Abstract
Purpose The primary prevention of periodontitis is controlling gingivitis daily. The study objective was to compare the efficacy of a pulsating water flosser to a pulsating water flosser infused with air microbubbles on clinical signs of inflammation and plaque.
Methods One hundred and five participants were enrolled in this single-blind, single-center, parallel, four-week, IRB/IEC-approved clinical trial. Participants were randomly assigned to one of three groups: water flosser (WF) plus manual toothbrush, water flosser infused with microbubbles of air (MBWF) plus manual toothbrush, or dental floss (DF) plus manual toothbrush. Bleeding on probing (BOP), Modified Gingival Index (MGI), and Rustogi Modification Navy Plaque Index (RMNPI) scores were recorded at baseline, 2-weeks, and 4-weeks.
Results All participants completed the study (n=105). All groups showed a statistically significant reduction for BOP, MGI, and RMNPI at 4-weeks (p<0.05, except DF marginal RMNPI). The WF group showed a statistically significant greater reduction in whole mouth BOP (0.41) compared to MBWF (0.32) and DF (0.19). This was also true for MGI (0.37, 0.30, and 0.20, respectively) and RMNPI (0.13, 0.11, and 0.06, respectively) (p<0.05 for all comparisons). No adverse events were reported.
Conclusion This study demonstrates that a manual toothbrush and water flosser, with or without microbubbles, is an effective oral care regimen for controlling gingivitis over four weeks.
INTRODUCTION
Periodontitis is a widespread public health concern that affects over half of the adult population worldwide. This disease is characterized by inflammation and infection of the periodontium. In individuals susceptible to periodontal disease, microbial imbalances in the biofilm can play a significant role in the development and progression of the disease.1,2 The primary prevention of periodontitis is the effective management of gingivitis.3
Consistent daily oral hygiene should include devices that aid the patient in eliminating or disturbing clinically visible and microscopic biofilm from all areas around the teeth.3,4 The toothbrush is the most common tool for plaque removal on exposed tooth surfaces. This means there is undisturbed plaque interproximally and subgingivally, providing an environment for initiating dental caries and periodontal infections. Evidence for using a toothbrush alone often shows it is inadequate when used by individuals at home.4-6
A systematic review found a weighted mean of 42% plaque removal after a single brushing exercise with a manual toothbrush, indicating that people routinely leave plaque on their teeth.5 Power brushes have shown slightly better results, with a weighted mean of 46% plaque removal after a single brushing exercise.6 A meta-review showed powered toothbrushes had a small but statistically significant advantage over manual toothbrushes of 11% - 21% for plaque scores and 6% - 11% for gingivitis scores.4 This data shows room for improvement, and brushing alone is insufficient for controlling gingivitis.
Manual and power toothbrushes are not designed to reach interproximal and subgingival areas, prompting the need for an additional device intended for this purpose. Dental floss, interdental brushes, elastomeric picks, wooden interdental aids, and water flossers, also known as oral irrigators and dental water jets, have been recommended as a supplement to tooth brushing to access the interproximal and subgingival areas around a tooth.7
Daily oral hygiene is an essential part of maintaining optimal oral health. Water flossers are a type of oral hygiene tool initially created to supplement toothbrushing and assist in removing plaque and debris from the mouth.8 Early research in the 1990s focused on using water flossers to reach below the gingival margin and deliver antimicrobial agents to help combat periodontal disease.9-11
Since then, more recent studies have compared the efficacy of water flossers to other interdental cleaning devices, such as dental floss, interdental brushes, and air floss.12-19 These studies have shown that water flossers are more effective than traditional flossing in removing plaque and reducing gingival inflammation.12-16 Additionally, water flossers are more comfortable and easier to use than conventional floss, especially for individuals with orthodontic appliances or dental restorations.14,16,20-22
Overall, water flossers have become a popular oral hygiene tool for people looking for an alternative to traditional flossing or those with specific dental needs. They effectively remove plaque and help maintain a healthy oral environment, along with regular brushing and professional dental care.
