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A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04750005
Recruitment Status : Completed
First Posted : February 11, 2021
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with an alcohol containing essential oil mouth rinse; brushing and flossing; versus brushing and rinsing with an alcohol containing essential oil mouth rinse; and brushing only for the prevention and reduction of plaque and gingivitis.

Condition or disease Intervention/treatment Phase
Healthy Other: Listerine Cool Mint Other: Colgate Cavity Protection Toothpaste Other: Reach Unflavored Waxed Dental Floss Other: American Dental Association (ADA) Ref Toothbrush Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis
Actual Study Start Date : October 23, 2020
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Listerine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Brush only Group
Participants assigned to this group will brush their teeth using soft bristled toothbrush and colgate cavity protection toothpaste as directed under virtual supervision once daily during the week. Participants will brush second time unsupervised daily in the evening and twice daily over the weekend/holidays at home.
 Other: Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Other: American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Experimental: Brush/Rinse Group
Participants assigned to this group will perform their regimen (brushing [soft bristled toothbrush and colgate cavity protection toothpaste] and rinsing [listerine cool mint antiseptic mouthwash]) as directed under virtual supervision once daily during the week. Participants will brush and rinse a second time unsupervised daily in the evening at home. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over the weekend/holidays. First product use will occur at the site under supervision.
 Other: Listerine Cool Mint
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.

Other: Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Other: American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Experimental: Brush/Floss Group
Participants assigned to this group will perform their regimen (brushing and flossing) as directed under virtual supervision once daily during the week. At home, participants will brush a second time unsupervised daily in the evening. Over the weekend and holidays, participants will brush and floss once daily. Only brushing will be performed a second time in the evening. First product use will occur at the site under supervision.
 Other: Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Other: Reach Unflavored Waxed Dental Floss
Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.

Other: American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Experimental: Brush/Floss/Rinse Group
Participants assigned to this group will perform their regimen (brushing [soft bristled toothbrush and colgate cavity protection toothpaste], flossing [reach unflavored waxed dental floss] and rinsing [listerine cool mint antiseptic mouthwash]) as directed under virtual supervision once daily during the week. Participants will brush and rinse a second time unsupervised daily in the evening. Over the weekend and holidays, participants will brush, floss and rinse once daily. Only brushing and rinsing will be performed a second time in the evening at home.
 Other: Listerine Cool Mint
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.

Other: Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Other: Reach Unflavored Waxed Dental Floss
Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.

Other: American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.


Outcome Measures
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Primary Outcome Measures :
  1. Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use [ Time Frame: 12 Weeks ]
    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).

  2. Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use [ Time Frame: 12 Weeks ]
    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).


Secondary Outcome Measures :
  1. Marginal and Interproximal Mean Turesky Plaque Index (TPI) Score After 4 and 12 Weeks of Product use [ Time Frame: 4 Weeks and 12 Weeks ]
    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).

  2. Marginal and Interproximal Mean Modified Gingival Index (MGI) Score After 4 and 12 Weeks of Product use [ Time Frame: 4 Weeks and 12 Weeks ]
    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).

  3. Marginal Mean Expanded Bleeding Index (EBI) Score After 4 and 12 Weeks of Product use [ Time Frame: 4 Weeks and 12 Weeks ]
    Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 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).

  4. Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use [ Time Frame: 4 Weeks ]
    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).

  5. Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use [ Time Frame: 4 Weeks ]
    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).

  6. Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use [ Time Frame: 4 Weeks and 12 Weeks ]
    Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 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).

  7. Whole-mouth and Interproximal Percent Bleeding Sites, Based on the EBI Score After 4 and 12 Weeks of Product use [ Time Frame: 4 Weeks and 12 Weeks ]
    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 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).

  8. Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks [ Time Frame: 4 Weeks and 12 Weeks ]

    Interproximal Plaque area will be assessed using the PMI on the facial and lingual surfaces. Distal proximal and mesial proximal will be assessed on all teeth including the distal of the second molar using the following scoring system: 0 = No plaque;

    1 = Separate flecks of plaque covering less than 1/3 of the area; 2 = Discrete areas or bands of plaque covering less than 1/3 of the area; 3 = Plaque covering 1/3 of the area; 4 = Plaque covering more than 1/3 but less than 2/3 of the area; 5 = Plaque covering 2/3 or more of the area.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to read and understand (participants capable of reading the documents)
  • Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
  • 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 minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI)
  • Participants will have evidence of some gingivitis; there will be no minimum or maximum mean MGI score for gingivitis or TPI score for plaque; mild to severe gingivitis and mild to moderate periodontitis
  • No more than 3 sites having pocket depths of 5 millimeter (mm) and no sites that are greater than 5 mm in depth

Exclusion Criteria:

  • History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
  • Dental prophylaxis within four weeks prior to Screening/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
  • Suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750005


Locations
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United States, Indiana
Salus Research, Inc.
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
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Principal Investigator: Jeffery Milleman, DDS Salus Research, Inc.
More Information
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Additional Information:

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

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Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT04750005    
Other Study ID Numbers: CCSORC002906
CCSORC002906 ( Other Identifier: Johnson & Johnson Consumer Inc. (J&JCI) )
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: http://yoda.yale.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Listerine
Anti-Infective Agents, Local
Anti-Infective Agents