The novel Proclaim 3D-printing solution for customised at-home oral hygiene

Interproximal cleaning, including flossing and the use of devices like irrigators, is a prime example of under-utilisation in dental care. This limited adoption may be attributed to the experiences patients have in using these products. Recent developments in imaging and 3D printing have enabled a level of customisation, accuracy and convenience for interproximal cleaning. A novel product, Proclaim Custom-Jet Oral Health System (Fresh Health), uses 3D printing to create a custom-fit, easy-to-use preventive oral health solution for daily at-home use. Unlike flossing, generic irrigation devices or other approaches, the custom mouthpiece affords targeted interproximal cleaning as part of the daily oral care routine in just 7 seconds a day (Fig. 1).

Proclaim Custom-Jet Oral Health System

Proclaim’s preventive health technology uses 3D printing to generate a custom-fit mouthpiece embedded with up to 60 precision-placed water jets located at the facial and lingual interproximal sites (Fig. 2). After activation, approximately 650 ml of water is pulsed through the system over about 7 seconds. This creates a targeted cleaning stream directed simultaneously at the facial and lingual interproximal sites and gingival margins in the mandible and the maxilla (Fig. 3).

The process of producing the custom-fit mouthpiece is straightforward. First, intra-oral scans are taken at a dental practice or scanning centre for use in fabrication of the custom mouthpiece. Various intra-oral scanners may be used, including iTero (Align Technology), TRIOS (3Shape), Medit scanners, Virtuo Vivo (Straumann), Primescan (Dentsply Sirona) and Carestream Dental scanners. Except for a unique bite registration block, the scanning process is routine and similar to that used in fabricating clear aligners and, of course, encompasses both arches (Fig. 4). The STL files obtained are uploaded via a secure cloud-based portal. The imaging and image transfer can be completed in-office in less than 15 minutes.

Finally, after post-processing and quality control, the completed mouthpieces are paired with the hydro station. These products are then shipped directly to the patient, along with a sample of Proclaim’s concentrated oral infusion, to promote a feeling of freshness and thus compliance. In total, delivery typically takes a few weeks.

Clinical performance

The Proclaim Custom-Jet Oral Health System has been evaluated in a range of forums, including practice-based assessments and randomised clinical trials. The results of a controlled clinical trial with positive and negative controls were particularly impressive. In that study, participants assigned to the Proclaim group showed significant improvements in all five study end points (plaque, gingival inflammation, marginal gingival bleeding, bleeding on probing and pocket depth) after 30 days.

Favourable significant outcomes were apparent early (at the first post-baseline assessment at 15 days). Between-group comparisons were similarly impressive, with the Proclaim group showing highly significant reductions in gingival health endpoints versus flossing (the positive control group), including up to 12-fold improvements relative to daily flossing (Fig. 6). The participants in the flossing group were given verbal and written instruction on proper flossing technique. Pertinent to dental practice, first-time users in this clinical trial incorporated Proclaim into their daily oral hygiene process without clinical problems or significant adverse events.

There are a myriad of patients who may benefit from customised at-home care. Of these, the most obvious are patients with persistent between-visit oral hygiene issues, and those with a history of certain periodontal, restorative or aesthetic treatments. In addition, Proclaim may be a great fit for individuals with reduced mobility or dexterity or those with fixed appliances.

At minimum, Proclaim is indicated for individuals with a stable dentition with at least a first or second premolar or first molar in each quadrant. Owing to the custom-fit and precision of the product, the approach may not be suitable for patients with an unstable dentition, such as children or individuals actively undergoing prosthodontic or orthodontic treatment. However, Proclaim may be beneficial for many patients after prosthodontic or orthodontic treatment to help them maintain their newly restored dentition.

One unexpected benefit is that, in all cases, the custom mouthpiece is easy to use. The 7-second delivery affords unprecedentedly rapid full-arch care. In addition, the mouthpiece can be easily inserted or removed from the control handle (Fig. 7). This enables multiple users in a household with a single device.

Conclusion

Digital scanning and 3D-printing technology have been widely adopted in dentistry to improve the workflow and facilitate patient care. Using these technologies, the novel Proclaim Custom-Jet Oral Health System offers the first-ever customised approach for at-home oral hygiene, and impressive results have been observed when it is used for only a few seconds daily.