Clinical study to evaluate the efficacy of a mouth wash
Research type
Research Study
Full title
Four Week Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis
IRAS ID
140719
Contact name
Robert Maclure
Contact email
Sponsor organisation
Johnson & Johnson Consumer and Personal Products Worldwide
Eudract number
2013-003548-22
Research summary
Gingivitis is a major form of inflammatory disease that affects the structures responsible for supporting the teeth including the gums. The accumulation of bacteria containing dental plaque on the surface of the teeth is the primary cause of this reversible disease. If this plaque accumulation is not controlled tooth loss can occur. Brushing and flossing are considered the gold standard by dental professionals for controlling dental plaque although prevalence of gingivitis is still high. New means of inhibiting, controlling and / or preventing the development of dental plaque are required.
This study evaluates the safety, gum bleeding, inflammation, plaque and stain levels following the use of 3 mouthwashes, when used in conjunction with tooth brushing over four weeks.
This study is being conducted by Johnson & Johnson Consumer and Personal Products Worldwide. Healthy volunteers over the age of 18 with a certain level of gingivitis will be suitable to participate.
Participants will be required to attend the following visits:
Visit 1 – Eligibility will be determined and participants will have baseline levels of gum inflammation, bleeding, stain and plaque assessed. Eligible participants will undergo a scale and polish, supervised first use of product.
Visit 2 - An oral soft tissue examination will be performed followed by gum inflammation and bleeding assessments followed by a plaque assessment.
Visit 3 - An oral soft tissue examination will be performed followed by gum inflammation and bleeding assessments, and stain and plaque assessments. Participants will return their study supplies and will be dispensed with further supplies for the duration of the study.
Visit 4 - An oral soft tissue examination will be performed followed by gum inflammation, bleeding, stain and plaque assessments. Participants will be given the option to have a scale and polish.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0364
Date of REC Opinion
12 Dec 2013
REC opinion
Further Information Favourable Opinion