A Study of Virtually Supervised Mouth Rinses and Flossing
NCT ID: NCT05600231
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
284 participants
INTERVENTIONAL
2022-04-18
2022-07-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing
NCT04750005
A Twelve Week Study of Supervised Mouth Rinse and Flossing
NCT04696536
A Study of Virtually Supervised Mouthwash and Interdental Brushes
NCT05756673
A Twelve Week Study of Prototypes Mouth Rinses
NCT05526586
Comparative Efficacy of Floss and Essential Oil/CPC+Zn Mouthwashes in Reducing Dental Plaque and Gingivitis
NCT07029438
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Group: Brush Only
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.
Colgate Cavity Protection Toothpaste
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
Treatment Group: Brush / Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)
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.
LISTERINE COOL MINT Antiseptic Mouthwash
Participants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily.
Colgate Cavity Protection Toothpaste
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
Treatment Group: Brush / Rinse LISTERINE COOL MINT ZERO Alcohol Mouthwash)
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.
LISTERINE COOL MINT ZERO Alcohol Mouthwash
Participants will use LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 second after brushing teeth twice daily.
Colgate Cavity Protection Toothpaste
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
Treatment Group: Brush / Floss
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.
Reach Unflavored Waxed Dental Floss
Participants after brushing for 1 timed minute, will rinse mouth with water and Floss once a day.
Colgate Cavity Protection Toothpaste
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
Treatment Group: Brush / Floss / Rinse (LISTERINE COOL MINT ZERO Alcohol Mouthwash)
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.
LISTERINE COOL MINT ZERO Alcohol Mouthwash
Participants will use LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 second after brushing teeth twice daily.
Reach Unflavored Waxed Dental Floss
Participants after brushing for 1 timed minute, will rinse mouth with water and Floss once a day.
Colgate Cavity Protection Toothpaste
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
Healthy Reference Group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LISTERINE COOL MINT Antiseptic Mouthwash
Participants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily.
LISTERINE COOL MINT ZERO Alcohol Mouthwash
Participants will use LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 second after brushing teeth twice daily.
Reach Unflavored Waxed Dental Floss
Participants after brushing for 1 timed minute, will rinse mouth with water and Floss once a day.
Colgate Cavity Protection Toothpaste
Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffery Milleman, DDS
Role: PRINCIPAL_INVESTIGATOR
Salus Research, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Salus Research, Inc.
Fort Wayne, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Sharma 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.
Sharma 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.
Newman, 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.
Van 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.
Saxton 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.
CHILTON 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.
Lobene 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.
Turesky 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.
Min 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.
Bosma 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.
Related Links
Access external resources that provide additional context or updates about the study.
Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque, Gingivitis, and Microbiome
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCSORC004913
Identifier Type: OTHER
Identifier Source: secondary_id
CCSORC004913
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.