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.

The effects of scaling and root planing plus home oral hygiene maintenance in Stage I/II periodontitis population: A 24-week randomized clinical trial.

OBJECTIVES: To compare the effects of powered and manual toothbrushing following scaling and root planing on bleeding on probing and other clinical indicators of periodontitis. MATERIALS AND METHODS: This was a randomized, examiner-blind, parallel-design, 24-week clinical study. Eligible subjects were 18-75 years of age with Stage I or II periodontitis. All subjects received scaling and root planing (SRP) within 28 days of enrollment. Thereafter, subjects were randomized to twice daily at-home use of either a powered toothbrush (PTB) or a manual toothbrush (MTB). Randomization was balanced for gender and periodontitis stage. No other oral hygiene aids were permitted. Subjects were evaluated every 4 weeks for the following measures: bleeding on probing (BOP), surface plaque (MPI), probing pocket depth (PPD) and clinical attachment level until Week 24. RESULTS: Of 328 randomized subjects, 299 subjects completed the study. For BOP at Week 24, the Least Squares (LS) Mean, standard error (SE) reduction from baseline was 0.24 (0.01) for the PTB group and 0.02 (0.01) for the MTB group, resulting in a statistically significant treatment difference of 0.22 (0.01), p-value < 0.0001. There were also concomitant reductions in MPI and PPD at Week 24, resulting in statistically significant (p-value < 0.0001) LS Mean (SE) treatment differences of 0.86 (0.04) and 0.24 (0.01), for MPI and PPD, respectively. CONCLUSION: When combined with SRP, daily home oral hygiene maintenance including a powered toothbrush significantly reduced clinical symptoms of periodontitis and surface plaque levels compared to a manual toothbrush in a Stage I/II periodontitis population. (ClinicalTrials.gov Identifier: NCT04254770).

Correction to: Use of an oxygen planar optode to assess the effect of high velocity microsprays on oxygen penetration in a human dental biofilms in-vitro.

An amendment to this paper has been published and can be accessed via the original article.

Use of an oxygen planar optode to assess the effect of high velocity microsprays on oxygen penetration in a human dental biofilms in-vitro.

BACKGROUND: Dental plaque biofilms are the causative agents of caries, gingivitis and periodontitis. Both mechanical and chemical strategies are used in routine oral hygiene strategies to reduce plaque build-up. If allowed to mature biofilms can create anoxic microenvironments leading to communities which harbor pathogenic Gram-negative anaerobes. When subjected to high velocity fluid jets and sprays biofilms can be fluidized which disrupts the biofilm structure and allows the more efficient delivery of antimicrobial agents. METHODS: To investigate how such jets may disrupt anoxic niches in the biofilm, we used planar optodes to measure the dissolved oxygen (DO) concentration at the base of in-vitro biofilms grown from human saliva and dental plaque. These biofilms were subject to "shooting" treatments with a commercial high velocity microspray (HVM) device. RESULTS: HVM treatment resulted in removal of much of the biofilm and a concurrent rapid shift from anoxic to oxic conditions at the base of the surrounding biofilm. We also assessed the impact of HVM treatment on the microbial community by tracking 7 target species by qPCR. There was a general reduction in copy numbers of the universal 16S RNA by approximately 95%, and changes of individual species in the target region ranged from approximately 1 to 4 log reductions. CONCLUSION: We concluded that high velocity microsprays removed a sufficient amount of biofilm to disrupt the anoxic region at the biofilm-surface interface.

The Effects of Use of a Powered and a Manual Home Oral Hygiene Regimen on Plaque and Gum Health in an Orthodontic Population.

