The Proclaim device, with a 3D printed mouthpiece, is a specialty oral irrigator that uses up to 60 high-precision jets for a personalized and automated 7-second deep clean.
Modern oral hygiene methods are based on old technology that requires regular repetition of instructions and skill in mastering. Often, patients are unable to provide the proper level of oral hygiene corresponding to the periodontal condition, and the accompanying disorder can lead to limitation of visits to the dentist and other necessary preventive measures.
Interproximal cleaning, including the use of dental floss and devices such as water flosses, is underutilized in dental practices. This limited adoption may be due to the experience patients have with these products. Recent advances in imaging and 3D printing have made interproximal cleaning more customizable, precise, and convenient. The Custom-Jet Oral Health System uses 3D printing to create a customized, easy-to-use oral hygiene preventative for daily use at home. Unlike floss, water flosses, or other devices, the custom mouthpiece delivers targeted interproximal cleaning as part of your daily oral care routine in just 7 seconds per day (Photo 1).
Photo 1: The Proclaim Custom-Jet Oral Irrigator from Fresh Health features a water station and a custom mouthpiece.
Proclaim Custom-Jet Oral Health System
Proclaim's disease prevention technology uses 3D printing to create a custom-fitted mouthpiece that is embedded with up to 60 precisely positioned water jets located in the facial and lingual interproximal areas (Photo 2). Once activated, approximately 650 ml of water is pulsed through the system for approximately 7 seconds. This creates a targeted cleaning stream that simultaneously targets the facial and lingual interproximal areas and the gingival margins of the mandible and maxilla (Photo 3).
Photo 2: The design of the Proclaim mouthpiece, in particular the placement of the nozzles.
Photo 3: A sample of a custom-made mouthpiece showing the trajectory of the water.
The process for making a custom mouthpiece is simple. First, an intraoral scan is taken at a dental office or X-ray center to be used to make the custom mouthpiece. A variety of intraoral scanners can be used, including the iTero (Align Technology), TRIOS (3Shape), Medit, Virtuo Vivo (Straumann), Primescan (Dentsply Sirona), and Carestream Dental scanners. With the exception of the unique bite registration block, the scanning process is routine and similar to that used to make clear aligners, and of course, covers both arches (Photo 4). The resulting STL files are uploaded via a secure cloud portal. Image processing and transfer can be completed in under 15 minutes.
Photo 4: Sample intraoral scan with bite block.
Specialized software is then used to create a custom mouthpiece with nozzles precisely targeted to the interproximal areas on both the facial and lingual sides. Each mouthpiece is designed to fit the patient's unique oral anatomy and is therefore one of a kind. Once the design is complete, medical grade resin is used to 3D print each mouthpiece (Photo 5).
Photo 5: Mouthpieces on the build tray after 3D printing.
Finally, after further processing and quality control, the finished mouthpieces are connected to the hydrostation. These products are then delivered directly to the patient along with a sample of Proclaim concentrated tincture for oral administration to give them a feeling of freshness and therefore compliance. In total, the entire process usually takes several weeks.
Clinical Results
The Proclaim Custom-Jet Health System oral hygiene device has been evaluated in a variety of forums, including practical evaluations and randomized clinical trials. The results of a controlled clinical trial with positive and negative evaluations were particularly impressive. In this study, after 30 days, participants assigned to the Proclaim group showed significant improvement in all five study endpoints (plaque, gingival inflammation, marginal gingival bleeding, bleeding on probing, and pocket depth).
Favorable significant results were evident early on (at the first post-baseline assessment at 15 days). Comparisons between groups were equally impressive, with the Proclaim group demonstrating a highly significant reduction in gingival health scores, 12 times better than the floss group (positive control group, Photo 6). Participants in the floss group received verbal and written instructions on proper flossing technique. In terms of dental practice, first-time participants in this clinical trial incorporated Proclaim into their daily oral hygiene routine without clinical problems or significant side effects.
Photo 6: Improvement from baseline after 30 days of Proclaim use.
Important for the patient and clinical practice
Many dental practices are adopting digital technology to improve the quality of care for their patients and, in turn, grow their business. Intraoral scanners are becoming increasingly popular. Practices with compatible intraoral scanning capabilities can become Proclaim partners, which helps differentiate the practice and attract new patients.
Many patients can benefit from personalized home care. The most obvious of these are those with ongoing oral hygiene issues between dental visits, as well as those with a history of certain periodontal, restorative, or aesthetic procedures. Additionally, Proclaim can be a great fit for people with limited mobility and dexterity, as well as those who rely on fixed appliances.
At a minimum, Proclaim is indicated for individuals with a stable dentition, with at least a first or second premolar or first molars in each quadrant. Due to the individual fit and precision of the product, this appliance may not be suitable for patients with unstable dentition, such as children or those undergoing active denture or orthodontic treatment. However, Proclaim may be useful for many patients following denture or orthodontic treatment, as it helps them maintain their newly restored dentition.
One unexpected benefit is that in all cases the custom mouthpiece is easy to use. The 7-second procedure provides unprecedentedly fast care throughout the entire arch. In addition, the mouthpiece can be easily inserted or removed from the control handle (photo 7). This allows multiple users to use one device at home.
Photo 7: Proclaim in use.
Conclusion
Digital scanning and 3D printing technologies have become widespread in dentistry to improve workflow and facilitate patient care. Using these technologies, the new Proclaim Custom-Jet oral hygiene system, which has already demonstrated impressive results, offers the world's first individual approach to oral hygiene at home with daily use in just a few seconds.