Not all water flossers have the exact mechanism of action, and manufacturing specifications will vary from company to company. A pulsating oral irrigator removes biofilm by shear forces that overcome the biofilm matrix’s tensile strength without damaging the tooth surface’s integrity.23
Some models attach to a faucet and deliver a steady stream of water. Published evidence that a steady-stream oral irrigator can significantly improve oral health indices has not been found. Another oral irrigator is designed to have the water pass over a magnet with the intent to magnetize the water.24,25 The belief is that the magnetized water can change the structure of the deposit (plaque and calculus), reducing adherence. Research with the magnetic water floss showed no difference in the gingival index or plaque scores compared to the same device without a magnet.25 Two studies using an accretion index, measuring the location of calculus and plaque as one deposit, reported a significantly better reduction for the magnetized group.24,25 It is important to note that the accretion index has not been validated. The use of a magnet was based on information from other industries. Magnetized water used in the oil industry for removing deposits is an unproven theory.26-28
A different type of oral irrigator delivers pulsating water infused with air microbubbles. The underlying premise of adding air to the water is the potential to harm the anaerobic bacteria or remove it entirely.29 In vitro testing using artificial saliva with bubbles reported enhanced biofilm removal compared to the fluid without bubbles.30,31 The studies also evaluated the liquid’s velocity, bubble size, and gas fractions. Low-velocity bubbles showed no difference compared to liquid alone, and large bubbles at low gas fractions seemed the most effective in one study.30 In another study, the highest removal was due to shear forces with the thermodynamic forces that pull bacteria from a surface when it comes in contact with the bubble.31
The primary objective of this randomized controlled trial (RCT) was to compare the effectiveness of a pulsating water flosser to a pulsating water flosser infused with microbubbles on reducing bleeding sites after 4-weeks. The secondary objectives were to compare the study groups’ efficacy in reducing gingival inflammation and plaque scores. Brushing and flossing were used as a positive control group.
METHODS
Study Design
This was a single-blind, single-center, parallel, four-week, IRB/IEC-approved clinical trial.32 The study was conducted under Good Clinical Practice guidelines (GCP), the ethical principles of the Declaration of Helsinki (revised in 2013, Fortaleza, Brazil)33, and local regulations in Ontario, Canada. Screening and data collection occurred from August 19, 2021 – September 3, 2021, at All Sum Research Center, Mississauga, Ontario, Canada. A database of over 5,000 volunteers in and around the Mississauga, Ontario, area was used to recruit participants for this study. One hundred and five participants were informed about the study objectives, duration, requirements, and their involvement over the phone. Interested participants were scheduled for screening to confirm they still met the inclusion criteria. The participants were provided a consent form for review and signature during the screening visit. They also completed a medical history form. All the participants who were scheduled were eligible and enrolled in the study and underwent baseline data collection and allocation to one of three treatment groups. Participants received a unique study number to ensure the privacy, anonymity, and blinding of the examiner, data recorder, and assistant. Participants were monetarily compensated for their time at the end of the study or pro-rated if they chose to withdraw. The study was registered on www.clinicaltrials.gov (NCT05766995) and this paper followed the CONSORT guidelines34 for reporting randomized controlled trials and TiDierR guidelines35 for reporting intervention description and replication. This study was approved by the All Sum Research Center Independent Review Board (IRB) (#2021-WP-1).
One hundred and five (105) participants were randomized and enrolled in the study (Figure 1). Participants were not blind to their product allocation as they are readily available at retail and branded on the product. The study director (JGQ) was responsible for allocation concealment. The examiner (CRG), recorder (JGQ), and assistant (RK) were blinded to the treatment randomization, group allocation, and records of earlier examinations at subsequent visits.
