A Study of Virtually Supervised Mouthwash and Interdental Brushes

Study Overview
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Brief Summary
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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.

Official Title
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Six Month Clinical Efficacy of Virtually Supervised Mouthwash and Interdental Brushes: Effect on Plaque, Gingivitis and Oral Microbiome

Conditions
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Healthy

Intervention / Treatment
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* Drug: Colgate Cavity Protection Toothpaste
* Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT
* Drug: LISTERINE COOL MINT Antiseptic Mouthwash
* Device: TePe Original Interdental Brush


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 has been informed of all pertinent aspects of the trial Able to read and understand (participants capable of reading the documents) Able to schedule once daily virtual session during weekdays during the first three months of the study (up to visit 3) and then three times a week for the remainder of the study for interdental brush use and rinsing in real time via a platform such as Zoom, Facetime, Google Meet, Etcetera (etc) Adequate oral hygiene (that is, brush teeth daily and exhibit no signs or oral neglect) Males and females in good general and oral health without any known allergy to commercial dental products or cosmetics Evidence of being fully vaccinated for corona virus disease-2019 (COVID-19) (adults 60 years and older) Negative pregnancy urine tests (females of childbearing 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 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 Participants should have a minimum of 20 interproximal areas where interdental brushes can be inserted All interproximal sites must be able to accommodate an interdental brush A minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI) Participants will have evidence of some gingivitis (mild to severe); there will be no minimum or maximum mean Modified Gingival Index (MGI) score for gingivitis or Turesky Modification of the Quigley Hein Plaque Index (TPI) score for plaque No more than 3 sites having pocket depths of 5 millimeters (mm) and no sites that are greater than 5 mm in depth 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 advanced periodontitis based on a clinical examination at baseline and discretion of the dental examiner Absence of dental implants, fixed or removable orthodontic appliance or removable partial dentures or other appliances which may interfere with supervised interdental brushing Exclusion Criteria: History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; 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 Dental prophylaxis within four weeks prior to baseline visit History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouthwashes and toothpastes within four weeks prior to baseline Regular consumption of probiotic drinks/supplements within one week prior to screening/baseline; 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 participant's 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 1 or 2 diabetes mellitus) Participation in any clinical trial within 30 days of baseline visit 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 COVID-19 restrictions: Participants who fail to meet the criteria of the site's screening consent for preventing Infection in the site's COVID-19 consent form

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Brush Only<br>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. | Drug: Colgate Cavity Protection Toothpaste<br>* Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.<br>|
| Experimental: Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)<br>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. | Drug: Colgate Cavity Protection Toothpaste<br>* Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.<br>Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT<br>* Participants will use LISTERINE ZERO Alcohol Mouthwash COOL MINT for 30 second after brushing teeth twice daily.<br>|
| Experimental: Interdental Brush/Brush<br>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. | Drug: Colgate Cavity Protection Toothpaste<br>* Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.<br>Device: TePe Original Interdental Brush<br>* Participants will use Interdental Brush according to their personalized mouth map once daily in the morning.<br>|
| Experimental: Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)<br>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. | Drug: Colgate Cavity Protection Toothpaste<br>* Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.<br>Drug: LISTERINE COOL MINT Antiseptic Mouthwash<br>* Participants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily.<br>Device: TePe Original Interdental Brush<br>* Participants will use Interdental Brush according to their personalized mouth map once daily in the morning.<br>|
| Experimental: Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)<br>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. | Drug: Colgate Cavity Protection Toothpaste<br>* Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.<br>Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT<br>* Participants will use LISTERINE ZERO Alcohol Mouthwash COOL MINT for 30 second after brushing teeth twice daily.<br>Device: TePe Original Interdental Brush<br>* Participants will use Interdental Brush according to their personalized mouth map once daily in the morning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 |