A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing

Completed · Phase 4

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04750005

Run by

Johnson & Johnson Consumer Inc. (J&JCI)

People needed

209

Starts

2020-10-23

Expected to finish

2021-02-01

Last updated by the study team

2022-02-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Salus Research, Inc. — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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