Study Flow Chart
Oral soft and hard tissue examinations, gingivitis, bleeding, and plaque assessments were conducted at baseline, 2-weeks, and 4-weeks. Plaque samples were obtained from a subset of participants (n=36) randomly assigned from each treatment group (n=12). Samples were taken at baseline and 4-weeks, stored under controlled temperature, and shipped to a laboratory for analysis. Details for the microbial sampling and outcomes are reported in a separate paper.
At the baseline visit, participants were told to brush twice daily, as they usually do, with the manual toothbrush and toothpaste provided, for two minutes using a smartphone or timer in the morning and evening. They were instructed to use their water flosser according to the written manufacturer instructions provided or dental floss following written instructions after brushing in the evening (Appendix S1). The first brushing and interdental cleaning exercise was done under supervision. All subsequent brushing and interdental cleaning exercises were done at home and unsupervised. The dispensing/oral hygiene staff reiterated not to use other oral hygiene products and not to reveal their product assignments or discuss their impressions with the examiners, recorder, or assistant (Appendix S2).
Participants were instructed to refrain from all oral hygiene for 12 hours and not to eat, drink, or chew gum for 4 hours prior to each evaluation visit and agreed to comply with the conditions and schedule of the study. There were no changes to the original protocol.
Study Population
Individuals who signed an informed consent, were between 18 – 75 years old, had a minimum of 20 natural teeth with 5 in each quadrant, and were scorable on the facial and lingual surfaces, as determined by the clinical examiner, were enrolled in the study. Participants were nonsmokers and presented with a baseline plaque index score of ≥0.60 as measured by the Rustogi Modification Navy Plaque Index (RMNPI)36, Modified Gingival Index (MGI)37 score of ≥1.75, and bleeding on probing score of ≥50%. Participants agreed to forgo dental prophylaxis or any other elective, non-emergency dental procedures during the study. Participants also confirmed they would abstain from using chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at-home use), and all other oral hygiene products other than the distributed devices. Time requirements were explained to each subject, and they agreed to comply with the conditions and schedule of the study (Appendix S3).
Participants had no physical limitation or restriction that precluded everyday use of study devices, no history of allergic reaction to the toothpaste used, and were systemically healthy with no clinical evidence of oral pathology, caries, extensive restorations, or chronic neglect. Participants who required preventive antibiotic treatment or used antibiotics within one month prior to baseline visit or other medication known to affect periodontitis status were not enrolled in the study.
Study Products
The test and comparison study devices were distributed with written manufacturer’s instructions with the toothpaste and toothbrush used in this study. All study products were put in a non-transparent bag to ensure blinding of the examiner, recorder, and assistant. Participants in group 1 received the Waterpik® ION Water Flosser (WF) (Water Pik, Inc., Fort Collins, CO, USA) (Appendix S4). The Classic jet tip was used on setting 8 for this study.
Participants in group 2 received the Oral-B® Water Flosser Advanced (MBWF) (Procter & Gamble, Cincinnati, OH, USA) (Appendix S4). The targeted stream position on the jet tip was used on the medium setting, and continuous mode was used for this study.
Participants in group 3 received Reach® waxed unflavored dental floss (DF) (Kenvue, formerly Johnson & Johnson Consumer Health, Skillman, NJ, USA). All participants received an American Dental Association (ADA) standard toothbrush (Oral-B 35, Procter & Gamble, Cincinnati, OH, USA) and fluoride toothpaste (Colgate® Cavity Protection, Colgate-Palmolive Company, New York, NY, USA).
Toothbrushes, toothpaste, dental floss, and Oral-B water flossers were purchased at retail. The sponsor supplied the Waterpik® water flossers.
Clinical Assessment
One examiner (CRG), a practicing dentist and experienced clinical examiner, collected all the data at each time point. Following the ADA Seal of Acceptance clinical guidelines for powered interdental cleaners, manual interdental cleaners, and toothbrushes, the examiner collected data at baseline, 2-weeks, and 4-weeks.38,39 Normal findings for perioral area/lips; buccal, labial, and sublingual mucosa; free and attached gingival tissue, tongue, palate hard/soft, uvula, oropharynx, and other soft/hard tissue were noted during the examination of the oral cavity at baseline, 2-weeks, and 4-weeks.
