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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
192
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
Participants will use 20 mL of Zero Alcohol Gum Prototype Mouth Rinse for 30 seconds after brushing twice daily.
Participants will use 20 mL of Alcohol Gum Prototype Mouth Rinse for 30 seconds after brushing twice daily.
Salus Research, Inc.
Fort Wayne, Indiana, United States
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).
Time frame: 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).
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 \[up to 1 mm\], 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).
Time frame: After Weeks 1 and 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will use 20 mL of Listerine Cool Mint Mouth Rinse for 30 seconds after brushing twice daily.
Participants will use 20 mL of 5% Hydroalcohol Mouth Rinse for 30 seconds after brushing twice daily.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At Baseline and 1, 4, and 12 weeks
Shannon-weaver Diversity Index
The Shannon-Weaver diversity index will be reported for supragingival plaque assessment.
Time frame: At Baseline and 1, 4, and 12 weeks
Total Species Microbial Load
The total species microbial load will be reported for supragingival plaque assessment.
Time frame: At Baseline and 1, 4, and 12 weeks
Categorical Species Microbial Load
The categorical species microbial load will be reported for supragingival plaque assessment.
Time frame: 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.
Time frame: 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.
Time frame: At Baseline and After 12 weeks