Objectives: To compare the effect of the Philips Sonicare DiamondClean plus Premium plaque control brush head with the Oral-B 7000 plus CrossAction brush head on gingivitis and supragingival plaque reduction following a 42-day period of home use.
Methods: This was a randomized, parallel, examiner-blind, prospective clinical trial conducted on generally healthy subjects. Eligible subjects met the following eligibility criteria: age 18-65, non-smoker, routine manual toothbrush user, ≥ 50 sites of gingival bleeding per the Gingival Bleeding Index (GBI), and ≥ 1.8 plaque score per the Modified Plaque Index (MPI), assessed three to six hours following the last oral hygiene procedure. Eligible subjects were enrolled in the study and randomly assigned to use either a Philips Sonicare DiamondClean with Premium plaque control brush head power toothbrush (SPC) or an Oral-B® 7000 with CrossAction™ brush head power toothbrush (OCA), for twice daily home use over a period of 42 days. All subjects were dispensed a standard fluoride-containing dentifrice and both toothbrushes were to be used in their respective Deep Clean modes. Safety and efficacy evaluations were performed at 14 and 42 days following Baseline.
Results: Two-hundred eighty-four subjects completed this trial (142 subjects per treatment group). Least squares mean (95% CI) estimates for reduction and percent reduction of gingivitis per Modified Gingival Index (MGI) following 42 days of product use for the SPC group were 1.17 (1.10, 1.24) and 45.68% (42.95%, 48.40%); for the OCA group they were 0.69 (0.62, 0.76) and 26.83% (24.10%, 29.56%). The mean difference (95% CI) between the two treatment groups was 0.48 (0.38, 0.58) and 18.85% (14.99%, 22.70%) for reduction and percent reduction, respectively. The lower limit of the 95% CI for the difference in Overall score between the two treatment groups was greater than the predefined non-inferiority margin (i.e., -0.10 or -5%); therefore SPC was declared non-inferior to OCA. In addition, since the 95% CI for the difference did not include zero, SPC was declared superior to OCA in the reduction of gingivitis per MGI at Day 42 (p-value < 0.0001). Similarly, for MGI at Day 14 and for GBI and MPI at Day 14 and Day 42, significantly larger reductions were observed for SPC compared to OCA (p-value < 0.0001).
Conclusions: Philips Sonicare DiamondClean with Premium plaque control brush head (SPC) was statistically superior to the Oral-B 7000 with CrossAction brush head (OCA) in reducing gingival inflammation, gingival bleeding, and supragingival plaque following 14 and 42 days of home use. Both products were safe for use.
Keywords: Oral-B; Sonicare; clinical trials; gingivitis; oscillating-rotating; plaque; powered toothbrushes; sonic.