OBJECTIVES: The objective of this study was to compare the effect of two home use oral hygiene regimens on plaque, gingivitis, and gingival bleeding on subjects undergoing orthodontic treatment with fixed appliances. METHODS: This was a randomized, parallel, single-center clinical trial. Eligible study subjects fit the following profile: age 12-65 years; nonsmoker; plaque score of = 2.0 per Bonded Bracket Index (BBI) on dentition with fixed orthodontic hardware; minimum of 10 orthodontic brackets in each arch or on all teeth from first molar to first molar; presenting with mild to moderate gingivitis, defined as a score of = 1 on at least 20 sites per Gingival Bleeding Index (GBI). Subjects with advanced periodontal disease or gingival recession were not eligible. Eligible subjects were randomized to one of two home use oral hygiene regimens: manual toothbrush plus string floss (used with a threading device) for interdental cleaning (MTF regimen); or Philips Sonicare EasyClean power toothbrush with InterCare brush head and AirFloss Pro powered device, used with BreathRx mouthrinse for interdental cleaning (Sonicare Orthodontic Regimen or SOR). All subjects brushed twice daily with standard fluoridated dentifrice and performed interdental cleaning once daily. Efficacy and safety examinations were performed at Baseline and following three and six weeks of home use of the study products, and included assessments of BBI, GBI, Modified Gingival Index (MGI), and Modified Plaque Index (MPI). RESULTS: Of 228 enrolled subjects, 223 were included in the primary analysis. For the primary endpoint, reduction in BBI score following three weeks of product use, the overall least squares (LS) mean (95% CI) reduction was 0.89 (0.84, 0.95) for SOR and 0.06 (0.01, 0.12) for MTF. Expressed as percent reduction (95% CI) from Baseline, this was 33.1% (31.1%, 35.2%) for SOR and 2.01% (-0.06%, 4.07%) for MTF. The differences between regimens were statistically significant, p < 0.0001. Statistically significant differences between regimens were observed in BBI following six weeks of product use, and also for all other efficacy variables (GBI, MGI, MPI) at Week 3 and Week 6. CONCLUSIONS: The powered oral hygiene regimen was significantly more effective than a manual regimen in reducing plaque on bracketed and non-bracketed teeth, and in reducing gingival bleeding and gingival inflammation in orthodontic subjects following three weeks of use and persisting following six weeks of use. All products were safe on oral tissues and fixed orthodontic appliances.

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 Compare the Effects of Powered and Manual Tooth Brushing on Gingival Health and Plaque.

OBJECTIVES: To compare the effect of powered and manual tooth brushing on plaque and gingivitis following two and six weeks of home use. METHODS: This was a randomized, three-arm, parallel-design clinical trial. Eligible participants were manual toothbrush users who were generally healthy non-smokers, aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI), and mild to moderate gingivitis, defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, excessive gingival recession, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed one of three devices: a powered toothbrush (Philips Sonicare DiamondClean Smart with Premium Gum Care brush head) used in either Gum Heath mode (DC-GH) or Clean mode (DC-C), or an ADA reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and six weeks following twice-daily product home use. RESULTS: For the primary endpoint, reduction in gingivitis per Modified Gingival Index (MGI) at Week 2, 188 subjects completed and were included in the analysis. Expressed as percent reduction from Baseline, the adjusted mean reduction and Standard Error (SE) estimates were 60.31% (1.95%) for DC-GH, 53.08% (1.95%) for DC-C, and 16.59% (1.96%) for MTB. The difference between each power toothbrush group and the manual toothbrush was statistically significant (p < 0.0001). Statistically significant differences were also observed between DC-GH, DC-C, and manual tooth brushing for MGI at Week 6, as well as for MPI and GBI at Weeks 2 and 6. CONCLUSIONS: The powered toothbrush, used in either Gum Health or Clean mode, was statistically significantly superior to a manual tooth brush in reducing gingival inflammation, gingival bleeding, and plaque following two and six weeks of home use.

A Comparison of the Effects of a Powered and Manual Toothbrush on Gingivitis and Plaque: A Randomized Parallel Clinical Trial.

