HealthyPhase 4NCT05600231
A Study of Virtually Supervised Mouth Rinses and Flossing
A Phase 4 study testing LISTERINE COOL MINT Antiseptic Mouthwash, LISTERINE COOL MINT ZERO Alcohol Mouthwash and Reach Unflavored Waxed Dental Floss 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 evaluate the efficacy of brushing, flossing, and rinsing with essential oil mouth rinses; brushing and flossing; versus brushing and rinsing with essential oil mouth rinses; and brushing only for the prevention and reduction 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?
- LISTERINE COOL MINT Antiseptic Mouthwash, LISTERINE COOL MINT ZERO Alcohol Mouthwash and Reach Unflavored Waxed Dental Floss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 25 Jul 2022
- 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 participants 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 for flossing and rinsing in real time via a platform such as Zoom, Facetime, Google Meet, etc
- Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral neglect)
- Adults 18 years of age or older, in good general and oral health without any known allergy to commercial dental products or cosmetics
Show all 17Show fewer
- Evidence of being fully vaccinated for coronavirus 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
- A mean gingival index less than or equal to (<=) 0.75 per the Modified Gingival Index at baseline (healthy reference group)
- A minimum of 10 percent (%) bleeding sites based on the Expanded Bleeding Index (EBI) (randomized treatment groups)
- 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 (randomized treatment groups)
- No more than 3 sites having pocket depths of 5 mm and no sites that are greater than 5 millimeters (mm) in depth (randomized treatment groups)
- 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 and discretion of the dental examiner
- Absence of fixed or removable orthodontic appliance or removable partial dentures or other appliances which may interfere with flossing
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 screening/baseline visit
- History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- More than or equal to 3% bleeding sites at baseline (healthy reference group)
- Teeth having periodontal pocket depths measuring more than 3mm in depth (healthy reference group)
- 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
Show all 17Show fewer
- Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouth rinses and toothpastes within four weeks prior to the 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 the screening/baseline exam
- 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: Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque, Gingivitis, and Microbiome
The purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with essential oil mouth rinses; brushing and flossing; versus brushing and rinsing with essential oil mouth rinses; and brushing only for the prevention and reduction of plaque and gingivitis.
- Conditions
- Healthy
- Being tested
- LISTERINE COOL MINT Antiseptic Mouthwash, LISTERINE COOL MINT ZERO Alcohol Mouthwash, Reach Unflavored Waxed Dental Floss, Colgate Cavity Protection Toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LISTERINE COOL MINT Antiseptic MouthwashOther
Participants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily.
LISTERINE COOL MINT ZERO Alcohol MouthwashOther
Participants will use LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 second after brushing teeth twice daily.
Reach Unflavored Waxed Dental FlossOther
Participants after brushing for 1 timed minute, will rinse mouth with water and Floss once a day.
Colgate Cavity Protection ToothpasteOther
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group: Brush Only | Experimental | Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste for 1 timed minute under virtual supervision once daily during the week. At home, participants will brush a second time unsupervised daily in the evening and twice daily over weekends and holidays for 12 weeks. First product use will occur at the site under supervision. Receives: Other: Colgate Cavity Protection Toothpaste |
| Treatment Group: Brush / Rinse (LISTERINE COOL MINT Antiseptic Mouthwash) | Experimental | Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste once daily for 1 timed minute during the week under supervision and rinse with 20 milliliters (mL) of LISTERINE COOL MINT Antiseptic Mouthwash for 30 seconds. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for 12 weeks. First product use will occur at the site under supervision. Receives: Other: LISTERINE COOL MINT Antiseptic Mouthwash; Other: Colgate Cavity Protection Toothpaste |
| Treatment Group: Brush / Rinse LISTERINE COOL MINT ZERO Alcohol Mouthwash) | Experimental | Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste once daily for 1 timed minute during the week under supervision and rinse with 20 mL of LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 seconds. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for 12 weeks. First product use will occur at the site under supervision. Receives: Other: LISTERINE COOL MINT ZERO Alcohol Mouthwash; Other: Colgate Cavity Protection Toothpaste |
| Treatment Group: Brush / Floss | Experimental | Participants will brush their teeth using marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste for 1 timed minute and floss with Reach Unflavored Waxed Dental Floss under virtual supervision once daily during the week. At home, participants will brush a second time unsupervised daily in the evening. Over weekends and holidays, participants will brush and floss once daily. Only brushing will be performed a second time in the evening for 12 weeks. First product use will occur at the site under supervision. Receives: Other: Reach Unflavored Waxed Dental Floss; Other: Colgate Cavity Protection Toothpaste |