The findings were recorded on the case report forms (CRF) and signed by the examiner. Bleeding on probing (BOP) was assessed at six sites for every tooth as positive or negative. Binary scores for each site were recorded within 30 seconds for mesiobuccal, buccal, distobuccal, mesio-lingual, lingual, distolingual sites. Mean scores were determined by adding the number of bleeding sites and dividing by the number of probing sites.
Gingival inflammation was assessed using the Modified Gingival Index (MGI)37 with a scale of 0 – 4, where 0 = absence of inflammation, and 4 = severe inflammation. The plaque was scored using the Rustogi Modification of the Navy Plaque Index (RMNPI)36, which divides the tooth surface into 9 segments on the buccal and lingual surfaces. This method allows the calculation of separate scores for the proximal region and the gingival margin area for the whole mouth or just on the facial and lingual surfaces (Appendix S5).
Sample Size and Statistical Analysis
A computer-generated randomization scheme (www.random.com) was prepared by the study statistician (RS) and provided to the study director (JGQ). Based on the randomization schedule, participants were assigned in a 1:1:1 ratio to one of three oral hygiene regimen groups. Group 1 received a water flosser + manual toothbrush (WF), Group 2 received a water Flosser + manual toothbrush (MBWF), and Group 3 received dental floss + manual toothbrush (DF). A statistical power analysis was conducted using nQuery (Boston, MA, USA). There was 80% power to detect at least a 0.7 effect size (mean difference between treatment groups divided by the pooled SD for the mean difference) for a two-sided test with 5% Type 1 error, with 35 evaluable subjects per treatment group. This corresponds to detecting a large effect size corresponding to a meaningful superiority in bleeding reduction for the active treatment.
The initial comparison was the mean change within the three groups using one-way analysis of variance (ANOVA). The arcsine transformation stabilized the variances of the percentage data.40 The between-groups comparison was done using paired contrasts for three treatment groups ANOVA. A p-value of <0.05 was considered statistically significant.
RESULTS
All participants completed the study (n=105). No adverse events were reported or identified during the study. The final study demographics are shown in Table I.
Subject demographics (n=105)
Bleeding on Probing
All baseline bleeding scores were comparable between treatment groups (p>0.532). All treatment groups showed a significant reduction in bleeding from baseline to 4-weeks for all areas measured (p>0.001). The mean reduction for whole mouth scores was 0.41 for WF (95% CI ±0.0152), 0.32 for MBWF (CI 95% ±0.0156), and 0.19 for DF (95% CI ±0.00861) (Table IIa). The difference between WF and MBWF was statistically significant for whole mouth, proximal, and marginal area (p=0.021 or less). WF was twice as effective as DF for whole mouth, proximal, and marginal area (p<0.001). Two-week data and 4-week data for other areas measured are shown in Appendix S6 and S7. Mean change percentages and differences between groups are shown in Appendix S8.
Bleeding on Probing: Change scores and standard deviation from baseline to 4-weeksa
Modified Gingival Index
All MGI scores were comparable between treatment groups at baseline (p>0.103), except for facial proximal sites (p=0.041). All groups had a statistically significant reduction from baseline to 4-weeks for all MGI endpoints (p<0.001). The mean reduction for whole mouth MGI scores was 0.37 for WF (95% CI ±0.0325), 0.30 for MBWF (95% CI ±0.0368), and 0.20 for DF (95% CI ±0.0325) (Table IIb). The difference between WF and MBWF was statistically significant for whole mouth and proximal area (p=0.003 or less). WF was statistically significantly better for whole mouth, proximal, and marginal area compared to DF (p<0.001). Two-week data and 4-week data for other areas measured are shown in Appendix S6 and S7. Mean change percentages and differences between groups are shown in Appendix S8.
