HealthyPhase 4NCT05756673
A Study of Virtually Supervised Mouthwash and Interdental Brushes
A Phase 4 study testing Colgate Cavity Protection Toothpaste, LISTERINE ZERO Alcohol Mouthwash COOL MINT and LISTERINE COOL MINT Antiseptic Mouthwash in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Colgate Cavity Protection Toothpaste, LISTERINE ZERO Alcohol Mouthwash COOL MINT and LISTERINE COOL MINT Antiseptic Mouthwash
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 3 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Six Month Clinical Efficacy of Virtually Supervised Mouthwash and Interdental Brushes: Effect on Plaque, Gingivitis and Oral Microbiome
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.
- Conditions
- Healthy
- Being tested
- Colgate Cavity Protection Toothpaste, LISTERINE ZERO Alcohol Mouthwash COOL MINT, LISTERINE COOL MINT Antiseptic Mouthwash, TePe Original Interdental Brush
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate Cavity Protection ToothpasteDrug
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
LISTERINE ZERO Alcohol Mouthwash COOL MINTDrug
Participants will use LISTERINE ZERO Alcohol Mouthwash COOL MINT for 30 second after brushing teeth twice daily.
LISTERINE COOL MINT Antiseptic MouthwashDrug
Participants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily.
TePe Original Interdental BrushDevice
Participants will use Interdental Brush according to their personalized mouth map once daily in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Brush Only | Other | 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. Receives: Drug: Colgate Cavity Protection Toothpaste |
| Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) | Experimental | 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. Receives: Drug: Colgate Cavity Protection Toothpaste; Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT |
| Interdental Brush/Brush | Experimental | 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. Receives: Drug: Colgate Cavity Protection Toothpaste; Device: TePe Original Interdental Brush |
| Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash) | Experimental | 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. Receives: Drug: Colgate Cavity Protection Toothpaste; Drug: LISTERINE COOL MINT Antiseptic Mouthwash; Device: TePe Original Interdental Brush |
| Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) | Experimental | 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. Receives: Drug: Colgate Cavity Protection Toothpaste; Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT; Device: TePe Original Interdental Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: After 24 weeks of product use
Secondary outcomes (23)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, Weeks 4, 12 and 24
Shannon-Weaver Diversity Index
The Shannon-Weaver diversity index will be reported for supragingival plaque assessment.
Measured: At baseline, Weeks 4, 12 and 24
Total Species Microbial Load
Total species microbial load will be reported for supragingival plaque assessment.
Measured: At baseline, Weeks 4, 12 and 24
Categorical Species Microbial Load
Categorical species microbial load will be reported for supragingival plaque assessment.
Measured: At baseline, Weeks 4, 12 and 24
Individual Species Microbial Load
Individual species microbial load will be reported for supragingival plaque assessment.
Measured: 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.
Measured: 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.
Measured: At Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start9 Feb 2023
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Milleman, DDS, Principal investigator, Salus Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756673
- Sponsor's protocol ID
- CCSORC004843
- Other IDs
- CCSORC004843
- Status last verified
- Oct 2023
- First submitted
- 7 Feb 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.
PubMed 12699051Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217.
PubMed 15127875Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.
PubMed 12691269Milleman K, Milleman J, Bosma ML, McGuire JA, Sunkara A, DelSasso A, York T, Cecil AM. Role of Manual Dexterity on Mechanical and Chemotherapeutic Oral Hygiene Regimens. J Dent Hyg. 2022 Jun;96(3):35-45.
PubMed 35654566Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
PubMed 3485495Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
PubMed 7806674Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x.
PubMed 2524573CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available.
PubMed 13809868Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12.