| Treatment Group: Brush / Floss / Rinse (LISTERINE COOL MINT ZERO Alcohol Mouthwash) | Experimental | Participants will brush their teeth using marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste for 1 timed minute, floss with Reach Unflavored Waxed Dental Floss and rinse with LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 seconds under virtual supervision once daily during the week. At home, participants will brush and rinse a second time unsupervised daily in the evening. Over weekends and holidays, participants will brush, floss and rinse once daily. Only brushing and rinsing will be performed a second time in the evening for 12 weeks. First product use will occur at the site under supervision. Receives: Other: LISTERINE COOL MINT ZERO Alcohol Mouthwash; Other: Reach Unflavored Waxed Dental Floss; Other: Colgate Cavity Protection Toothpaste |
| Healthy Reference Group | No intervention | Healthy participants will enroll in this reference group and will not receive any study product nor will they receive a prophylaxis as part of their participation in this study. The healthy reference group will be used as a comparator group for microbiome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interproximal Mean Turesky Plaque Index (TPI) After 12 Weeks of Product Use
Interproximal Mean TPI after 12 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 12 weeks
Interproximal Mean Modified Gingival Index (MGI) After 12 Weeks of Product Use
Interproximal Mean MGI after 12 weeks of product use will be reported. Gingivitis will be assessed by the Modified Gingival Index 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 12 weeks
Secondary outcomes (17)
Marginal Mean TPI After 4 and 12 Weeks
Marginal 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
Marginal Mean MGI After 4 and 12 Weeks
Marginal mean MGI after 4 and 12 weeks will be reported. Gingivitis will be assessed by the Modified Gingival Index 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
Marginal Mean Expanded Bleeding Index (EBI) After 4 and 12 Weeks
Marginal mean EBI after 4 and 12 weeks will be reported. Bleeding will be assessed according to the EBI, 168 Sites. A periodontal probe with a 0.5 millimeter (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 degree, 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 and 12 weeks
Interproximal Mean TPI After 4 Weeks
Interproximal mean TPI After 4 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 weeks
Interproximal Mean MGI After 4 Weeks
Interproximal mean MGI space after 4 weeks will be reported. Gingivitis will be assessed by the Modified Gingival Index 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: 4 weeks
Whole Mouth Mean TPI After 4 and 12 weeks
Whole mouth 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
Whole Mouth Mean MGI After 4 and 12 Weeks
Whole mouth mean MGI after 4 and 12 weeks will be reported. Gingivitis will be assessed by the Modified Gingival Index 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
Whole Mouth and Interproximal Mean EBI After 4 and 12 Weeks
Whole mouth and interproximal mean EBI After 4 and 12 Weeks will be reported. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, 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 and 12 weeks
Whole Mouth and Interproximal Percent Bleeding Sites After 4 and 12 Weeks based on EBI
Whole mouth and interproximal percent bleeding sites after 4 and 12 Weeks based on EBI will be reported. Percent bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, 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 and 12 weeks
Whole Mouth and Interproximal Mean Pocket Depth After 12 Weeks
Whole mouth and interproximal mean pocket depth after 12 weeks will be reported.
Measured: After 12 weeks
Whole Mouth and Interproximal Mean Bleeding Upon Probing Pocket Depths After 12 Weeks
Whole mouth and interproximal mean bleeding upon probing pocket depths after 12 weeks will be reported.
Measured: After 12 weeks
Shannon-Weaver Diversity Index
The Shannon-Weaver diversity index will be reported for supragingival plaque assessment.
Measured: At baseline and 4 and 12 weeks
Total Species Microbial Load
The total species microbial load will be reported for supragingival plaque assessment.
Measured: At baseline and 4 and 12 weeks
Categorical Species Microbial Load
The categorical species microbial load will be reported for supragingival plaque assessment.
Measured: At baseline and 4 and 12 weeks
Bacterial Species Richness
The observed bacterial species richness will be reported for supragingival plaque assessment.
Measured: At baseline and 4 and 12 weeks
Changes in Microbiome Composition by Multidimensional Reduction Analysis
Weighted UniFrac principal coordinates analysis (PCoA) analysis for the assessment of microbiome composition shift.
Measured: At baseline and 4 and 12 weeks
Number of Live Bacterial Counts Expressed in Log10
Quantification of live total bacteria and select species of interest in supragingival plaque using viability quantitative polymerase chain reaction (qPCR) and reported in Log10 bacterial cell number.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start18 Apr 2022
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 284 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
- NCT05600231
- Sponsor's protocol ID
- CCSORC004913
- Other IDs
- CCSORC004913
- Status last verified
- Jun 2023
- First submitted
- 26 Oct 2022
- Last updated
- 18 Jun 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 12691269Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.
Rich SK, Friedman JA, Schultz LA. Effects of flossing on plaque and gingivitis in third grade schoolchildren. J Public Health Dent. 1989 Spring;49(2):73-7. doi: 10.1111/j.1752-7325.1989.tb02029.x.