Modified Gingival Index: change scores and standard deviations from baseline to 4- weeksa
Plaque Index
Plaque scores for all treatment groups were comparable at baseline (p>0.372), except for the whole mouth and facial surface (both; p=0.013). These baseline differences were attributed to slightly higher baseline plaque scores for the MBWF group. Changes from baseline to 4-weeks for RMNPI showed whole mouth differences of 0.13 for WF (95% CI 0.0152), 0.11 for MBWF (95% CI ±0.0149), and 0.06 for DF (95% CI ±0.00961) (Table IIc). The most significant difference between the WF and MBWF groups was for proximal scores (0.28 vs 0.16, respectively). The WF was statistically significantly more effective for whole mouth, proximal, and marginal areas compared to DF (p=0.009 or less) and whole mouth and proximal area compared to MBWF (p=0.046 or less). Two-week data and 4-week data for other areas measured are shown in Appendix S6 and S7. Mean change percentages and differences between groups are shown in Appendix S8.
Modified Rustogi Navy Plaque Index: Change scores and standard deviations from baseline to 4-weeksa
DISCUSSION
This was a randomized, controlled, parallel, single-blind clinical trial for a duration of 4-weeks. The study’s primary objective was to compare the effectiveness of two water flossers, one delivering pulsating water and one delivering pulsating water infused with microbubbles, paired with a manual toothbrush, on reducing bleeding sites at 4-weeks. The secondary study objectives were to compare the effectiveness of the water flossers on the reduction in gingival and plaque scores at 4-weeks. A 2-week data point was also assessed. Manual toothbrushing and dental floss were included in the study as a positive control. All groups showed a statistically significant reduction from baseline to 4-weeks in BOP, MGI, and RMNPI. The WF treatment group was statistically better at reducing overall bleeding, gingival, and plaque scores than MBWF and DF.
The protocol followed the ADA guidelines for interdental cleaners for measuring plaque and gingivitis reductions.38,39 The methodology, inclusion criteria, and intervention are similar to several other published clinical trials.13-19 This is important to evaluate reproducibility and provide a base of RCT for systematic reviews and meta-analysis. It is also important to compare different devices that fall under a specific category. The power toothbrush category has two primary mechanisms of action: oscillating-rotating (OR) motion and sonic motion. Each action is proven more effective at removing plaque and improving bleeding and gingival scores than a manual toothbrush.4 A meta-analysis found that subjects using OR toothbrushes improved gingival health faster and with greater efficiency in subregions over sonic and manual brushes over six months.41 Shapes of interdental brush, floss material, woodsticks, and elastomeric interdental cleaners have also been compared.42-46 Different mechanisms of action, manufacturer specifications, and tip designs exist in the oral irrigation category. Product research on one device cannot be assumed to support another. This study provides information about two different devices in the oral irrigation category.
Network meta-analysis can evaluate a variety of interventions by using direct and indirect comparisons from the included studies, comparing different devices that have not been previously compared in an RCT.47 A network meta-analysis of interproximal oral hygiene methods reported oral irrigator (water flosser, dental water jet) and interdental brush ranked high in the reduction of gingival inflammation scores as measured by gingival index (GI) or BOP.48 Subsequently, a multi-outcome network meta-analysis reported that the oral irrigator and interdental brush ranked high for both gingival index and bleeding on probing.49 In both meta-analyses dental floss and woodsticks ranked low for reducing the gingivitis scores.
Consumers depend on their dental professionals to provide recommendations on self-care products. Products that are easy to use and take minimal time are preferred. Dental professionals seek to find the right combination and the least number of tools to accomplish the goal of good oral health and patient compliance. Water flossing is easier to use than dental floss as it is not technique-sensitive or requires a high standard of skill. The water flosser tip is slowly moved along the gingival margin, whereas the floss needs to be contoured around the tooth, ensuring that it does not traumatize the interdental papilla. Lack of confidence in flossing, difficulty with technique, and preference for any device that is not floss has been documented.50-52 Interdental brush size depends on the embrasure space, and multiple sizes or shapes may be necessary to clean between all the teeth. Patient acceptance of oral irrigation is not well documented in the literature, nor are there 6 months or longer clinical trials comparing other interdental aids. A survey of water flosser users may also provide information on preference and compliance.
