Status:
COMPLETED
A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing
Lead Sponsor:
Johnson & Johnson Consumer Inc. (J&JCI)
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT04750005
Start Date
October 23 2020
End Date
February 1 2021
Last Update
February 16 2022
Active Locations (1)
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1
Salus Research, Inc.
Fort Wayne, Indiana, United States, 46825