PubMed 2709366Van 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 13809868Lobene 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 3485495Turesky 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 5264376Min K, Bosma ML, John G, McGuire JA, DelSasso A, Milleman J, Milleman KR. Quantitative analysis of the effects of brushing, flossing, and mouthrinsing on supragingival and subgingival plaque microbiota: 12-week clinical trial. BMC Oral Health. 2024 May 17;24(1):575. doi: 10.1186/s12903-024-04362-y.
PubMed 38760758Bosma ML, McGuire JA, DelSasso A, Milleman J, Milleman K. Efficacy of flossing and mouth rinsing regimens on plaque and gingivitis: a randomized clinical trial. BMC Oral Health. 2024 Feb 3;24(1):178. doi: 10.1186/s12903-024-03924-4.
PubMed 38310236
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque, Gingivitis, and Microbiome
- ClinicalTrials.gov ID
- NCT05600231
- Acronym / sponsor ID
- CCSORC004913
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 31 Oct 2022 (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 evaluate the efficacy of brushing, flossing, and rinsing with essential oil mouth rinses; brushing and flossing; versus brushing and rinsing with essential oil mouth rinses; and brushing only for the prevention and reduction of plaque and gingivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Group: Brush Only | Experimental | Other: Colgate Cavity Protection ToothpasteParticipants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste for 1 timed minute under virtual supervision once daily during the week. At home, participants will brush a second time unsupervised daily in the evening and twice daily over weekends and holidays for 12 weeks. First product use will occur at the site under supervision. |
| Treatment Group: Brush / Rinse (LISTERINE COOL MINT Antiseptic Mouthwash) | Experimental | Other: LISTERINE COOL MINT Antiseptic Mouthwash, Other: Colgate Cavity Protection ToothpasteParticipants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste once daily for 1 timed minute during the week under supervision and rinse with 20 milliliters (mL) of LISTERINE COOL MINT Antiseptic Mouthwash for 30 seconds. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for 12 weeks. First product use will occur at the site under supervision. |
| Treatment Group: Brush / Rinse LISTERINE COOL MINT ZERO Alcohol Mouthwash) | Experimental | Other: LISTERINE COOL MINT ZERO Alcohol Mouthwash, Other: Colgate Cavity Protection ToothpasteParticipants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste once daily for 1 timed minute during the week under supervision and rinse with 20 mL of LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 seconds. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for 12 weeks. First product use will occur at the site under supervision. |
| Treatment Group: Brush / Floss | Experimental | Other: Reach Unflavored Waxed Dental Floss, Other: Colgate Cavity Protection ToothpasteParticipants will brush their teeth using marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste for 1 timed minute and floss with Reach Unflavored Waxed Dental Floss under virtual supervision once daily during the week. At home, participants will brush a second time unsupervised daily in the evening. Over weekends and holidays, participants will brush and floss once daily. Only brushing will be performed a second time in the evening for 12 weeks. First product use will occur at the site under supervision. |
| Treatment Group: Brush / Floss / Rinse (LISTERINE COOL MINT ZERO Alcohol Mouthwash) | Experimental | Other: LISTERINE COOL MINT ZERO Alcohol Mouthwash, Other: Reach Unflavored Waxed Dental Floss, Other: Colgate Cavity Protection ToothpasteParticipants will brush their teeth using marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste for 1 timed minute, floss with Reach Unflavored Waxed Dental Floss and rinse with LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 seconds under virtual supervision once daily during the week. At home, participants will brush and rinse a second time unsupervised daily in the evening. Over weekends and holidays, participants will brush, floss and rinse once daily. Only brushing and rinsing will be performed a second time in the evening for 12 weeks. First product use will occur at the site under supervision. |
| Healthy Reference Group | No intervention | –Healthy participants will enroll in this reference group and will not receive any study product nor will they receive a prophylaxis as part of their participation in this study. The healthy reference group will be used as a comparator group for microbiome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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 participants 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 for flossing and rinsing in real time via a platform such as Zoom, Facetime, Google Meet, etc
- Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral neglect)
Key exclusion criteria (17 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 screening/baseline visit
- History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- More than or equal to 3% bleeding sites at baseline (healthy reference group)
- Teeth having periodontal pocket depths measuring more than 3mm in depth (healthy reference group)
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 |
|---|---|---|
| LISTERINE COOL MINT Antiseptic MouthwashParticipants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily. | Other | Treatment Group: Brush / Rinse (LISTERINE COOL MINT Antiseptic Mouthwash) |
| LISTERINE COOL MINT ZERO Alcohol MouthwashParticipants will use LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 second after brushing teeth twice daily. | Other | Treatment Group: Brush / Floss / Rinse (LISTERINE COOL MINT ZERO Alcohol Mouthwash), Treatment Group: Brush / Rinse LISTERINE COOL MINT ZERO Alcohol Mouthwash) |
| Reach Unflavored Waxed Dental FlossParticipants after brushing for 1 timed minute, will rinse mouth with water and Floss once a day. | Other | Treatment Group: Brush / Floss, Treatment Group: Brush / Floss / Rinse (LISTERINE COOL MINT ZERO Alcohol Mouthwash) |
| Colgate Cavity Protection ToothpasteParticipants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily. | Other | Treatment Group: Brush / Floss, Treatment Group: Brush / Floss / Rinse (LISTERINE COOL MINT ZERO Alcohol Mouthwash), Treatment Group: Brush / Rinse (LISTERINE COOL MINT Antiseptic Mouthwash), Treatment Group: Brush / Rinse LISTERINE COOL MINT ZERO Alcohol Mouthwash), Treatment Group: Brush Only |
Primary outcome
Interproximal Mean Turesky Plaque Index (TPI) After 12 Weeks of Product Use
Time frame: After 12 weeks
Interproximal Mean TPI after 12 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 12 Weeks of Product Use
Time frame: After 12 weeks
Interproximal Mean MGI after 12 weeks of product use will be reported. Gingivitis will be assessed by the Modified Gingival Index 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).
