A Phase 4 interventional study of Colgate (R) Cavity Protection Toothpaste and Colgate (R) Cello Toothbrush in Gingivitis and Plaque, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in Canada. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) (formerly part of Johnson & Johnson) · Phase 4, Interventional, and Other
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.
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 274 is above the median of 63 across 494 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 55 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
First submitted before Johnson & Johnson Consumer Inc. (J&JCI) left Johnson & Johnson.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Colgate (R) Cavity Protection Toothpaste · Device: Colgate (R) Cello Toothbrush · Other: Prototype 1 Mouthwash
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.
Other: Colgate (R) Cavity Protection Toothpaste · Device: Colgate (R) Cello Toothbrush · Other: Prototype 2 Mouthwash
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.
Other: Colgate (R) Cavity Protection Toothpaste · Device: Colgate (R) Cello Toothbrush · Other: Prototype 3 Mouthwash
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.
Other: Colgate (R) Cavity Protection Toothpaste · Device: Colgate (R) Cello Toothbrush · Other: Listerine (R) Cool Mint (R) Antiseptic Mouthwash
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.
Other: Colgate (R) Cavity Protection Toothpaste · Device: Colgate (R) Cello Toothbrush · Other: 5% Hydroalcohol Mouthwash
Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.
Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.
Participants will use 20 mL of Prototype 1 Mouthwash for 30 seconds after brushing twice daily.
Participants will use 20 mL of Prototype 2 Mouthwash for 30 seconds after brushing twice daily.
Participants will use 20 mL of Prototype 3 Mouthwash for 30 seconds after brushing twice daily.
Participants will use 20 mL of Listerine (R) Cool Mint (R) Antiseptic Mouthwash for 30 seconds after brushing twice daily.
Participants will use 20 mL of 5% Hydroalcohol Mouthwash for 30 seconds after brushing twice daily.
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.
Time frame: 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.
Time frame: After 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 4 and 12 weeks
Plan to share: Yes — 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.
Data sharing details ↗ · yoda.yale.edu
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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