New Clinical Study Shows the World’s First Customized and Fully Automated Oral Health System, When Paired with Brushing, Significantly Reduces Clinical Signs of Gingivitis Compared to Brushing and Manual Flossing in Just 7 Seconds of Active Treatment
MOUNTAIN VIEW, Calif. – Groundbreaking clinical results show use of a new transformative
at-home-use device can significantly reduce plaque accumulation and the clinical signs of
gingivitis, including gingival inflammation and bleeding, and improve both pocket depth and
bleeding on probing compared to traditional tooth brushing and flossing.
Introducing the Proclaim™ Custom-Jet Oral Irrigator, the world’s first automated oral health
system customized to fit each patient’s dentition for a more precise, thorough cleaning at home
with just 7 seconds of active treatment. Proclaim uses the latest in digital intraoral scanning and
advanced 3D-printing technology to design and produce a custom mouthpiece with up to 60
precisely-placed pressurized jets along both facial and lingual interproximal sites. The jets send
pulsing water with precision between the teeth and below the gum line. The fully automated oral
irrigator provides a 360-degree deep cleaning at the push of a button for consistent results with
every use. Unlike existing manual solutions, this innovation was specially designed to offer
patients a more sustainable and easier way to improve and maintain their oral health care habits
at home, ultimately resulting in better patient outcomes.
“For the nearly half of Americans struggling with some form of gum disease, there’s no doubt
this first-of-its-kind advancement will be life changing,” said Dr. Robert Eber, Clinical Professor
Director of Clinical Research, University of Michigan School of Dentistry, and Diplomate and Past
Chair, American Board of Periodontology. “The results of this clinical study prove that
technological innovation can truly revolutionize and improve a routine, age-old practice with the
push of a button. I predict it will positively impact hygiene behaviors and patient outcomes for
generations to come.”
Study participants in the brushing plus Proclaim group experienced significantly greater
reductions in all measured indices and achieved a more effective clean compared to those in
the manual tooth brushing only group.
More importantly, the brushing plus Proclaim group showed highly significant improvements in
all measures versus brushing plus daily flossing, the positive control in the clinical study. In that
regard, after 30 days use, the overall results showed Proclaim was:
- 12.8 times more effective in reducing gingival inflammation
- 8.9 times more effective in reducing gingival bleeding
- 9.3 times more effective in reducing plaque levels
In the “hard-to-reach” interproximal areas, Proclaim was:
- 13.2 times more effective in reducing gingival inflammation
- 10.0 times more effective in reducing gingival bleeding
- 7.9 times more effective in reducing plaque levels
In addition, the Proclaim group showed a 5.4 times greater pocket depth reduction and a 1.6
times greater bleeding on probing reduction compared to the brushing and flossing group. All of
these differences were statistically significant and achieved after only 30 days of 7-second daily
use of the novel Proclaim technology. No adverse events were reported. The published clinical
trial results can be accessed here.
For dental professionals with access to an intraoral scanner who want to be one of the first to be
considered to try out the Proclaim Custom-Jet Oral Irrigator for themselves or to offer it to their
patients, please visit Professional.ProclaimHealth.com for more information. Some of these
Proclaim demos will also be live and in person at the following upcoming industry shows:
American Association of Orthodontists (AAO) in Chicago, IL, American Academy of Cosmetic
Dentistry (AACD) in Grapevine, TX, and California Dental Association (CDA) in Anaheim, CA.
About Proclaim™ by Fresh Health Inc.
Founded in 2017, Fresh Health Inc. is dedicated to pioneering breakthroughs in personalized, automated, everyday solutions that transform oral care routines for the healthiest lives. The company’s first product, the Proclaim Custom-Jet Oral Health System is the world’s first and only custom fit, fully-automated solution that delivers 360 degree deep cleaning between the teeth and below the gumline in just 7 seconds of active treatment, every time. Proclaim is the most advanced at-home oral health system ever created and has been clinically shown to reduce gum disease in just 30 days. Headquartered in Mountain View, California, the team of world-class engineers, clinicians and designers at Fresh Health Inc. were brought together to develop breakthrough technologies that enable sustainable habits for the healthiest lives, starting with a focus on eliminating preventable oral diseases. Proclaim is not yet commercially available.
For more information, visit Professional.ProclaimHealth.com.
192 adult subjects completed the 30-day randomized, examiner-blinded clinical trial, with 61 subjects randomly assigned to the control group (brushing only), 65 subjects randomly assigned to the brushing + floss group, and 66 subjects randomly assigned to the brushing + Proclaim Oral Care System group. All subjects were provided with an ADA reference soft manual toothbrush and ADA accepted fluoride toothpaste and were instructed to brush 2x daily according to their usual habits. Subjects in the Proclaim group visited the research site once daily to use the Custom-Jet Oral Irrigator at the maximum setting (with water). Those in the floss group were instructed to floss once daily at home. Gingivitis was assessed at six sites per tooth using the Modified Gingival Index (MGI) and bleeding on a marginal probing via Gingival Bleeding Index (GBI), and plaque was measured using the Rustogi Modified Navy Plaque Index (RMNPI). Additionally, periodontal probing depth (PPD) and bleeding on probing (BOP) were measured at six sites per tooth. The clinical trial referenced was conducted at Salus Research in Fort Wayne, Indiana, an ADA-qualified research site.
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