The objective of this controlled, examiner blind, 4-week clinical study was to evaluate and compare the safety and efficacy of a newly designed manual toothbrush, the Colgate 360 degrees toothbrush, to the Oral-B Indicator toothbrush for the control of supragingival plaque and gingivitis. A total of 82 subjects from the northern New Jersey area reported to the clinical facility for a baseline plaque and gingivitis examination after having refrained from all oral hygiene procedures for 12 hours and from eating, drinking, or smoking for 4 hours. The population was comprised of healthy adult men and women 30 to 68 years of age. After the baseline examinations, qualifying subjects were randomized into two groups and assigned to one of the two test toothbrushes. All subjects were instructed to brush their teeth for 1 minute under supervision, after which they were again examined for supragingival plaque. They were then instructed to brush their teeth twice a day for 1 minute with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection Great Regular Flavor Fluoride Toothpaste) for the next 4 weeks. After 4 weeks, subjects returned to the clinical facility for a final gingivitis and plaque examination. Eighty-one subjects complied with the protocol and completed the 4-week clinical study. The results of the study indicated that the new manual toothbrush was statistically significantly effective in reducing gingivitis after 4 weeks and in removing plaque after a single toothbrushing and after 4 weeks of use. Also, the new manual toothbrush exhibited a statistically significant greater reduction in gingivitis and in gingivitis-related bleeding sites after 4 weeks of use as well as statistically significant greater plaque removal after a single toothbrushing and after 4 weeks of use, as compared to the Oral B Indicator toothbrush. This superior plaque-removal performance was found in separate analyses of the whole mouth, at interproximal surfaces, and at the gumline.