Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse

A Visual Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse in Orthodontic Subjects

This study aims to investigate the impact of a bromelain pre-rinse adjunct on oral plaque removal in orthodontic subjects. The study's null hypothesis states that there is no statistically significant difference in visual plaque scores among orthodontic subjects with or without proteolytic enzyme rinse aid.

Bromelain, a naturally occurring cysteine protease, from pineapple stalks, is used in food and medical industries and listed on the FDA's "Generally Recognized As Safe" (GRAS) list. In vitro bromelain study demonstrated antibacterial effect on oral pathogens. Bromelain was found to prevent biofilm formation by interfering with bacteria-bacteria adhesion and/or adhesion to enamel surface. Clinical trials with toothpaste containing bromelain demonstrated improved plaque and gingivitis scores and extrinsic enamel stain removal capabilities. The impact of bromelain application prior to traditional mechanisms of plaque removal have not been clearly evaluated.

Inclusion Criteria:

• male or female
• 10 to 25 years of age
• willing to consent to participation
• able to follow study instructions
• in active orthodontic treatment with fixed orthodontic appliances

Exclusion Criteria:

• unwilling/unable to follow study instructions
• documented/suspected pineapple allergy
• proteolytic enzyme allergy
• food dye allergy
• smoker