A Study of Virtually Supervised Mouth Rinses and Flossing

NCT05600231 | Completed Phase 4

• 1 other identifier: CCSORC004913
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  After 12 weeks

Secondary Outcomes (17)

• Marginal Mean TPI After 4 and 12 Weeks

  After 4 and 12 weeks

• Marginal Mean MGI After 4 and 12 Weeks

  After 4 and 12 weeks

• Marginal Mean Expanded Bleeding Index (EBI) After 4 and 12 Weeks

  After 4 and 12 weeks

• Interproximal Mean TPI After 4 Weeks

  After 4 weeks

• Interproximal Mean MGI After 4 Weeks

  4 weeks

Study Arms (6)

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.

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.

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.

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.

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.

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.

Interventions

LISTERINE COOL MINT Antiseptic Mouthwash OTHER

Participants will use LISTERINE COOL MINT Antiseptic Mouthwash for 30 second after brushing teeth twice daily.

Treatment Group: Brush / Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)

LISTERINE COOL MINT ZERO Alcohol Mouthwash OTHER

Participants will use LISTERINE COOL MINT ZERO Alcohol Mouthwash for 30 second after brushing teeth twice daily.

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 Floss OTHER

Participants after brushing for 1 timed minute, will rinse mouth with water and Floss once a day.

Treatment Group: Brush / Floss; Treatment Group: Brush / Floss / Rinse (LISTERINE COOL MINT ZERO Alcohol Mouthwash)

Colgate Cavity Protection Toothpaste OTHER

Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (12)

• 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.

  PMID: 12699051 BACKGROUND

• 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.

  PMID: 15127875 BACKGROUND

• 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.

  PMID: 12691269 BACKGROUND

• Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.

  BACKGROUND

• 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.

  PMID: 2709366 BACKGROUND

• 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.

  PMID: 7806674 BACKGROUND

• 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.

  PMID: 2524573 BACKGROUND

• 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.

  PMID: 13809868 BACKGROUND

• 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.

  PMID: 3485495 BACKGROUND

• 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.

  PMID: 5264376 BACKGROUND

• 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.

  PMID: 38760758 DERIVED

• 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.

  PMID: 38310236 DERIVED

Related Links

• Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque, Gingivitis, and Microbiome

MeSH Terms

Interventions

Ethanol; Mouthwashes

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jeffery Milleman, DDS

  Salus Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: April 18, 2022
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)