A Twelve Week Study of Supervised Mouth Rinse and Flossing
NCT ID: NCT04696536
Last Updated: 2021-09-28
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
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COMPLETED
PHASE4
149 participants
INTERVENTIONAL
2018-09-26
2018-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.
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.
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.
Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.
5% Hydroalcohol Mouth Rinse
Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.
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.
Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.
REACH Dental Floss
Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.
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.
Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.
REACH Dental Floss
Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.
Interventions
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Colgate Cavity Protection Toothpaste
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
American Dental Association (ADA) Referenced Toothbrush
Participants will brush teeth at least one minute with provided toothbrush twice daily.
5% Hydroalcohol Mouth Rinse
Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.
REACH Dental Floss
Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffery Milleman, DDS
Role: PRINCIPAL_INVESTIGATOR
Salus Research, Inc.
Locations
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Salus Research, Inc.
Fort Wayne, Indiana, United States
Countries
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References
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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.
Marsh PD. Controlling the oral biofilm with antimicrobials. J Dent. 2010 Jun;38 Suppl 1:S11-5. doi: 10.1016/S0300-5712(10)70005-1.
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.
Related Links
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Other Identifiers
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CCSORC000708
Identifier Type: OTHER
Identifier Source: secondary_id
CCSORC000708
Identifier Type: -
Identifier Source: org_study_id
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