OBJECTIVES: To compare the effect of a powered and a manual toothbrush on gingivitis and plaque following two and four weeks of home use. METHODS: This was a randomized, parallel-design, single-blind clinical trial. Eligible participants were generally healthy non-smoking manual toothbrush users aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI) following a 3-6 hour plaque accumulation period, and mild to moderate gingivitis defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, xerostomia, excessive gingival recession, uncontrolled diabetes, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed either a Philips Sonicare powered toothbrush used with the InterCare brush head (PTB) or an American Dental Association (ADA) reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and four weeks following twice-daily product home use. The primary endpoint of the study was reduction of gingivitis per the Modified Gingival Index (MGI) after four weeks of home use. RESULTS: All 148 randomized subjects (74 per group) completed the study. A statistically significant difference in MGI reduction was observed between the two study groups (p < 0.001). The least square (LS) mean and standard error reduction from Baseline was 0.72 (0.04) for the PTB group compared to 0.09 (0.04) for the MTB group. Expressed as percent reduction from Baseline, the LS mean values were 35.77% (2.19%) and 4.22% (2.19%) for PTB and MTB, respectively. Statistically significant differences were also observed for MGI reduction at Week 2, as well as for MPI and GBI reduction at Weeks 2 and 4. CONCLUSIONS: The powered toothbrush was statistically significantly superior to a manual toothbrush in reducing gingival inflammation, gingival bleeding, and plaque following two and four weeks of home 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.

A 3 months clinical evaluation comparing two professional bleaching systems of 25% and 40% hydrogen peroxide and extended treatment outcome using a power versus a manual toothbrush.

OBJECTIVES: To assess two professional tooth bleaching products: Philips Zoom WhiteSpeed (PZW) and Ultradent Opalescence Boost PF (UOB); and to assess bleaching maintenance after use of Philips Sonicare power toothbrush (SDC) or manual toothbrush (MTB). METHODS: There was a randomized, parallel clinical trial. Eligible subjects were 18-75 years, with VITA Classical shade (VCS) of A3 on anterior teeth. Subjects were randomized to bleaching with PZW or UOB. Tooth color and shade were assessed using VITA EasyShade (VES), VCS, and VITA Bleachedguide (VBG). Subjects returned on Days 7 and 30. On Day 30, participants were dispensed either SDC or MTB for home use until Day 90. RESULTS: A total of 135 subjects completed the study. For the primary endpoint, ΔE at Day 7, a significantly larger reduction was observed for PZW than UOB (P value = .0059). Significant differences in shade were also observed at Day 7 for VCS (P value = 0.0106), and VBG (P value = .0489). On Day 90, the SDC was statistically superior to MTB in maintaining shade per VBG and VCS, but not ΔE. CONCLUSIONS: At Day 7, PZW showed statistically greater change in overall color and shade than UOB. The SDC maintained tooth shade significantly better than MTB. Both bleaching regimens were safe. CLINICAL SIGNIFICANCE: The outcomes confirm the bleaching efficacy advantage of a lower H2 O2 dose-LED accelerated professional tooth bleaching system, compared to a higher-dose H2 O2 approach. The safety assessments via clinical intraoral exam and daily logged use of subjects' desensitizing agents, and the incidence and severity of reported sensitivity, provide evidence that both professional products are safe for use. Finally, powered tooth brushing may confer an advantage to manual tooth brushing in maintaining tooth shade-change results following professional whitening.

Fluid-driven interfacial instabilities and turbulence in bacterial biofilms.

Biofilms are thin layers of bacteria embedded within a slime matrix that live on surfaces. They are ubiquitous in nature and responsible for many medical and dental infections, industrial fouling and are also evident in ancient fossils. A biofilm structure is shaped by growth, detachment and response to mechanical forces acting on them. The main contribution to biofilm versatility in response to physical forces is the matrix that provides a platform for the bacteria to grow. The interaction between biofilm structure and hydrodynamics remains a fundamental question concerning biofilm dynamics. Here, we document the appearance of ripples and wrinkles in biofilms grown from three species of bacteria when subjected to high-velocity fluid flows. Linear stability analysis suggested that the ripples were Kelvin-Helmholtz Instabilities. The analysis also predicted a strong dependence of the instability formation on biofilm viscosity explaining the different surface corrugations observed. Turbulence through Kelvin-Helmholtz instabilities occurring at the interface demonstrated that the biofilm flows like a viscous liquid under high flow velocities applied within milliseconds. Biofilm fluid-like behavior may have important implications for our understanding of how fluid flow influences biofilm biology since turbulence will likely disrupt metabolite and signal gradients as well as community stratification.