Studies on a pulsating water flosser show a statistically significant reduction in BOP and MGI over 4-weeks.12,14,15,17-19,53-56 Comparisons to dental floss,12-16 interdental brush,54-56 and air flosser18-19 have been reported with the pulsating water flosser demonstrating superior benefits for individuals with gingivitis. This is the first published study to compare a pulsating water flosser to a pulsating water flosser infused with air microbubbles on clinical signs of inflammation, gingival bleeding, and plaque reductions.
The differences between the WF and DF in this study were in line with other studies conducted since 2004, demonstrating that WF is superior for reducing plaque, gingival bleeding, and gingival inflammation scores.12-17 Studies using water enriched with microbubbles of oxygen are limited. A randomized controlled trial showed a reduction in plaque, MGI, and gingival bleeding from baseline, but there was no difference compared to brushing alone after 8-weeks.57 Another study evaluated a three-part oral hygiene regimen of brushing, irrigation, and mouth rinse in an orthodontic population compared to brushing alone, with positive results favoring the regimen.58 An electric toothbrush and water flosser with air microbubbles reported statistically significant differences in gingival index and BOP compared to toothbrushing alone after 8-weeks.59 These studies did not include another water flosser group for comparison.
It is evident from this study that using a water flosser with or without microbubbles can help improve gingival health in people with gingivitis. Both types showed improvement in clinical parameters, but the addition of microbubbles did not provide a benefit over the non-microbubble pulsating water flosser. The bubble size, velocity, and gas fractions for the MBWF water flosser are unknown and may have contributed to the outcome.
A pulsating water flosser that provided microbubbles in the fluid was modified using an oxygen microbubble generator to measure the removal of facultative anaerobic bacteria. In this case, it was possible to control for multiple variables and combinations including motor speed, nozzle diameter, number of nozzle holes, flow volume, discharge velocity, oxygen microbubble diameters and dissolved oxygen levels. The study found that several combinations were effective in removing the bacteria. The greatest effect was seen with a higher number of nozzle holes, a wider nozzle opening, and higher speeds.29
Efficacy for both devices was due to fluid dynamic shear forces that removed the biofilm. Longer studies, sub-analysis, and more information about microbubble production and delivery can provide additional information and test the impact over time and the potential of reaching gingival health by site or subject.
Limitations
Blinding a subject to the devices is not possible because they are commonly available on the market and visually very different from each other. The 4-week study duration adhered to the American Dental Association requirement to demonstrate efficacy measured by changes in gingival health. Longer study durations may speak to issues concerning motivation and patient compliance with home care regimens and questions regarding the impact of routine use of a water flosser to reach a state of periodontal health as outlined in the 2017 World Workshop new classification scheme for periodontal and peri-implant diseases and conditions.60
Studies including patients with periodontal conditions would help to enhance knowledge regarding the effectiveness of water flossing in promoting or achieving periodontal health.
CONCLUSION
This RCT study measured differences between two water flossers currently on the market. The results show that a manual toothbrush and water flosser, with or without the infusion of air microbubbles, is an effective oral care regimen for improving gingival health over 4 weeks. Infusing air microbubbles into the water did not demonstrate an advantage over a traditional pulsating water flosser device.
Using a water flosser device is easy and effective for improving gingival health. New products with difference mechanism of action, different delivery methods, or specifications need to be compared. Each product needs to be tested individually and differences between devices should be clinically meaningful.
