A company earns the ADA Seal for its product by providing evidence that meets the ADA criteria for safety and efficacy. The ADA Council on Scientific Affairs carefully evaluates the evidence according to the Guidelines for Participation in the ADA's Seal of Acceptance Program
. In addition, there is a specific guideline for this product category called Dental Floss or Other Interdental Cleaners
which includes, but is not limited to, the following criteria:
- Evidence must be provided that the components of the product are safe for use in the oral cavity
In accordance with this guideline, they included the following studies:
In this study Finkelstein et. al. examined 107 adult subjects in a six-week clinical trial comparing regular brushing with either STIM-U-DENT or J & J’s waxed dental floss. After a two-week period of brushing only, subjects were divided into the following three cells: brushing only, brushing and STIM-U-DENT, and brushing and flossing. Reduction in gingivitis scores were the following: 46% for STIM-U-DENT, 49% for floss, and 14% for brushing only. Reduction in plaque scores was not significant [14%, 18% and 9%, respectively].
In this study  by Finkelstein et.al examined 77 adult subjects with the same timeframe as above. This was a two cell consisting of regular brushing with and without STIM-U-Dent and the outcome measure was interdental bleeding scale. Reduction in gingival bleeding scores were 52% for brushing and STIM-U-DENT versus 9% for brushing alone. Plaque scores or any other clinical measures were not recorded.
In this 1987 study, Finkelstein et.al obtained gingival papillary biopsies from 30 subjects and found a statistical correlation between an increased inflammatory cell infiltrate in gingival samples and sites where bleeding was elicited upon insertion with STIM-U-DENT. Bleeding sites were roughly twice as likely to have inflamed connective tissue upon histological examination when compared to non-bleeding sites.