The Effect of Use of a Sonic Power Toothbrush and a Manual Toothbrush Control on Plaque and Gingivitis.

OBJECTIVES: To compare the ability of the Philips Sonicare DiamondClean power toothbrush and the ADA Reference manual toothbrush to reduce plaque and gingival inflammation by routine manual toothbrush users. METHODS: This was a randomized, single-blind, parallel-design study. Eligible subjects were generally healthy non-smokers who exhibited mild to moderate gingivitis upon study entry. Enrolled subjects were randomly allocated to commence twice-daily home use of either a Philips Sonicare DiamondClean (DiamondClean) power toothbrush or an ADA reference manual toothbrush (MTB) for a period of four weeks. Clinical safety and efficacy were assessed after a two- and four-week period of home use. Statistical analysis was performed for the modified intent to treat (mITT) population using a mixed model with the Baseline score as a covariate. RESULTS: A total of 182 volunteers were screened, 144 (72 per treatment) were randomized, and 142 subjects completed this study. Following four weeks of use, the Least Square (LS) Mean SE) percent reduction in surface plaque was 34.9% (1.8) for DiamondClean and 8.0% (1.7) for MTB, (p < 0.0001). At the same four-week time point, the LS Mean (SE) percent reduction in gingival inflammation for DiamondClean was 25.5% (1.9) and 19.1% (1.9) for MTB (p = 0.0213). For gingival bleeding, the LS Mean (SE) percent reduction in sites with gingival bleeding for DiamondClean was 57.4% (3.06) and 31.4% (3.04) for MTB (p < 0.0001). CONCLUSIONS: The Philips Sonicare DiamondClean power toothbrush was statistically significantly more effective than a manual toothbrush in reducing supragingival plaque, gingival inflammation, and gingival bleeding following a four-week period of home use. Both products were safe for home use.

An Evaluation of Plaque and Gingivitis Reduction Following Home Use of Sonicare FlexCare Platinum with Premium Plaque Control Brush Head and a Manual Toothbrush.

OBJECTIVES: To assess the effect of the Philips Sonicare FlexCare Platinum with Premium plaque control brush head on gingival inflammation, bleeding, and supragingival plaque reduction following a six-week period of home use compared to a manual toothbrush. METHODS: This was a randomized, single-blind, parallel-design clinical trial. Subjects included in the study were routine manual toothbrush users who were generally healthy non-smokers, aged 18-65 years, with mild to moderate gingivitis. Subjects with advanced periodontal disease, excessive gingival recession, and heavy deposits of calculus or rampant decay were excluded from the study. Eligible participants were dispensed either Philips Sonicare FlexCare Platinum with Premium plaque control brush head (PC), or an ADA Reference manual toothbrush (MTB) for twice-daily home oral hygiene procedures for six weeks. Efficacy measures included the Lobene and Soparker Modification of Quigley and Hein Plaque Index (MPI), the Modified Gingival Index (MGI), and Gingival Bleeding Index (GBI). Safety was evaluated by oral examination and subject report. Efficacy and safety were assessed at Baseline, and at two and six weeks following product home use. RESULTS: Of 154 subjects randomized, 143 subjects completed the study. For the primary endpoint, MGI at Week 2, statistically significantly larger reductions in MGI were observed for PC versus MTB, p < 0.0001. The adjusted mean reduction and standard error estimates (SE) for MGI, expressed as percent reduction versus Baseline to Week 2, were 41.73% (2.00%) for PC and 7.38% (2.02%) for MTB. Statistically significant differences were also observed for MPI and GBI at Week 2, and for all metrics at Week 6. CONCLUSIONS: Philips Sonicare FlexCare Platinum with Premium plaque control brush head statistically significantly reduces gingival inflammation, gingival bleeding, and plaque following two and six weeks of home use, compared to manual tooth brushing alone.

