Six Month Clinical Efficacy of Virtually Supervised Mouthwash and Interdental Brushes: Effect on Plaque, Gingivitis and Oral Microbiome
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 292
- Locations
- 1
- Primary Endpoint
- Interproximal Mean Turesky Plaque Index (TPI) After 24 Weeks of Product Use
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Brush Only
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.
Intervention: Colgate Cavity Protection Toothpaste (Drug)
Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
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.
Intervention: Colgate Cavity Protection Toothpaste (Drug)
Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
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.
Intervention: LISTERINE ZERO Alcohol Mouthwash COOL MINT (Drug)
Interdental Brush/Brush
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.
Intervention: Colgate Cavity Protection Toothpaste (Drug)
Interdental Brush/Brush
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.
Intervention: TePe Original Interdental Brush (Device)
Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)
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.
Intervention: Colgate Cavity Protection Toothpaste (Drug)
Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)
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.
Intervention: LISTERINE COOL MINT Antiseptic Mouthwash (Drug)
Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)
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.
Intervention: TePe Original Interdental Brush (Device)
Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
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.
Intervention: Colgate Cavity Protection Toothpaste (Drug)
Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
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.
Intervention: LISTERINE ZERO Alcohol Mouthwash COOL MINT (Drug)
Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
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.
Intervention: TePe Original Interdental Brush (Device)
Outcomes
Primary Outcomes
Interproximal Mean Turesky Plaque Index (TPI) After 24 Weeks of Product Use
Time Frame: 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).
Interproximal Mean Modified Gingival Index (MGI) After 24 Weeks of Product Use
Time Frame: 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).
Secondary Outcomes
- Interproximal Mean TPI after 4 and 12 Weeks(After 4 and 12 weeks)
- Interproximal Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Total Species Microbial Load(At baseline, Weeks 4, 12 and 24)
- Interproximal Mean MGI after 4 and 12 Weeks(After 4 and 12 weeks)
- Whole Mouth Mean TPI After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Whole Mouth Mean MGI After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Marginal Mean TPI After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Shannon-Weaver Diversity Index(At baseline, Weeks 4, 12 and 24)
- Interproximal Mean Expanded Bleeding Index (EBI) After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Whole Mouth Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Marginal Mean MGI After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Whole Mouth and Interproximal Mean Pocket Depth After 12 and 24 Weeks(After 12 and 24 weeks)
- Whole Mouth and Interproximal Mean Bleeding Upon Probing Pocket Depths After 12 and 24 Weeks(After 12 and 24 weeks)
- Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI)(Up to 24 weeks)
- Interproximal Mean RMNPI (Sites D and F)(Up to 24 weeks)
- Categorical Species Microbial Load(At baseline, Weeks 4, 12 and 24)
- Number of Total Bacteria and Select Species of Interest Expressed in Log10(At Baseline and Week 24)
- Expanded Interproximal Mean RMNPI (Sites D, F, A, and C)(Up to 24 weeks)
- Whole Mouth Mean EBI After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Marginal Mean EBI After 4, 12 and 24 Weeks(After 4, 12 and 24 weeks)
- Observed Bacterial Species Richness As Assessed by Next Generation Deoxyribonucleic Acid (DNA) Sequencing(At baseline, Weeks 4, 12 and 24)
- Individual Species Microbial Load(At baseline, Weeks 4, 12 and 24)
- Sample Clustering Analysis for Composition Change(At baseline, Weeks 4, 12 and 24)