A Randomized, Parallel Design Study to Evaluate the Effects of Different Oral Cleaning Modalities on Gingivitis and Plaque After a 6-Week Period of Home Use.

The study objective was to evaluate the effect of different interdental oral cleaning modalities on gingivitis and plaque following a 6-week period of home use. This was a randomized, parallel, examiner-blinded study. Study subjects were routine manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years. Subjects were required to have a gingival bleeding score of ≥1 on at least 50 gingival sites per the Gingival Bleeding Index (GBI) and to have a minimum average plaque score of ≥0.6 per the Rustogi Modified Navy Plaque Index (RMNPI) following a 3- to 6-hour plaque accumulation period. Subjects were randomly assigned to one of four groups based on the oral care cleaning modality: (1) NON group: MTB alone, (2) FLS group: MTB plus string floss, (3) MPF group: MTB plus a Philips® Sonicare® Power Flosser with the Quad Stream nozzle, or (4) PPF group: Philips Sonicare power toothbrush plus the power flosser. Safety and efficacy measures (Modified Gingival Index [MGI], GBI, and RMNPI) were assessed at baseline, 2 weeks, and 6 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 6 as measured by the MGI. A total of 260 subjects were randomized and 256 subjects completed the study. The adjusted mean percent reduction in gingival inflammation from baseline to week 6 was 14.90% for the NON group, 13.16% for the FLS group, 33.51% for the MPF group, and 49.30% for the PPF group. Pairwise comparisons indicated that both the PPF and MPF groups were statistically significantly different from both the NON and FLS groups. In conclusion, use of either the Philips Sonicare power toothbrush with the Philips Sonicare Power Flosser or an MTB with the Philips Sonicare Power Flosser was statistically superior to an MTB alone and an MTB used with string floss in reducing gingival inflammation following 6 weeks of home use.

A Randomized, Parallel Design Study to Compare the Effects of Two Different Interdental Cleaning Modalities on Gingivitis and Plaque After a 4-Week Period of Home Use.

The study objective was to evaluate the effect of two different interdental oral cleaning modalities on gingivitis and plaque following a 4-week period of home use. This was a randomized, parallel, single-blinded study. Subjects were routine manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years. Subjects were required at baseline to have a gingival bleeding score of ≥1 on at least 50 gingival sites per the Gingival Bleeding Index (GBI) and to have an overall plaque score of ≥0.6 per the Rustogi Modified Navy Plaque Index (RMNPI) following a 3- to 6-hour plaque accumulation period. Subjects were randomly assigned to one of three groups based on the oral care cleaning modalities: (1) NON group: MTB alone, (2) IDB group: MTB plus an interdental brush, or (3) MPF group: MTB plus a Philips® Sonicare® Power Flosser with the Quad Stream nozzle. All subjects used the MTB with fluoride toothpaste. Efficacy measures (Modified Gingival Index [MGI], GBI, and RMNPI) and safety were assessed at baseline, 2 weeks, and 4 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 4 as measured by the MGI. A total of 189 subjects were randomized and 186 completed the study. The adjusted mean percent reduction in gingival inflammation from baseline to week 4 was 2.80% for the NON group, 11.32% for the IDB group, and 20.87% for the MPF group. The differences between the MPF group and the NON and IDB groups were statistically significant (.0001). In conclusion, use of the MTB with the Philips Sonicare Power Flosser showed statistically significant benefits compared to an MTB alone and an MTB used with an interdental brush in reducing gingival inflammation following 4 weeks of home use.

A Randomized, Parallel Design Study to Compare the Effects of Different Interdental Cleaning Modalities on Gingivitis and Plaque After a 6-Week Period of Home Use.

The objective of this study was to evaluate the effect of different interdental oral cleaning modalities on gingivitis and plaque following a 6-week period of home use. This was a randomized, four-arm, parallel design clinical trial. Study subjects were manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years. Subjects were required at baseline to have a gingival bleeding score of ≥1 on at least 50 gingival sites per the Gingival Bleeding Index (GBI) and to have an overall plaque score of ≥0.6 per the Rustogi Modified Navy Plaque Index (RMNPI) following a 3- to 6-hour plaque accumulation period. Subjects were randomly assigned to use one of four oral care cleaning modalities: (1) NON group: MTB alone, (2) FLS group: MTB plus string floss, (3) IDB group: MTB plus an interdental brush, or (4) CPF group: MTB plus the Philips® Sonicare® Cordless Power Flosser with the Quad Stream nozzle. Efficacy measures (Modified Gingival Index [MGI], GBI, and RMNPI) and safety were assessed at baseline, 2 weeks, and 6 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 6 as measured by the MGI. Of the 372 subjects randomized in the study, 364 completed a post-baseline MGI evaluation and were included in the analyses. The adjusted mean percent reduction in gingival inflammation from baseline to week 6 was -2.10% for the NON group, 2.82% for the FLS group, 2.60% for the IDB group, and 29.10% for the CPF group. Pairwise comparisons indicated that the CPF group was statistically significantly different from the NON, FLS, and IDB groups (.0001). In conclusion, adjunctive use of the Philips Sonicare Cordless Power Flosser with the Quad Stream nozzle and an MTB showed statistically better results in term of reducing gingival inflammation following 6 weeks of home use when compared to an MTB alone, an MTB used with string floss, and an MTB used with an interdental brush.

