A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing
Status and phase
Completed
Phase 4
Conditions
Healthy
Treatments
Other: American Dental Association (ADA) Ref Toothbrush
Other: Reach Unflavored Waxed Dental Floss
Other: Colgate Cavity Protection Toothpaste
Other: Listerine Cool Mint
Details and patient eligibility
About
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.
Enrollment
209 patients
Sex
All
Ages
18 to 60 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
209 participants in 4 patient groups
Brush only Group
Active Comparator group
Description:
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.
Treatment:
Other: American Dental Association (ADA) Ref Toothbrush
Other: Colgate Cavity Protection Toothpaste
Brush/Rinse Group
Experimental group
Description:
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.
Treatment:
Other: Listerine Cool Mint
Other: American Dental Association (ADA) Ref Toothbrush
Other: Colgate Cavity Protection Toothpaste
Brush/Floss Group
Experimental group
Description:
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.
Treatment:
Other: Reach Unflavored Waxed Dental Floss
Other: American Dental Association (ADA) Ref Toothbrush
Other: Colgate Cavity Protection Toothpaste
Brush/Floss/Rinse Group
Experimental group
Description:
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.
Treatment:
Other: Reach Unflavored Waxed Dental Floss
Other: Listerine Cool Mint
Other: American Dental Association (ADA) Ref Toothbrush
Other: Colgate Cavity Protection Toothpaste
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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