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A Twelve Week Study of 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: NCT04696536
Recruitment Status : Completed
First Posted : January 6, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Brief Summary:
The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis.

Condition or disease Intervention/treatment Phase
Healthy Other: Colgate Cavity Protection Toothpaste Other: American Dental Association (ADA) Referenced Toothbrush Other: 5% Hydroalcohol Mouth Rinse Other: REACH Dental Floss Other: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis
Actual Study Start Date : September 26, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Listerine

Arm Intervention/treatment
Experimental: Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)
Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
Other: Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.

Other: American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.

Other: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)
Participants after brushing, rinse with 20mL of the AEO mouth rinse for 30 seconds twice a day.

Experimental: Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)
Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
Other: Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.

Other: American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.

Other: 5% Hydroalcohol Mouth Rinse
Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.

Experimental: Group 3: Flossing Performed by Dental Hygienist
Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
Other: Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.

Other: American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.

Other: REACH Dental Floss
Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.

Experimental: Group 4: Flossing under Supervision
Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
Other: Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.

Other: American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.

Other: REACH Dental Floss
Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.




Primary Outcome Measures :
  1. Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use [ Time Frame: 12 Weeks ]
    Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.

  2. Interproximal Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use [ Time Frame: 12 Weeks ]
    Gingivitis will be assessed using 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.


Secondary Outcome Measures :
  1. Interproximal Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use [ Time Frame: 4 Weeks ]
    Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.

  2. Interproximal Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use [ Time Frame: 4 Weeks ]
    Gingivitis will be assessed using 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. Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 12 Weeks of Product use [ Time Frame: 4 Weeks and 12 Weeks ]
    Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.

  4. Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 12 Weeks of Product use [ Time Frame: 4 Weeks and 12 Weeks ]
    Gingivitis will be assessed using 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.

  5. 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 Gingival Bleeding Index. 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 4 gingival areas (distobuccal, mid-buccal, 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.

  6. Whole-mouth and Interproximal Percent Bleeding Sites, Based on the BI Score After 4 and 12 Weeks of Product use [ Time Frame: 4 Weeks and 12 Weeks ]
    Bleeding will be assessed according to the Gingival Bleeding Index. 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 4 gingival areas (distobuccal, mid-buccal, 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. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products according to instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
  • Able to attend once daily session during weekdays for flossing and rinsing occurring on site
  • Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
  • Able to read and understand the local language (participants capable of reading the documents)
  • Adequate oral hygiene (that is brush teeth daily and exhibit no signs or oral neglect)
  • 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 bleeding sites based on the BI
  • Absence of advanced periodontitis based on a clinical examination at Baseline and discretion of the dental examiner

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
  • Dental prophylaxis within four weeks prior to Screening/Baseline visit
  • History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
  • Antibiotic, 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 within the two weeks prior to Baseline

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): NCT04696536


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.
Additional Information:
Publications:
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Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT04696536    
Other Study ID Numbers: CCSORC000708
CCSORC000708 ( Other Identifier: Johnson & Johnson Consumer Inc. (J&JCI) )
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: April 2021
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