A Twelve Week Study of Supervised Mouth Rinse and Flossing

Completed · Phase 4

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04696536

Run by

Johnson & Johnson Consumer Inc. (J&JCI)

People needed

149

Starts

2018-09-26

Expected to finish

2018-12-21

Last updated by the study team

2021-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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