17 secondary outcomes
Marginal Mean TPI After 4 and 12 Weeks
Time frame: After 4 and 12 weeks
Marginal Mean MGI After 4 and 12 Weeks
Time frame: After 4 and 12 weeks
Marginal Mean Expanded Bleeding Index (EBI) After 4 and 12 Weeks
Time frame: After 4 and 12 weeks
Interproximal Mean TPI After 4 Weeks
Time frame: After 4 weeks
Interproximal Mean MGI After 4 Weeks
Time frame: 4 weeks
Whole Mouth Mean TPI After 4 and 12 weeks
Time frame: After 4 and 12 weeks
Whole Mouth Mean MGI After 4 and 12 Weeks
Time frame: After 4 and 12 weeks
Whole Mouth and Interproximal Mean EBI After 4 and 12 Weeks
Time frame: After 4 and 12 weeks
Whole Mouth and Interproximal Percent Bleeding Sites After 4 and 12 Weeks based on EBI
Time frame: After 4 and 12 weeks
Whole Mouth and Interproximal Mean Pocket Depth After 12 Weeks
Time frame: After 12 weeks
Whole Mouth and Interproximal Mean Bleeding Upon Probing Pocket Depths After 12 Weeks
Time frame: After 12 weeks
Shannon-Weaver Diversity Index
Time frame: At baseline and 4 and 12 weeks
Total Species Microbial Load
Time frame: At baseline and 4 and 12 weeks
Categorical Species Microbial Load
Time frame: At baseline and 4 and 12 weeks
Bacterial Species Richness
Time frame: At baseline and 4 and 12 weeks
Changes in Microbiome Composition by Multidimensional Reduction Analysis
Time frame: At baseline and 4 and 12 weeks
Number of Live Bacterial Counts Expressed in Log10
Time frame: Up to 12 weeks
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 18 Jun 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.
- BackgroundNewman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.
- Background: PubMed 2709366Rich SK, Friedman JA, Schultz LA. Effects of flossing on plaque and gingivitis in third grade schoolchildren. J Public Health Dent. 1989 Spring;49(2):73-7. doi: 10.1111/j.1752-7325.1989.tb02029.x.
- 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 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 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.
- Derived from this study: PubMed 38760758Min K, Bosma ML, John G, McGuire JA, DelSasso A, Milleman J, Milleman KR. Quantitative analysis of the effects of brushing, flossing, and mouthrinsing on supragingival and subgingival plaque microbiota: 12-week clinical trial. BMC Oral Health. 2024 May 17;24(1):575. doi: 10.1186/s12903-024-04362-y.
- Derived from this study: PubMed 38310236Bosma ML, McGuire JA, DelSasso A, Milleman J, Milleman K. Efficacy of flossing and mouth rinsing regimens on plaque and gingivitis: a randomized clinical trial. BMC Oral Health. 2024 Feb 3;24(1):178. doi: 10.1186/s12903-024-03924-4.
- Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque, Gingivitis, and MicrobiomeLink provided by the sponsor.
- 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 LISTERINE COOL MINT Antiseptic Mouthwash, LISTERINE COOL MINT ZERO Alcohol Mouthwash and Reach Unflavored Waxed Dental Floss 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 17 inclusion and 17 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 18 Jun 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 12 Weeks of Product Use (time frame: After 12 weeks). 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 NCT05600231, which also lists 12 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 18 Jun 2023.