In Vitro Comparison of the Area of Biofilm Removal by the Quad Stream Nozzle Versus a Traditional Oral Irrigator Standard Nozzle.

The objective of this in vitro study was to compare the area of oral biofilm removal by the Philips Sonicare Quad Stream (PSQS) nozzle (used on a Philips® Sonicare® Power Flosser) and a traditional oral irrigator with a standard nozzle (TOIS) when used per the directions for use (DFU) instructions for both devices.

A Comparison of the Effect of Two Power Toothbrushes on the Reduction of Gingival Inflammation and Supragingival Plaque.

OBJECTIVES: To compare the effect of the Philips Sonicare DiamondClean Smart and Oral-B Genius 8000 powered toothbrushes on gingivitis, gingival bleeding, and supragingival plaque reduction following 42 days of home use. METHODS: This was a randomized, parallel, examiner-blinded, prospective clinical trial with two treatment groups. Eligible participants were generally healthy volunteers who were manual toothbrush users, non-flossers, 18-65 years of age. The subject panel included non-smokers with = 50 sites of gingival bleeding according to the Gingival Bleeding Index (GBI), and a supragingival plaque score of = 1.8 per Modified Plaque Index (MPI) at 3-6 hours following last tooth brushing encounter. Eligible subjects were randomized to use either a Philips Sonicare DiamondClean Smart with Premium Plaque Control brush head (DCS) or an Oral-B Genius 8000 with FlossAction brush head (OBG) for home use. Each toothbrush was used twice daily for two minutes. All subjects used a standardized fluoride-containing dentifrice. All other oral hygiene measures were prohibited. Subjects returned at Day 14 for an interim compliance and safety assessment, and at Day 42 for the final safety and efficacy assessments. RESULTS: Of 222 enrolled and eligible subjects, 219 completed (112 in the SDC group, 107 in the OBG group) the study. The least squares (LS) mean and 95% confidence interval (CI) estimates for gingivitis reduction and percent reduction per Modified Gingival Index (MGI) following 42 days of product home use were 1.38 (1.30, 1.46) and 51.32% (48.45%, 54.19%) for DCS, and 0.53 (0.45, 0.61) and 20.07% (17.14%, 23.00%) for OBG. The differences, expressed as either reduction or percent reduction, were statistically significant between the two groups, p < 0.001. Statistically significant differences were also observed between products at Day 42 for the gingival bleeding and supragingival plaque reduction endpoints, p < 0.001. There were two reported adverse events. CONCLUSIONS: The Philips Sonicare DiamondClean Smart powered toothbrush reduced gingival inflammation, gingival bleeding, and supragingival plaque significantly more than the Oral-B Genius 8000 powered toothbrush following a 42-day home-use period. Both products were safe for use.

A Randomized Parallel Study to Assess the Effect of Three Tongue Cleaning Modalities on Oral Malodor.

OBJECTIVES: The objective of this study was to compare the effects of three tongue hygiene regimens on oral malodor. METHODS: This was a single-center, randomized, parallel design study with three treatment groups. Subjects were randomly assigned to perform tongue hygiene with either the Philips Sonicare TongueCare+ BreathRx regimen (STC), Listerine Cool Mint antiseptic rinse (LCM), or tongue brushing with an ADA reference manual toothbrush (MTB). Tooth brushing was standardized for all subjects during the study period, and no other oral or breath hygiene measures were allowed. Eligible subjects met the following criteria: aged 18-70 years, in good general and oral health, non-smoker, with an organoleptic score between 2.7 and 4.5 following a 12-18 hour oral hygiene abstention period. Subjects who had oral appliances or who had periodontal disease or excessive recession were not eligible. The primary endpoint analysis was to evaluate oral malodor based on an organoleptic (OL) score. Additional surrogate measures for oral malodor included quantification of oral hydrogen sulfide (H2S) level and counts of oral bacteria in secondary analyses. At Day 1, all three malodor endpoints were assessed prior to product use, immediately after use, and four and eight hours after use. Subjects were then provided with instructions on product use at home. Subjects returned to the clinic on Day 8 and the assessments for malodor were repeated for each of the three endpoints, i.e., prior to in-clinic use of the products, immediately after use, and four and eight hours after use. RESULTS: One hundred sixty-eight (168) subjects were randomized to three groups, with 56 per treatment group. Of these, 165 completed all study visits. Randomized subjects were comparable for baseline characteristics (OL score, age, race, and ethnicity). Overall, oral malodor based on the organoleptic score decreased for all treatment groups at all timepoints. For the primary endpoint, reduction of OL score eight hours following a single product use, the STC regimen reduced malodor per OL score by 46.67% (SE = 2.28%), the LCM value was 22.83% (SE = 2.29%), and MTB was 26.19% (SE = 2.29%). The pair-wise comparisons between STC and each of the treatment groups were statistically significant (p-values < 0.0001). Statistically significant differences were also observed between STC and both LCM and MTB groups in pair-wise comparisons at Day 8 (p-values < 0.0001). CONCLUSIONS: Reductions in malodor were evident following a single use of each product, and also following a seven-day repeat use period. The STC regimen, however, was statistically significantly superior to both LCM and MTB at improving malodor eight hours following the first use. Statistically significant differences in OL scores were sustained between STC and LCM, and STC and MTB at each efficacy timepoint following the seven-day home use period.