PubMed 1306676Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
PubMed 526437611Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Month Clinical Efficacy of Virtually Supervised Mouthwash and Interdental Brushes: Effect on Plaque, Gingivitis and Oral Microbiome
- ClinicalTrials.gov ID
- NCT05756673
- Acronym / sponsor ID
- CCSORC004843
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Brush Only | Other | Drug: Colgate Cavity Protection ToothpasteParticipants 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. |
| Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) | Experimental | Drug: Colgate Cavity Protection Toothpaste, Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINTParticipants 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. |
| Interdental Brush/Brush | Experimental | Drug: Colgate Cavity Protection Toothpaste, Device: TePe Original Interdental BrushParticipants 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. |
| Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash) | Experimental | Drug: Colgate Cavity Protection Toothpaste, Drug: LISTERINE COOL MINT Antiseptic Mouthwash, Device: TePe Original Interdental BrushParticipants 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. |
| Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) | Experimental | Drug: Colgate Cavity Protection Toothpaste, Drug: LISTERINE ZERO Alcohol Mouthwash COOL MINT, Device: TePe Original Interdental BrushParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colgate Cavity Protection ToothpasteParticipants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily. | Drug | Brush Only, Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT), Interdental Brush/Brush, Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash), Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) |
| LISTERINE ZERO Alcohol Mouthwash COOL MINTParticipants will use LISTERINE ZERO Alcohol Mouthwash COOL MINT for 30 second after brushing teeth twice daily. | Drug | Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT), Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) |
| LISTERINE COOL MINT Antiseptic MouthwashParticipants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily. | Drug | Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash) |
| TePe Original Interdental BrushParticipants will use Interdental Brush according to their personalized mouth map once daily in the morning. | Device | Interdental Brush/Brush, Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash), Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) |
Primary outcome
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).
23 secondary outcomes
Interproximal Mean TPI after 4 and 12 Weeks
Time frame: After 4 and 12 weeks
Interproximal Mean MGI after 4 and 12 Weeks
Time frame: After 4 and 12 weeks
Interproximal Mean Expanded Bleeding Index (EBI) After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Interproximal Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Whole Mouth Mean TPI After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Whole Mouth Mean MGI After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Whole Mouth Mean EBI After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Whole Mouth Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Marginal Mean TPI After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Marginal Mean MGI After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Marginal Mean EBI After 4, 12 and 24 Weeks
Time frame: After 4, 12 and 24 weeks
Whole Mouth and Interproximal Mean Pocket Depth After 12 and 24 Weeks
Time frame: After 12 and 24 weeks
Whole Mouth and Interproximal Mean Bleeding Upon Probing Pocket Depths After 12 and 24 Weeks
Time frame: After 12 and 24 weeks
Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI)
Time frame: Up to 24 weeks
Interproximal Mean RMNPI (Sites D and F)
Time frame: Up to 24 weeks
Expanded Interproximal Mean RMNPI (Sites D, F, A, and C)
Time frame: Up to 24 weeks
Observed Bacterial Species Richness As Assessed by Next Generation Deoxyribonucleic Acid (DNA) Sequencing
Time frame: At baseline, Weeks 4, 12 and 24
Shannon-Weaver Diversity Index
Time frame: At baseline, Weeks 4, 12 and 24
Total Species Microbial Load
Time frame: At baseline, Weeks 4, 12 and 24
Categorical Species Microbial Load
Time frame: At baseline, Weeks 4, 12 and 24
Individual Species Microbial Load
Time frame: At baseline, Weeks 4, 12 and 24
Sample Clustering Analysis for Composition Change
Time frame: At baseline, Weeks 4, 12 and 24
Number of Total Bacteria and Select Species of Interest Expressed in Log10
Time frame: At Baseline and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 12699051Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.
- Background: PubMed 15127875Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217.
- Background: PubMed 12691269Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.
- Background: PubMed 35654566Milleman K, Milleman J, Bosma ML, McGuire JA, Sunkara A, DelSasso A, York T, Cecil AM. Role of Manual Dexterity on Mechanical and Chemotherapeutic Oral Hygiene Regimens. J Dent Hyg. 2022 Jun;96(3):35-45.
- Background: PubMed 3485495Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
- Background: PubMed 7806674Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
- Background: PubMed 2524573Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x.
- Background: PubMed 13809868CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available.
- Background: PubMed 1306676Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12.
- Background: PubMed 5264376Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
- Background11Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Milleman, DDS principal investigator
Salus Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colgate Cavity Protection Toothpaste, LISTERINE ZERO Alcohol Mouthwash COOL MINT and LISTERINE COOL MINT Antiseptic Mouthwash in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interproximal Mean Turesky Plaque Index (TPI) After 24 Weeks of Product Use (time frame: After 24 weeks of product use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756673, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.