A Comparison of the Effect of Two Power Toothbrushes on the Gingival Health and Plaque Status of Subjects with Moderate Gingivitis.

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.

Gingival Health and Plaque Regrowth Response Following a Four-Week Interdental Hygiene Intervention.

OBJECTIVES: To compare the efficacy of three adjunct interproximal cleaning methods versus a manual toothbrush alone on gingivitis, and demonstrate that the Philips Sonicare AirflossPro™ interproximal (IP) cleaning device provides a similar reduction in gingivitis and plaque compared to string floss. METHODS: A randomized, single-blind, parallel-design study was conducted on generally healthy adults exhibiting mild to moderate gingivitis. Eligible subjects were non-smokers, aged 18-65 years, with ≥ 0.5 per the Rustogi Modified Navy Plaque Index (RMNPI) and a Gingival Bleeding Index (GBI) of ≥ 1 on at least 10 sites. Eligible subjects were randomly assigned to use one of four oral hygiene regimens: manual toothbrush (MTB) alone; MTB plus string floss (SF); MTB plus Philips Sonicare AirflossPro used with Cool Mint Listerine® Antiseptic (AFPL); and MTB plus Philips Sonicare AirflossPro used with BreathRx™ (AFPB). Subjects were followed over a 28-day home-use period, with follow-up visits for efficacy and safety conducted at Days 14 and 28. All subjects were instructed to use the MTB twice daily and perform interproximal cleaning once daily, if assigned. Study efficacy endpoints included the Modified Gingival Index (MGI), Rustogi Modified Navy Plaque Index, and the Gingival Bleeding Index. RESULTS: Of 290 randomized subjects, 287 were followed to Day 14 and 286 were followed to Day 28. For the primary endpoint at Day 14, significantly larger reductions in MGI were observed in each of the three IP cleaning groups compared to MTB alone (p < 0.001). The adjusted mean reductions and standard error estimates (SE) for MGI expressed as a percent reduction from Baseline at Day 14 were: 0.22% (0.55%) for MTB; 4.30% (0.44%) for SF; 4.55% (0.45%) for AFPL; and 4.20% (0.44%) for AFPB. A non-inferiority test comparing AirflossPro to SF showed AirflossPro to be non-inferior to SF (p < 0.001). CONCLUSIONS: The addition of interproximal cleaning to manual tooth brushing statistically significantly reduces gingivitis and plaque compared to manual tooth brushing alone. Among the adjunct interproximal cleaning regimens, AirflossPro provides a similar reduction in gingivitis and plaque to string floss. All study regimens were safe on oral tissues.

Microbial Profiling in Experimentally Induced Biofilm Overgrowth Among Patients With Various Periodontal States.

BACKGROUND: This study measures microbial composition changes during biofilm overgrowth and subsequent removal among patients with various states of periodontal disease. METHODS: In this prospective cohort study, 175 participants with various periodontal states (five biofilm-gingival interface [BGI] groups) abstained from oral hygiene while using an acrylic stent. At day 21, participants reinstituted oral hygiene and were followed for 4 weeks. Clinical parameters were recorded, and subgingival plaque samples were analyzed at baseline, peak of induction (day 21), and resolution using 16S rRNA probes (human oral microbe identification microarray [HOMIM]). Using the change score (peak at induction minus baseline) for bleeding on probing and probing depth (PD), the patients were separated into high and low clinical responders. RESULTS: At baseline, synergistetes were more abundant in moderate and severe periodontitis (BGI-P2 and -P3) compared to mild periodontitis (BGI-P1), health (BGI-H), and gingivitis (BGI-G) (P = 0.005). Overall, at day 21 there was an increase in HOMIM scores of firmicutes (P ≤0.001), fusobacteria (P = 0.003), proteobacteria (P ≤0.001), synergistetes (P = 0.04), and bacteroidetes (P ≤0.001). At resolution, these phyla returned to baseline, except for synergistetes. Levels of synergistetes were significantly higher at day 21 (P ≤0.0001) and resolution (P = 0.0002) for high clinical responders compared to low responders. CONCLUSION: The association of synergistetes as a baseline predictor of incident PD increase, as well as the higher levels at day 21, indicates a pathogenic role for these organisms in disease progression in addition to the previously characterized fusobacteria, proteobacteria, firmicutes, and bacteroidetes.

