OBJECTIVE To evaluate the safety and efficacy of a new manual toothbrush by comparing plaque removal and gingivitis reduction after 4 weeks of use. METHODS This monadic clinical study included 46 subjects from the Northern New Jersey area who reported to the clinical facility for a baseline plaque and gingivitis examination after having refrained from all oral hygiene procedures and chewing gum for 8 hours, and from eating, drinking, or smoking for 4 hours. The population was comprised of healthy adult male and female subjects aged 27-68 years. Subjects were instructed to brush their teeth for 1 minute, twice a day with their assigned toothbrush and a commercially-available fluoride toothpaste (Colgate Cavity Protection Great Regular Flavor). After 4 weeks of use, subjects returned to the clinical facility for a final gingivitis and plaque examination. RESULTS All 46 subjects complied with the protocol and completed the 4-week clinical study. The results of the study indicated that the new manual toothbrush was significantly effective in reducing gingivitis and removing plaque after 4 weeks of use. Specifically, the results indicated a 17-39% reduction in gingival sites. In addition, the results indicated plaque removal of up to 96.5% in some parts of the mouth.