In vivo study
Kleber, C.J.; Milleman, K.R.; McInnes C. University Park Research Center, Fort Wayne, In and DentistRx, Redmond, WA
To evaluate and compare the plaque removal efficacy and safety of Revolation™ DRX-9000 and a manual toothbrush during typical use.
Twenty five subjects were enrolled in a randomized, examiner-blind, crossover clinical study. To be enrolled in the study, subjects needed a full-mouth plaque score of = 2.00 as determined by the Modified Quigley-Hein Plaque Index (MQHPI). Subjects refrained from all oral hygiene for 24±2 hours prior to all study visits. The study consisted of one clinic visit for each test product. the two test products were the Revolation™ power toothbrush (Dentistrx®, Redmond, WA) and a manual toothbrush (Oral-B® Indicator®, Soft 35 Compact, Procter & Gamble, Cincinnati, OH). Subjects brushed for two minutes with the Revolation as recommended by the user’s manual. To provide a typical Revolation tooth brushing experience, subjects brushed the complete dentition for 1 minute with the everyday brush head and subsequently for 1 minute with the perio brush head. To provide a typical manual toothbrush brushing experience, subjects brushed the complete dentition for 1 minute. All subjects were given verbal cues every 15 seconds to move to the next quadrant, thereby equalizing brushing throughout the mouth.
At each study visit pre-brushing plaque scores (MQHPI) were recorded along with data from an intraoral exam of soft and hard tissue. Subjects were then randomly assigned to treatment and given written and oral brushing instructions according to their assignment. Subjects brushed in the presence of an assistant who provided verbal cues when to move between quadrants of the oral cavity. A post-brushing assessment of plaque removal and tissue was performed as was done prior to brushing. At the end of the visit, subjects completed a written questionnaire. Subjects returned approximately 48 hours for the crossover visit wherein the alternate treatment was assigned. Plaque score data was analyzed for the whole mouth as well as for interproximal, marginal (gumline), facial, and lingual regions. The significance of the mean change in the plaque score was made within treatments using paired t-tests. To evaluate comparisons between treatments, repeated measures analysis of variance (anova) was used for the plaque change scores.
Analysis of the pre-brushing plaque scores indicate that both groups (Revolation and manual) were balanced at baseline. Both toothbrushes showed statistically significant reductions in plaque after brushing (p<0.0001) for the full mouth plaque scores as well as scores for the various regions of the oral cavity. The Revolation toothbrush was significantly more effective than the manual toothbrush in removing plaque for all the various tooth surfaces (p<0.0001). The results indicate that both brushes performed the best on easier to reach plaque along the gumline and on the facial surfaces. The difference in mqhp scores between Revolation and a manual toothbrush, expressed on a percentage basis, was greatest in the interproximal and lingual regions. The Revolation was particularly more effective in removing plaque in these hard-to-reach areas. Both toothbrushes were found safe to use, and no adverse events were reported. Based on responses to the questionnaire, subjects felt both brushes were effective in removing plaque, but that Revolation provided a more gentle cleaning experience.
The results of this clinical study found:
Oral-B® and Indicator® are registered trademarks of the Procter & Gamble Company
- Revolation was significantly more effective than a manual toothbrush in removing dental plaque.
- Revolation was particularly more effective at removing hard-to-reach plaque in the Reduction in Plaque (MQHPI) interproximal and lingual areas.
- Both brushes were found to be safe on gums, teeth, and restorations.
- No adverse events were reported.
- Subjects reported that Revolation produced a gentle cleaning action.