Smoking decreases structural and functional resilience in the subgingival ecosystem.

AIMS: Dysbiotic microbial communities underlie the aetiology of several oral diseases, especially in smokers. The ability of an ecosystem to rebound from the dysbiotic state and re-establish a health-compatible community, a characteristic known as resilience, plays an important role in susceptibility to future disease. The present investigation was undertaken to examine the effects of smoking on colonization dynamics and resilience in marginal and subgingival biofilms. MATERIALS AND METHODS: Marginal and subgingival plaque and gingival crevicular fluid samples were collected from 25 current and 25 never smokers with pre-existing gingivitis at baseline, following resolution, after 1, 2 4, 7, 14 and 21 days of undisturbed plaque formation and following resolution. 16S cloning and sequencing was used for bacterial identification and multiplexed bead-based flow cytometry was used to quantify the levels of 27 immune mediators. RESULTS: Smokers demonstrated an early pathogenic colonization that led to sustained pathogen enrichment with periodontal and respiratory pathogens, eliciting a florid immune response. Smokers also demonstrated greater abundance of pathogenic species, poor compositional correlation between marginal and subgingival ecosystems, and significantly greater pro-inflammatory responses following resolution of the second episode of disease. CONCLUSIONS: The ability of the subgingival microbiome to "reset" itself following episodes of disease is decreased in smokers, thereby lowering the resilience of the ecosystem and decreasing its resistance to future disease.

Salivary biomarkers in a biofilm overgrowth model.

BACKGROUND: The purpose of this study is to determine whether baseline salivary inflammatory biomarkers could discriminate between different clinical levels of disease and/or detect clinical changes over a 3-week stent-induced biofilm overgrowth (SIBO) period. METHODS: A total of 168 participants were enrolled in a 21-day experimental gingivitis investigation and grouped according to clinical measures of periodontal status of health and diseased individuals representing each of five biofilm gingival interface (BGI) periodontal groups: 1) health, all probing depth (PD) <3 mm and bleeding on probing (BOP) <10%; 2) gingivitis, all PD <3 mm and BOP ≥10%; 3) periodontitis (P)1, ≥1 site with PD >3 mm and BOP ≤10%; 4) P2, ≥1 site with PD >3 mm and BOP >10% but ≤50%; and 5) P3, ≥1 site with PD >3 mm and BOP >50%. Stents were used to prevent plaque removal during brushing over one maxillary and one mandibular posterior dental sextant for 21 days. Clinical periodontal parameters and unstimulated saliva were collected at screening, baseline, and each week during SIBO. Saliva samples were assessed for levels of 13 different biomarkers by multiplex immunoassay. RESULTS: Higher salivary levels of interleukin (IL)-1ß, matrix metalloproteinase (MMP)-3, MMP-8, MMP-9, and neutrophil gelatinase-associated lipocalin (NGAL) were found in diseased groups compared with the healthy group at baseline. Conversely, higher IL-1 receptor antagonist (ra) levels were found in healthy patients at baseline. In addition, during SIBO, MMP-1, tissue inhibitor of metalloproteinase (TIMP)-1, and TIMP-2 levels increased across all participant groups. A stepwise linear regression model using all salivary biomarkers demonstrated that, at baseline, increased IL-1ra (P = 0.004) and IL-6 (P = 0.009) were significantly associated with change in PDs during SIBO. CONCLUSIONS: In summary, this investigation supports salivary levels of IL-1ra and IL-6 as potential indicators for PD changes during induced gingival inflammation. In addition, participants from the BGI-P3 group (severe periodontitis) demonstrated elevated baseline levels of IL-1ß, MMP-3, MMP-8, MMP-9, and NGAL compared with the other study groups, strengthening the relevance of participants' biologic phenotype on expression of salivary biomarkers.