ACKNOWLEDGEMENTS
The authors would like to thank Jason Qaqish, Ranjit Kaur, Judy DeSouza, Debbie Fincher and Sharon Beaumont for their expertise and attention to detail on this study during the COVID-19 pandemic and Joy Void-Holmes for initial ideas for the manuscript.
Appendix S1. Instructions for brushing (all groups) and flossing
Brushing
Brush twice a day for two minutes using your smart phone or the timer provided. Brush using your normal technique once in the morning after breakfast and once in the evening before bedtime.
Interdental Cleaning: Dental Floss
Wind 18″ of floss around middle fingers of each hand. Pinch floss between thumbs and index fingers, leaving a 1″ – 2″ length in between. Use thumbs to direct floss between upper teeth.
Keep a 1″ – 2″ length of floss taut between fingers. Use index fingers to guide floss between contacts of the lower teeth.
Gently guide floss between the teeth by using a zig-zag motion. Do not snap floss between your teeth. Contour floss around the side of the tooth.
Slide floss up and down against the tooth surface and under the gumline. Floss each tooth thoroughly with a clean section of floss.
Floss your teeth once a day after brushing in the evening.
Appendix S2. Schematic illustration of information provided to the participants
Appendix S3. Study schedule from baseline to 4-weeks
Appendix S4. Products used in study
Waterpik® Ion Water Flosser (WF) (Water Pik, Inc., Fort Collins, CO, USA)
Oral-B® Water Flosser Advanced (MBWF) (Procter & Gamble, Cincinnati, OH, USA)
Appendix S5. Indices for measurement of gingival bleeding, inflammation, and plaque
Bleeding on Probing
0 = No Bleeding 1 = Bleeding Number of Sites Bleeding ÷ Total Number of Sites = % of Bleeding
Modified Gingival Index
Rustogi Modification of the Navy Plaque Index
Plaque is assessed for each tooth area (A through I) and scored using the following scale: 0 = Plaque is assessed for each tooth area (A through I) and scored using the following scale: 0 = absent, and 1 = present. Facial and lingual surfaces of all gradable teeth are scored and a mean plaque index is calculated for each subject at each examination. Subjects’ scores were calculated for the whole mouth (A through I), along the gingival margin (A through C), and at the proximal (approximal) areas (D and F).
Appendix S6. Mean change scores from baseline to 2-weeksa
Bleeding on probing
Modified Gingival Index
Rustogi Modification of Navy Plaque Index
Appendix S7. Mean change scores for subareas from baseline to 4-weeksa
Bleeding on Probing
Modified Gingival Index
Rustogi Modification of Navy Plaque Index
Appendix S8. Mean percent reductions from baseline and comparisons between groups at 4-weeksa
Bleeding on Probing
Modified Gingival Index
Plaque Index
Footnotes
NDHRA priority area, Client level: Oral health care (health promotion: treatments, behaviors, products).
DISCLOSURES
The authors declare no conflicts of interest. DML was an employee of Water Pik, Inc., Fort Collins, CO, USA, during execution of the study.
All Sum Research Center, Ltd., located in Mississauga, Ontario, Canada, executed the study through a Water Pik, Inc. research grant. All Sum Research Center, Ltd.’s research team has previously conducted studies for multiple oral care companies. Those manufacturers include, but are not limited to, Procter & Gamble (Oral-B®, Braun®), Church & Dwight (Arm & Hammer), Johnson & Johnson Oral Care, Ranir® Oral Care (A Perrigo® Company), Colgate®, & Burst® Oral Care.
RS is the sole proprietor of Reinhard Schuller Consulting. Past corporate and educational affiliations include Addiction Research Foundation, University of Toronto, Bloorview McMillian Rehab Centre, Pfizer, and Ventana Clinical Research Corporation. Primary consulting is for the oral care and pharmaceutical industry.
- Received April 28, 2023.
- Accepted September 12, 2023.
- Copyright © 2023 The American Dental Hygienists’ Association














