 and 12 weeks |
| Interproximal Mean MGI after 4 and 12 Weeks | Interproximal mean MGI after 4 and 12 weeks will be reported. 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 4 and 12 weeks |
| Interproximal Mean Expanded Bleeding Index (EBI) After 4, 12 and 24 Weeks | Interproximal mean EBI after 4, 12 and 24 weeks will be reported. 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). | After 4, 12 and 24 weeks |
| Interproximal Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks | Interproximal percent bleeding sites based on EBI after 4, 12 and 24 weeks will be reported. 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). | After 4, 12 and 24 weeks |
| Whole Mouth Mean TPI After 4, 12 and 24 Weeks | Whole mouth mean TPI after 4, 12 and 24 weeks will be reported. 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 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). | After 4, 12 and 24 weeks |
| Whole Mouth Mean MGI After 4, 12 and 24 Weeks | Whole mouth mean MGI after 4, 12 and 24 weeks will be reported. 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 4, 12 and 24 weeks |
| Whole Mouth Mean EBI After 4, 12 and 24 Weeks | Whole mouth mean EBI after 4, 12 and 24 weeks will be reported. 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). | After 4, 12 and 24 weeks |
| Whole Mouth Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks | Whole mouth percent bleeding sites based on EBI after 4, 12 and 24 weeks will be reported. 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). | After 4, 12 and 24 weeks |
| Marginal Mean TPI After 4, 12 and 24 Weeks | Marginal mean TPI after 4, 12 and 24 weeks will be reported. 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 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). | After 4, 12 and 24 weeks |
| Marginal Mean MGI After 4, 12 and 24 Weeks | Marginal mean MGI after 4, 12 and 24 weeks will be reported. 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 4, 12 and 24 weeks |
| Marginal Mean EBI After 4, 12 and 24 Weeks | Marginal mean EBI after 4, 12 and 24 weeks will be reported. 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). | After 4, 12 and 24 weeks |
| Whole Mouth and Interproximal Mean Pocket Depth After 12 and 24 Weeks | Whole mouth and interproximal mean pocket depth after 12 and 24 weeks will be reported. | After 12 and 24 weeks |
| Whole Mouth and Interproximal Mean Bleeding Upon Probing Pocket Depths After 12 and 24 Weeks | Whole mouth and interproximal mean bleeding upon probing pocket depths after 12 and 24 weeks will be reported. At each of the 6 sites (disto-facial, mid facial, mesio-facial, mesio-lingual, mid-lingual and disto-lingual), bleeding will be observed and scores as: 0=no bleeding and 1=bleeding. | After 12 and 24 weeks |
| Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) | Whole-mouth mean RMNPI will be reported. Supragingival plaque levels on the facial and lingual surfaces of all scorable teeth will be assessed according to the RMNPI. The facial and lingual surfaces will be divided into nine unequal segments (A, B, C, D, E, F, G, H and I) for a total of 18 sites per tooth that will be scored from 0 to 1, where 0=no plaque and 1=plaque present in the measured segment of the tooth. | Up to 24 weeks |
| Interproximal Mean RMNPI (Sites D and F) | Interproximal mean RMNPI (sites D and F) will be reported. Supragingival plaque levels on the facial and lingual surfaces of all scorable teeth will be assessed according to the RMNPI. The facial and lingual surfaces will be divided into nine unequal segments (A, B, C, D, E, F, G, H and I) for a total of 18 sites per tooth that will be scored from 0 to 1, where 0=no plaque and 1=plaque present in the measured segment of the tooth. | Up to 24 weeks |
| Expanded Interproximal Mean RMNPI (Sites D, F, A, and C) | Expanded interproximal mean RMNPI (Sites D, F, A, and C) will be reported. Supragingival plaque levels on the facial and lingual surfaces of all scorable teeth will be assessed according to the RMNPI. The facial and lingual surfaces will be divided into nine unequal segments (A, B, C, D, E, F, G, H and I) for a total of 18 sites per tooth that will be scored 0 to 1 where 0=no plaque and 1=plaque present in the measured segment of the tooth. | Up to 24 weeks |
| Observed Bacterial Species Richness As Assessed by Next Generation Deoxyribonucleic Acid (DNA) Sequencing | Observed bacterial species richness is measured from collected plaque specimens using Next-Generation DNA sequencing and counting the number of distinct bacterial species. Lower numbers represent scarcity of bacterial types while higher numbers represent large biodiversity of bacterial types detected in collected specimens. | At baseline, Weeks 4, 12 and 24 |
| Shannon-Weaver Diversity Index | The Shannon-Weaver diversity index will be reported for supragingival plaque assessment. | At baseline, Weeks 4, 12 and 24 |
| Total Species Microbial Load | Total species microbial load will be reported for supragingival plaque assessment. | At baseline, Weeks 4, 12 and 24 |
| Categorical Species Microbial Load | Categorical species microbial load will be reported for supragingival plaque assessment. | At baseline, Weeks 4, 12 and 24 |
| Individual Species Microbial Load | Individual species microbial load will be reported for supragingival plaque assessment. | At baseline, Weeks 4, 12 and 24 |
| Sample Clustering Analysis for Composition Change | Sample clustering analysis for composition change will be reported for supragingival plaque assessment. | At baseline, Weeks 4, 12 and 24 |
| Number of Total Bacteria and Select Species of Interest Expressed in Log10 | Quantification of live total bacteria and select species of interest in supra and sub-gingival plaque using viability quantitative polymerase chain reaction (qPCR) will be reported in Log10 bacterial cell number. | At Baseline and Week 24 |
| 12691269 | Background | Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5. |
| 35654566 | Background | Milleman K, Milleman J, Bosma ML, McGuire JA, Sunkara A, DelSasso A, York T, Cecil AM. Role of Manual Dexterity on Mechanical and Chemotherapeutic Oral Hygiene Regimens. J Dent Hyg. 2022 Jun;96(3):35-45. |
| 3485495 | Background | Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available. |
| 7806674 | Background | Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x. |
| 2524573 | Background | Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x. |
| 13809868 | Background | CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available. |
| 1306676 | Background | Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12. |
| 5264376 | Background | Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available. |
| Background | 11Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387. |