Research

Goyal, C.R.; Qaqish, J.G.; Galustians, J.; McInnes, C.; BioSci Research Canada, LTD. Mississauga, Ontario; Data on file, 2010

Objectives

To evaluate and compare the plaque removal efficacy and safety of InteliSonic^® DRX-10000 and Sonicare Healthy White 700^® Series power toothbrushes after two minutes of brushing on normal mode for InteliSonic and clean mode for Sonicare Healthy White.

Methodology

Twenty-five subjects were enrolled in a randomized, examiner-blinded, crossover clinical study. To be enrolled into the study, subjects needed a whole mouth plaque level score of >0.60 as determined by the Refined Modified Navy Plaque Index (RMNPI). Subjects refrained from all oral hygiene (including chewing gum) for 23-25 hours prior to all study visits. The two study power toothbrushes included the InteliSonic DRX-10000 and the Sonicare Healthy White 700. InteliSonic was operated in the Normal brushing mode and Sonicare was operated in the Clean brushing mode. All toothbrushes were fully charged and Sonicare’s Easy-start^® feature, which reduces bristle motion, was disabled.

At each study visit, pre-brushing plaque scores (RMNPI) were obtained and an intraoral exam, including both hard and soft tissue, was performed. Following assignment to the randomized treatment, subjects were asked to brush for 2 minutes with their assigned toothbrush and toothpaste according to the respective toothbrush manufacturer’s brushing instructions. A post-brushing plaque assessment (RMNPI) was performed. Product safety in the oral cavity was also assessed. Subjects returned in approximately 48 hours for the crossover visit. Subjects also completed a product evaluation and questionnaire at each visit. Plaque score data was analyzed for whole mouth, interproximal, and gumline plaque removal for each study toothbrush. The significance of the mean change in the plaque score was made within treatment groups using paired t-tests. To evaluate comparisons between treatments, repeated measures analysis of variance (ANOVA) was used for the plaque change scores.

Results

Both toothbrushes showed statistically significant plaque reduction (whole mouth, interproximal and gumline) from pre-brushing (p<0.001). InteliSonic removed significantly more whole mouth plaque than Sonicare with a 78.9% plaque reduction for InteliSonic compared to 75.0% for Sonicare (p=0.042). InteliSonic also removed significantly more gumline plaque, 73.9% for InteliSonic compared to 68.3% for Sonicare (p=0.024). Interproximal plaque reduction for InteliSonic removed was 84.8% versus 83.2% for Sonicare, with this difference not being statistically significant (p=0.356). Both toothbrushes were safe to use; no adverse events were reported. Based on responses to the questionnaire, both toothbrushes were well accepted and received positive evaluations in the areas of cleaning, gentleness, and comfort. Positive comments on InteliSonic included an overall feeling of clean and gentle bristles.

Conclusions

1. InteliSonic was effective in removing plaque from whole mouth, gumline and interproximal surfaces.
2. InteliSonic was superior to Sonicare for whole mouth and gumline plaque removal.
3. InteliSonic and Sonicare achieved comparable interproximal plaque removal.
4. Both brushes were found safe for everyday use.
5. No adverse events reported.
6. Subjects using InteliSonic expressed an immediate sense of clean after brushing.

Kleber, C.J.; Milleman, K.R.; McInnes C. University Park Research Center, Fort Wayne, In and DentistRx, Redmond, WA

Objectives

To evaluate and compare the plaque removal efficacy and safety of Revolation^™ DRX-9000 and a manual toothbrush during typical use.

Methodology

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.

Results

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.

Conclusions

The results of this clinical study found:

1. Revolation was significantly more effective than a manual toothbrush in removing dental plaque.
2. Revolation was particularly more effective at removing hard-to-reach plaque in the Reduction in Plaque (MQHPI) interproximal and lingual areas.
3. Both brushes were found to be safe on gums, teeth, and restorations.
4. No adverse events were reported.
5. Subjects reported that Revolation produced a gentle cleaning action.