Date of Award
Master of Science (MS)
The purpose of the present 4-week, parallel-arm, single-blinded, clinical study is to investigate the efficacy and safety of a new power toothbrush in comparison with a standard flat trim ADA approved manual brush. The primary objective of this study is to evaluate the efficacy of powered toothbrush on gingivitis reduction compared to a manual toothbrush. Secondary objectives of this study are to evaluate the effectiveness of plaque removal.Materials & Methods: The study was a single-blinded parallel arm randomized controlled interventional trial. Forty-six male and female subjects with gingivitis (32 female and 16 males) with a mean age of 26 years were enrolled but only 44 completed 4-week visit. The subjects were assigned to either of the two different groups (powered brush and manual brush). The test group was assigned to a new power toothbrush while the control group was assigned the ADA approved manual flat trim soft bristle toothbrush for the duration of the 4-week home use trial. Written instructions on brushing and professional brushing demonstration were provided at the outset of the study and repeated at 2- and 4-weeks. Before each visit, subjects had at least 7 hours, but no more than 12 hours of accumulated, non-brushed, undisturbed plaque/debris. Results:The site level reduction was statistically significant in both Manual (Group B) and Powered brush (Group A) for facial sites compared to interproximal sites in percentage BOP (bleeding on probing), MGI (modified gingival index), and PI (plaque index). In group B more reduction in BOP was seen at 2 weeks inter-proximally compared to facial sites whereas the reduction in both facial and interproximal aspects is similar in Group A. At 4 weeks BOP in both groups A and B was significantly reduced in facial sites compared to proximal sites. The patient level analysis showed a trend toward reductions in signs of gingivitis over this short time frame, but did not show any statistically significant reductions in % BOP, MGI, or PI. Conclusion:Both groups demonstrated a reduction in signs of gingivitis (BOP and GI) in this non-flossing population after being repeatedly trained in toothbrush use over a 4-week period. Both tooth brushes were equally effective in reducing overnight plaque as a single use exercise after initial professional training. In the short term, subjects well-trained in the use of either an oscillating-rotating power brush or a manual toothbrush can demonstrate reductions in plaque and gingivitis, but the reductions were not statistically significant.