A Study of Experimental Mouthwashes

Study Overview
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Brief Summary
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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.

Official Title
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Twelve Week Safety/Clinical/Microbiological Efficacy of Experimental Mouthwashes

Conditions
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Gingivitis, Plaque

Intervention / Treatment
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* Other: Colgate (R) Cavity Protection Toothpaste
* Device: Colgate (R) Cello Toothbrush
* Other: Prototype 1 Mouthwash
* Other: Prototype 2 Mouthwash
* Other: Prototype 3 Mouthwash
* Other: Listerine (R) Cool Mint (R) Antiseptic Mouthwash
* Other: 5% Hydroalcohol Mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment Evidence of a personally signed and dated informed consent document indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial Able to read and understand the local language (participant is capable of reading the documents) Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral neglect) Adults, 18 to 59 years of age, in good general and oral health without any known allergy to commercial dental products or cosmetics Negative pregnancy urine tests (females of child-bearing potential only) Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study (men do not have to use a medically acceptable method of birth control before or during the study) A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count A mean gingival index greater than or equal to (>=) 1.95 per the modified gingival index at baseline A mean plaque index >= 1.95 per the 6 site turesky modification of the quigley-hein plaque index at baseline Greater than or equal to 10 percent (%) bleeding sites at baseline Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator Absence of moderate/advanced periodontitis based on a clinical examination and discretion of the dental examiner Absence of fixed or removable orthodontic appliance or removable partial dentures Exclusion Criteria: History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouthwashes and red food dye Dental prophylaxis within four weeks prior to Baseline visit More than three sites that have periodontal pockets depths measuring 5 millimeters (mm) in depth History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication (ibuprofen, aspirin) is acceptable at the discretion of the investigator Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, sodium fluoride with Cetylpyridinium chloride (CPC), stannous fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes within the four weeks prior to the baseline exam Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products) Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results) Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage Suspected alcohol or substance abuse (example, amphetamines, benzodiazepines, cocaine, marijuana, opiates) Significant unstable or uncontrolled medical condition which may interfere with a participants participation in the study, including cancer, chronic kidney disease, chronic obstructive pulmonary disease (COPD), immunocompromised state (weakened immune system) from solid organ transplant, serious heart conditions, (such as heart failure, coronary artery disease, or cardiomyopathies) Sickle cell disease, Type 2 diabetes mellitus Participation in any clinical trial within 30 days of screening visit Diagnosed temporo-mandibular joint dysfunction/disorder Participants who wear bruxing devices, dental aligners, retainers Participants who were previously screened and ineligible or were randomized to receive investigational product Participants who are related to those persons involved directly or indirectly with the conduct of this study (that is, principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson & Johnson subsidiaries, contractors of Johnson & Johnson, and the families of each) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for entry into this study Coronavirus Disease 2019 (COVID-19) restrictions: a) History of a confirmed COVID-19 infection in the last 30 days; b) Contact with a COVID-19-infected person within 14 days prior to enrollment; c) Any international travel within 14 days prior to enrollment including members in the same household; d) Participants with self-reported symptoms within the past 2 weeks: i) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever or chest pain/tightness; ii) Temperature >= 38.0 degree Celsius (°C)/100.4 degree Fahrenheit (°F), measured by thermometer which is adjusted for core temperature; iii) Use of fever reducers within the past 2 days of each onsite visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prototype 1 Mouthwash<br>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<br>* Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.<br>Device: Colgate (R) Cello Toothbrush<br>* Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.<br>Other: Prototype 1 Mouthwash<br>* Participants will use 20 mL of Prototype 1 Mouthwash for 30 seconds after brushing twice daily.<br>|
| Experimental: Prototype 2 Mouthwash<br>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<br>* Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.<br>Device: Colgate (R) Cello Toothbrush<br>* Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.<br>Other: Prototype 2 Mouthwash<br>* Participants will use 20 mL of Prototype 2 Mouthwash for 30 seconds after brushing twice daily.<br>|
| Experimental: Prototype 3 Mouthwash<br>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<br>* Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.<br>Device: Colgate (R) Cello Toothbrush<br>* Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.<br>Other: Prototype 3 Mouthwash<br>* Participants will use 20 mL of Prototype 3 Mouthwash for 30 seconds after brushing twice daily.<br>|
| Active Comparator: Listerine (R) Cool Mint (R) Antiseptic Mouthwash (Positive Control)<br>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<br>* Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.<br>Device: Colgate (R) Cello Toothbrush<br>* Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.<br>Other: Listerine (R) Cool Mint (R) Antiseptic Mouthwash<br>* Participants will use 20 mL of Listerine (R) Cool Mint (R) Antiseptic Mouthwash for 30 seconds after brushing twice daily.<br>|
| Active Comparator: 5 Percent (%) Hydroalcohol Mouthwash (Negative Control)<br>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<br>* Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.<br>Device: Colgate (R) Cello Toothbrush<br>* Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.<br>Other: 5% Hydroalcohol Mouthwash<br>* Participants will use 20 mL of 5% Hydroalcohol Mouthwash for 30 seconds after brushing twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |