Dentistry, Volume 5 - Issue 1, April 2018

Promoting periodontal health: an evidence-based look at home oral hygiene Back

Periodontal disease

It may be surprising to learn that, for adults over the age of 30 in the USA, there is a chronic disorder with a prevalence of over 47%.1 This percentage translates to roughly 64 million US adults, and this chronic disorder is periodontal disease. Globally, the incidence of severe periodontal disease, as estimated by the World Health Organization (in adults aged 35–44), is 5–20%.2 The effects of the chronic inflammatory state of periodontal disease include tooth loss, masticatory dysfunction and effects on quality of life.3

Furthermore, those affected by periodontal disease may potentially experience negative sequelae in their overall health. Continued research efforts aimed at exploring the relationship between periodontal disease and other conditions of an inflammatory character – diabetes,4 for example – deepen our understanding of the complex relationship between the status of our oral and general health. No longer is the oral cavity an environment that is seemingly isolated from the rest of the body; the complex microbial communities that populate the interface between what is ‘outside’ and what is ‘inside’ our very selves – and our resultant immune response – may have significant effects on other aspects of our health.

Recognizing this evidence, the European Federation of Periodontology (EFP) issued a manifesto5 several years ago, in which entities across the spectrum of public health were called upon to collaborate and support measures aimed at the treatment and prevention of periodontal disease. When a patient presents with sites of severe periodontal disease and multiple comorbidities, interventions may be extensive and cross disciplinary boundaries. At the other end of the spectrum, there are those patients who present to the oral surgery with reasonably good indicators of oral health. Though at disparate ends of the range, thorough, home oral hygiene is, nonetheless, essential; either to restore or to sustain oral health. When faced with these conversations – these teaching opportunities with patients – how should ongoing prevention and management efforts be directed?

Restoring and sustaining oral health

Patient education that has its basis in evidence is an important place to start. A recommendation to change a patient’s lifestyle, or to optimize his or her oral hygiene habits, should not be done lightly. As a health practitioner, one stands to directly influence the health of one’s patients in the short and long term. Those methods used in the dental surgery, those tools and procedures one instructs patients to use at home, make a difference. In this important role, what is the best way to be the most effective educator and advocate for your patient’s health?

Evidence-based decision making is a valuable tool that can be put to use. It takes into account three important perspectives: first, one’s observations as an expert. As you spend the day evaluating the hygiene and lifestyle habits of those across the spectrum of health and disease, what do you consistently recognize as the habits of those who are healthy? And those who are not? Second, the patient perspective matters. What are the steps necessary for a given patient to be successful? As each patient presents with unique challenges, how can your recommendations enable a particular patient to achieve and sustain oral health? Third, how does published research support one’s aims to educate and make recommendations that are proven to work? The intersecting center of these three perspectives represents the crux of evidence-based decision making.

Recognizing that two of these three elements have their basis in one’s expertise and observations, the third requires external input and a query to available scientific literature. The body of scientific work contributing to the collective understanding of oral health and oral disease evolves as fast as publications reach one’s desk and inbox. New measurement methodologies, novel discoveries and more sensitive analysis techniques enable the continued scientific quest for evidence with greater resolution, repeatability or generalizability.

As an industry partner in public health, efforts to preserve oral health and help prevent periodontal disease, Philips Sonicare takes the development of its home oral hygiene products seriously. A patient in need of a more rigorous home-care regimen is often recommended to augment their home care with new tools and procedures. And, while you may observe for yourself whether a given patient benefits from use of a Sonicare device, its systematic evaluation for the purpose of providing clear safety and efficacy outcomes is a fundamental part of the evidence-based decision-making process.

Providing evidence

Consistent with this mindset, in March 2017, Philips Sonicare published five peer-reviewed articles in a special issue of the Journal of Clinical Dentistry (JCD). The articles provide details on four clinical trials and a meta-analysis, which were conducted to evaluate the safety and efficacy of use of Philips Sonicare oral hygiene devices. The publication of these articles provides dental professionals with a transparent look at the evidence-based ethos that guides the development of products in the Sonicare portfolio.

Dr Maha Yakob, Global Director of Professional Relations and Scientific Affairs, Philips Oral Healthcare, made the following observation, ‘At Philips, we take the value of health very seriously. Providing evidence that our products restore and sustain oral health is at the core of our mission to improve lives.’

Building on this observation, Dr Marilyn Ward, Director, Clinical and Scientific Affairs, Philips Oral Healthcare, comments, ‘The clinical validation of product safety and efficacy is an integral part of the innovation process at Philips Oral Healthcare. Our products have to earn their place in the portfolio, and that only happens through rigorous clinical testing.’

The publications contained in the JCD special issue focus on the effects of use of Philips Sonicare hygiene devices on changes to the gingival health and plaque status of clinical trial subjects following a period of home use. By following the applicable laws and standards of clinical trial conduct, reporting and analysis, the published outcomes provide a basis of evidence of the Philips mission to improve lives by preserving and improving health.

Summaries of published studies

Study 1: Comparison of gingivitis reduction and plaque removal by Philips Sonicare DiamondClean and a manual toothbrush6

The objective of this study was to compare the safety and efficacy of the Philips Sonicare DiamondClean power toothbrush and an American Dental Association (ADA) reference manual toothbrush, following a four-week period of home use.

The study was randomized and parallel, with generally healthy, non-smoking subjects aged 18–70 years, who had mild-to-moderate levels of gingival inflammation. Efficacy metrics included the assessment of gingival tissue inflammation (using the modified gingival index [MGI]), gingival bleeding (using the gingival bleeding index [GBI]) and surface plaque (using the modified plaque index [MPI]). The study examiners were blinded to the treatment assignment of subjects. Safety assessment included oral tissue examination and documentation of any adverse changes to existing subject restorations.

A total of 142 subjects (70 in the Sonicare group, 72 in the manual toothbrush group) completed the study. The mean age of subjects was 42.1 years.

Gingival inflammation outcomes (MGI)

Following four weeks of product use, the least square (LS) mean (standard error [SE]) for the Sonicare DiamondClean group was 1.57 (0.04), and for manual toothbrush it was 1.71 (0.04), p=0.0106. Expressed as percent reduction versus baseline, this is 25.5% reduction for DiamondClean, and 19.1% for manual toothbrush (Figure 1a).

Figure 1

Figure 1. LS mean for (a) MGI, (b) GBI, (c) MPI, percent reduction from baseline to week 4

Gingival bleeding outcomes (GBI)

Following four weeks of product use, the LS mean (SE) for the Sonicare DiamondClean group was 12.4 (0.89) and for manual toothbrush it was 20.0 (0.88), p<0.0001. Expressed as percent reduction versus baseline, this is 57.4% reduction for DiamondClean, and 31.4% for manual toothbrush (Figure 1b).

Surface plaque outcomes (MPI)

Following four weeks of product use, the LS mean (SE) for the Sonicare DiamondClean group was 1.84 (0.05), and for manual toothbrush it was 2.58 (0.05), p<0.0001. Expressed as percent reduction versus baseline, this is 34.9% reduction for DiamondClean, and 8.0% for manual toothbrush (Figure 1c).

Safety outcomes

There were eight reported safety events from three study subjects, none of which was serious. There were no observed adverse effects to restorative materials, including crowns, composites or veneers.

Study conclusions

The Philips Sonicare DiamondClean power toothbrush was significantly more effective than a manual toothbrush at reducing supragingival plaque, gingival inflammation and gingival bleeding following a four-week period of home use. Both products were safe for home use.

Study 2: Comparison of plaque and gingivitis reduction by Philips Sonicare FlexCare Platinum with Premium plaque control brush head and a manual toothbrush7

Objective and methods

The objective of this study was to compare the safety and efficacy of the Philips Sonicare FlexCare Platinum power toothbrush and an ADA reference manual toothbrush, following a six-week period of home use.

The study was randomized and parallel, with generally healthy, non-smoking subjects aged 18–65 years, who had mild-to-moderate levels of gingival inflammation. Efficacy metrics included the assessment of gingival tissue inflammation (MGI), gingival bleeding (GBI) and surface plaque (MPI). Study examiners were blinded to the treatment assignment of subjects. Safety assessment included oral tissue examination and subject diary reporting of any adverse events.

A total of 154 subjects (76 in the Sonicare group, 78 in the manual toothbrush group) completed the study. The mean age of subjects was 40.5 years.

Gingival inflammation outcomes (MGI)

The LS mean (SE) overall percent reduction from baseline following six weeks of home use was 45.79% (2.06) for Sonicare FlexCare Platinum, and −0.71% (2.08) for manual toothbrush. The difference between products was statistically significant, p<0.0001 (Figure 2a).

Figure 2

Figure 2. LS mean for (a) MGI, (b) GBI, (c) MPI, percent reduction from baseline to week 6

Gingival bleeding outcomes (GBI)

The LS mean (SE) overall percent reduction from baseline following six weeks of home use was 58.36% (3.55) for Sonicare FlexCare Platinum, and −3.14% (3.57) for manual toothbrush. The difference between products was statistically significant, p<0.0001 (Figure 2b).

Surface plaque outcomes (MPI)

The LS mean (SE) overall percent reduction from baseline following six weeks of home use was 46.55% (2.46) for Sonicare FlexCare Platinum, and −1.58% (2.48) for manual toothbrush. The difference between products was statistically significant, p<0.0001 (Figure 2c).

Safety outcomes

There were two adverse events reported in the study. Both events occurred in the manual toothbrush group. The events were mild in severity and assessed by the investigator as unlikely to have been related to the study.

Study conclusions

The Philips Sonicare FlexCare Platinum power toothbrush was significantly more effective than a manual toothbrush at reducing gingival inflammation and gingival bleeding and plaque following a six-week period of home use. Both products were safe for home use.

Study 3: The effectiveness of manual versus high-frequency, high-amplitude, sonic-powered toothbrushes for oral health: a meta-analysis8

Objective and methods

The objective of this investigation was to compare the everyday efficacy of high-frequency, high-amplitude, sonic-powered toothbrushes versus manual toothbrushes on plaque removal and gingivitis reduction through a meta-analysis of short-term clinical studies.

To identify eligible studies, searches were performed in databases of scientific publications (Embase, MEDLINE, BIOSIS, Inspec, PQ-SciTech, Compendex, SciSearch), as well as the International Association of Dental Research (IADR) database. Qualifying studies were randomized, controlled clinical trials that evaluated the effect of both manual and sonic-powered toothbrushes on surface plaque and gingivitis. Data were extracted from qualifying studies, and investigators were contacted for additional information, if needed. The meta-analysis was then performed to compute standardized mean difference (SMD) and 95% confidence intervals (CIs) using random-effects models to quantify differences. (Note: this method is consistent with the statistical operations performed by the Cochrane collaboration.9)

Results

Overall, 18 studies, comprising 1870 subjects, were included. The results demonstrated that high-frequency, high-amplitude, sonic-powered toothbrushes resulted in statistically significantly greater reductions in plaque (SMD −0.89, 95% CI −1.27, −0.51) and gingivitis (SMD −0.67, 95% CI −1.01, −0.32), when compared to manual toothbrushes (Figure 3). In practical terms, this equates to approximately 20% more plaque removal and 10% greater decrease in gingivitis.

Figure 3

Figure 3. SMD and CIs, (a) plaque removal, (b) gingivitis reduction. Figure adapted from De Jager et al. J Clin Dent 2017;28(Spec Iss A):A13–28.8

Conclusions

High-frequency, high-amplitude, sonic-powered toothbrushes decreased plaque and gingivitis significantly more effectively than manual toothbrushes in everyday use in studies lasting from four weeks to three months.

Study 4: An assessment of gingivitis reduction and plaque removal by Philips Sonicare DiamondClean with Premium Plaque Control brush head and Oral-B 7000 with CrossAction brush head10

Objective and methods

The objective of this study was to compare the safety and efficacy of two power toothbrushes: the Philips Sonicare DiamondClean with Premium Plaque Control brush head and the Oral-B 7000 with CrossAction brush head, following a six-week period of home use.

The study was prospective, randomized and parallel, with generally healthy, non-smoking subjects aged 18–65 years, who had moderate-to-severe levels of gingival inflammation. Efficacy metrics included the assessment of gingival tissue inflammation (MGI), gingival bleeding (GBI) and surface plaque (MPI). Study examiners were blinded to the treatment assignment of subjects. Safety assessment included oral tissue examination and subject diary reporting of any adverse events.

A total of 284 subjects (142 in the Sonicare group, 142 in the Oral-B group) completed the study. The mean age of subjects was 38.6 years.

Gingival inflammation outcomes (MGI)

Following six weeks of product use, the LS mean (SE) for the Sonicare group was 1.43 (0.04), and for the Oral-B group it was 1.91 (0.04), p<0.0001. Expressed as percent reduction versus baseline, this is 45.68% reduction for Sonicare, and 26.83% for Oral-B (Figure 4a).

Figure 4

Figure 4. LS mean for (a) MGI, (b) GBI, (c) MPI, percent reduction from baseline to week 6

Gingival bleeding outcomes (GBI)

Following six weeks of product use, the LS mean (SE) for the Sonicare group was 0.13 (0.01), and for the Oral-B group it was 0.22 (0.01), p<0.0001. Expressed as percent reduction versus baseline, this is 75.81% reduction for Sonicare, and 58.76% for Oral-B (Figure 4b).

Surface plaque outcomes (MPI)

Following six weeks of product use, the LS mean (SE) for the Sonicare group was 1.80 (0.04), and for the Oral-B group it was 2.30 (0.04), p<0.0001. Expressed as percent reduction versus baseline, this is 37.58% reduction for Sonicare, and 20.70% for Oral-B (Figure 4c).

Safety outcomes

There were eight adverse events reported in the study. Six of these were assessed as mild and two were moderate in severity. Among the eight events, three occurred in the Sonicare group, five in the Oral-B group. All events resolved by the end of the study.

Study conclusions

The Philips Sonicare DiamondClean power toothbrush was significantly more effective than the Oral-B 7000 power toothbrush at reducing gingival inflammation, gingival bleeding and plaque following a six-week period of home use. Both products were safe for home use.

Study 5: A study to assess the effects of Philips Sonicare AirFloss Pro, when used with antimicrobial rinse, on gum health and plaque removal11

Objective and methods

The objective of this study was to compare the safety and efficacy of three adjunct interdental cleaning methods versus a manual toothbrush alone, on gingivitis, bleeding and plaque; and to demonstrate that the Philip Sonicare Airfloss Pro interproximal (IP) cleaning device provides a similar reduction in gingivitis and plaque compared to use of string floss.

The four-week study was prospective, randomized and parallel, with generally healthy, non-smoking subjects aged 18–65 years, who had mild-to-moderate levels of gingival inflammation. There were four treatment groups: manual toothbrush alone (MTB), manual toothbrush plus string floss (SF), manual toothbrush plus Sonicare Airfloss Pro used with Listerine (AF+L), and manual toothbrush plus Sonicare Airfloss Pro used with BreathRx (AF+B). Efficacy metrics included the assessment of gingival tissue inflammation (MGI), gingival bleeding (GBI) and surface plaque (RMNPI). Study examiners were blinded to the treatment assignment of subjects. Safety assessment included oral tissue examination and subject diary reporting of any adverse events.

A total of 290 subjects (51 in the MTB group, 79 in the SF group, 80 in the AF+L group and 80 in the AF+B group) completed the study. The mean age of subjects was 35.6 years.

Gingival inflammation outcomes (MGI)

Following four weeks of product use, the overall LS mean (SE) percent reduction from baseline was 1.10% (0.72) for MTB, 11.41% (0.58) for SF, 9.54% (0.58) for AF+L and 8.52% (0.58) for AF+B. All three IP cleaning regimens were statistically significantly more effective than manual tooth brushing alone, p<0.001 (Figure 5a).

Figure 5

Figure 5. Study 5 results: LS mean for (a) MGI, (b) GBI, (c) RMNPI, percent reduction from baseline to week 4

At week 4, the contrast test for inferiority between the IP cleaning regimens (SF versus AF+L and AF+B) was rejected (p<0.001), indicating non-inferiority of the IP cleaning regimens.

Gingival bleeding outcomes (GBI)

Following four weeks of product use, the overall LS mean (SE) percent reduction from baseline was 4.03% (2.85) for MTB, 43.31% (2.30) for SF, 40.49% (2.31) for AF+L, and 36.79% (2.30) for AF+B. All three IP cleaning regimens were statistically significantly more effective than manual tooth brushing alone, p<0.001 (Figure 5c).

Surface plaque outcomes (RMNPI)

Following four weeks of product use, the overall LS mean (SE) percent reduction from baseline was 5.70% (1.08) for MTB, 26.48% (0.87) for SF, 23.96% (0.87) for AF+L, and 22.41% (0.86) for AF+B. All three IP cleaning regimens were statistically significantly more effective than manual tooth brushing alone, p<0.001 (Figure 5b).

At week 4, the contrast test for inferiority between the IP cleaning regimens (SF versus AF+L and AF+B) was rejected (p<0.001), indicating non-inferiority of the IP cleaning regimens.

Safety outcomes

There were four adverse events reported in the study. All four events were mild in severity, ‘possibly related’ to study products (two events in AF+B, one event in SF, one event in AF+L), and observed to resolution.

Study conclusions

The use of an IP cleaning regimen as an adjunct to manual tooth brushing improves gum health and reduces plaque significantly better than manual tooth brushing alone.

Among the adjunct IP cleaning regimens, Sonicare Airfloss Pro used with mouth rinse (either Philips Sonicare BreathRx or Listerine Cool Mint) dispensed to the IP space was shown to improve gum health and reduce plaque as well as the use of string floss.

Partnering with dental professionals

Following the publication of these articles, Philips went a step further and convened a forum in which to solicit feedback about the publications, and the reported study procedures, techniques and methodologies. Collecting and reporting data, while important, is not enough. Did the experimental designs have an effect on what the data ultimately demonstrated? Were the statistical methods and measurement methodologies robust? Are there alternate endpoints that should be considered in the future that are more meaningful and impactful to practitioners and patients?

Questions of this ilk were put to a meeting of Key Opinion Leaders (KOLs) who were asked to critically examine, and provide unfiltered comments on, each of the five published articles. The meeting was convened in Vienna, Austria, just prior to the 2017 Continental Europe International Association of Dental Research (CE IADR) conference. Philips was a Gold sponsor for the IADR conference, participating as an exhibitor and sponsoring a symposium on oral/systemic health. There were ten participants, from nine different countries, in attendance at this break-out KOL meeting.

Following, are excerpted comments from the lively discussion that ensued.

Michael Noack:
‘Really convincing data of the Sonicare technology was presented and published. And I think these studies are convincing. They help me, and what is more important, I use the Sonicare toothbrush myself and I inform my patients – in a shared decision-making process – which is the right way to go. However, now I can really have a nice answer if patients are asking me: can you really be sure that this will help me?’

 Prof Iain Chapple

Robyn Watson:
‘I do think the studies are very helpful and very supportive. I think it will help clinicians to make those evidence-based decisions.’

Karen Davis:
‘I think the studies are absolutely valid, in terms of giving clinicians confidence that they are recommending something that is safe, effective, that clinically can achieve the outcomes they are desiring.’

With each innovation at Philips Oral Healthcare, our collective efforts have a single overriding goal: to improve lives by providing your patients the very best tools for their oral health. Subjecting our products to rigorous evaluation in a clinical-trial setting is the implicit standard set to establish that this is the case. Dr Yakob comments: ‘We invite you to read the entire Special Issue of the Journal of Clinical Dentistry so that you can critically examine this process for yourself. I am deeply committed to an innovation trajectory that starts with the voice of the dental professional, and ends with clinically validated, meaningful results. The five manuscripts in the Special Issue are excellent proof-points of this process.’

All told, the data in these five studies present the outcomes of the analysis of hundreds of thousands of data points. Together, these data points provide an evidence-base that has been aimed at demonstrating the safety and efficacy of Sonicare powered devices to standard-of-care manual tooth brushing, powered tooth brushing, or interdental cleaning. Going forward, we will take the important feedback we received from our KOL meeting, thus to further improve how Philips Sonicare can partner with dental professionals to develop products that have been shown, with clinical trial evidence, to help preserve and improve the periodontal health of patients.

References

  1. Eke PI, Dye BA, Wei L, et al. Prevalence of periodontitis in the United States: 2009 and 2010. J Dent Res 2011;91:914–20.
  2. Petersen PE, Bourgeois D, Ogawa H, et al. The global burden of oral diseases and risks to oral health. Bull World Health Organ 2005;83:661–9.
  3. Buset SL, Walter C, Friedmann A, et al. Are periodontal diseases really silent? A systematic review of their effect on quality of life. J Clin Periodontol 2016;43:333–44.
  4. Graziani P, Gennal S, Solilni A, Petrini M. A systematic review and meta-analysis of epidemiologic observational evidence on the effect of periodontal disease on diabetes: an update of the review of the EFP-AAP workshop. J Clin Periodontol 2018;45:167–87.
  5. EFP manifesto (www.efp.org/efp-manifesto/manifesto.html; accessed 31 January 2018).
  6. Delaurenti M, Ward M, Souza S, et al. The effect of use of a sonic power toothbrush and a manual toothbrush control on plaque and gingivitis. J Clin Dent 2017;28(Spec Iss A):A1–6.
  7. Jenkins W, Souza S, Ward M, et al. An evaluation of plaque and gingivitis reduction following home use of Sonicare FlexCare Platinum with Premium Plaque Control brush head and a manual toothbrush. J Clin Dent 2017;28(Spec Iss A):A7–12.
  8. De Jager M, Rmaile A, Darch O, Bikker JW. The effectiveness of manual versus high-frequency, high-amplitude sonic powered toothbrushes for oral health: a meta-analysis. J Clin Dent 2017;28(Spec Iss A):A13–28.
  9. Yaacob M, Worthington H, Deacon S, et al. Powered versus manual toothbrush for oral health. Cochrane Database Syst Rev 2014;17, CD002281.
  10. Starke M, Delaurenti M, Ward M, et al. An assessment of gingivitis reduction and plaque removal by Philips Sonicare DiamondClean with premium plaque control brush head and Oral-B 7000 with CrossAction brush head. J Clin Dent 2017;28(Spec Iss A):A29–35.
  11. Mwatha A, Olson M, Souza S, et al. A study to assess the effects of Philips Sonicare Airfloss Pro, when used with antimicrobial rinse, on gum health and plaque removal. J Clin Dent 2017;28(Spec Iss A):A36–44.