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Completed

NCT Number: NCT04750005

A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Listerine Cool Mint

Other

Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.

Colgate Cavity Protection Toothpaste

Other

Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Reach Unflavored Waxed Dental Floss

Other

Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.

American Dental Association (ADA) Ref Toothbrush

Other

Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2021
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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