A clinical comparison of the gingivitis reduction and plaque-removal efficacy of a new manual toothbrush.

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 (Colgate 360 degrees toothbrush) to the Oral-B CrossAction toothbrush for the control of supragingival plaque and gingivitis. A total of 80 subjects from the central 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 18 to 67 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 of use, subjects returned to the clinical facility for a final gingivitis and plaque examination. Seventy-eight 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 group using the new manual toothbrush exhibited a statistically significant greater reduction in plaque of up to 40% and no statistically significant difference in gingivitis reduction after 4 weeks of use, as compared to the Oral-B CrossAction toothbrush.

RCT Entities:   Population Interventions Outcomes