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| ID | Type | Description | Link |
|---|---|---|---|
| CCSORC004216 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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The purpose of this study is to evaluate the safety and efficacy of experimental mouthwash formulations compared to a hydroalcohol control mouthwash and a positive control mouthwash 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 |
|---|---|---|---|
| Prototype 1 Mouthwash | Experimental | Participants will brush their teeth using Colgate (registered [R]) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 milliliters (mL) of the Prototype 1 Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home. |
|
| Prototype 2 Mouthwash | Experimental | Participants will brush their teeth using Colgate (R) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Prototype 2 Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home. |
|
| Prototype 3 Mouthwash | Experimental | Participants will brush their teeth using Colgate (R) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Prototype 3 Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home. |
|
| Listerine (R) Cool Mint (R) Antiseptic Mouthwash (Positive Control) | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate (R) Cavity Protection Toothpaste | Other | Participants will use Colgate (R) 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 where 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 Turesky 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 1 mm 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 1mm), continuous band of plaque at the gingival margin; 3=band of plaque wider than 1 mm 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 |
|---|---|---|
| Chhaju Ram Goyal, DDS | All Sum Research Center Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Sum Research Center Ltd.; 6635 Kitimat Road, Units 36 & 37 | Mississauga | Ontario, Canada | L5N 6J2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26227646 | Background | Araujo MWB, Charles CA, Weinstein RB, McGuire JA, Parikh-Das AM, Du Q, Zhang J, Berlin JA, Gunsolley JC. Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque. J Am Dent Assoc. 2015 Aug;146(8):610-622. doi: 10.1016/j.adaj.2015.02.011. | |
| 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. |
| Label | URL |
|---|---|
| Twelve Week Safety/Clinical/Microbiological Efficacy of Experimental Mouthwashes | 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 |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| C057473 | Listerine |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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Participants will brush their teeth using Colgate (R) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Listerine Cool Mint Antiseptic Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
|
| 5 Percent (%) Hydroalcohol Mouthwash (Negative Control) | Active Comparator | Participants will brush their teeth using Colgate (R) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 mL of the 5% Hydroalcohol Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home. |
|
| Colgate (R) Cello Toothbrush | Device | Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily. |
|
| Prototype 1 Mouthwash | Other | Participants will use 20 mL of Prototype 1 Mouthwash for 30 seconds after brushing twice daily. |
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| Prototype 2 Mouthwash | Other | Participants will use 20 mL of Prototype 2 Mouthwash for 30 seconds after brushing twice daily. |
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| Prototype 3 Mouthwash | Other | Participants will use 20 mL of Prototype 3 Mouthwash for 30 seconds after brushing twice daily. |
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| Listerine (R) Cool Mint (R) Antiseptic Mouthwash | Other | Participants will use 20 mL of Listerine (R) Cool Mint (R) Antiseptic Mouthwash for 30 seconds after brushing twice daily. |
|
| 5% Hydroalcohol Mouthwash | Other | Participants will use 20 mL of 5% Hydroalcohol Mouthwash for 30 seconds after brushing twice daily. |
|
| After 1 and 4 weeks |
| 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 where 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 | 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. | 1, 4 and 12 weeks |
| Percentage of Bleeding Sites, Based on the EBI Score at 1, 4 and 12 Weeks | 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 0.5mm 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. | 1, 4 and 12 weeks |
| Log10 Transformed Total Bacterial Count After 4 and 12 Weeks of Product use | Log10 transformed total bacterial count will be assessed by quantitative polymerase chain reaction (qPCR) targeting the 16S recombinant deoxyribonucleic acid (rDNA) in six sampling sites in the mouth (saliva, tongue, buccal mucosa, gingiva, supragingival and subgingival plaque) after 4 and 12 weeks of product use. | After 4 and 12 weeks |
| Log10 Transformed Bacterial Counts After 4 and 12 Weeks of Product use | Log10 transformed bacterial counts of selected species of interest (including Fusobacterium nucleatum, Porphyromons gingivalis and Actinomyces oris) will be assessed by qPCR targeting the 16S rDNA in six sampling sites in the mouth (saliva, tongue, buccal mucosa, gingiva, supragingival and subgingival plaque) after 4 and 12 weeks of product use. | After 4 and 12 weeks |
| 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. |
| 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. |
| 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. |
| Background | Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387 |
| 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. |
| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |