A Twelve Week Study of Supervised Mouth Rinse and Flossing
Status and phase
Completed
Phase 4
Conditions
Healthy
Treatments
Other: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)
Other: 5% Hydroalcohol Mouth Rinse
Other: American Dental Association (ADA) Referenced Toothbrush
Other: Colgate Cavity Protection Toothpaste
Other: REACH Dental Floss
Details and patient eligibility
About
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.
Enrollment
149 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
149 participants in 4 patient groups
Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)
Experimental group
Description:
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.
Treatment:
Other: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)
Other: Colgate Cavity Protection Toothpaste
Other: American Dental Association (ADA) Referenced Toothbrush
Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)
Experimental group
Description:
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.
Treatment:
Other: Colgate Cavity Protection Toothpaste
Other: American Dental Association (ADA) Referenced Toothbrush
Other: 5% Hydroalcohol Mouth Rinse
Group 3: Flossing Performed by Dental Hygienist
Experimental group
Description:
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.
Treatment:
Other: Colgate Cavity Protection Toothpaste
Other: REACH Dental Floss
Other: American Dental Association (ADA) Referenced Toothbrush
Group 4: Flossing under Supervision
Experimental group
Description:
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.
Treatment:
Other: Colgate Cavity Protection Toothpaste
Other: REACH Dental Floss
Other: American Dental Association (ADA) Referenced Toothbrush
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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