Computer-Aided Design and Manufacture of Intraoral Splints: A Potential Role in Cleft Care

Background: Nasoalveolar molding is a nonsurgical modality for the treatment of cleft lip and palate that uses an intraoral splint to align the palatal shelves. Repeated impressions are needed for splint modification, each carrying risk of airway obstruction. Computer-aided design and manufacturing (CAD/CAM) has the ability to simplify the process. As a precursor to CAD/CAM splint fabrication, a proof-of-concept study was conducted to compare three-dimensional splints printed from alginate impressions versus digital scans. We hypothesized that intraoral digital scanning would compare favorably to alginate impressions for palate registration and subsequent splint manufacture, with decreased production times.

Methods: Alginate and digital impressions were taken from 25 healthy teenage volunteers. Digital impressions were performed with a commercially available intraoral scanner. Plaster casts made from alginate impressions were converted to Standard Triangle Language files. Patient-specific matched scans were evaluated for total surface area with the concordance correlation coefficient. Acrylic palatal splints were three-dimensionally printed from inverse digital molds. Subjective appliance fit was assessed using a five-point scale.

Results: A total of 23 participants were included. Most subjects preferred digital impression acquisition. Impression methods showed moderate agreement (concordance correlation coefficient 0.93). Subjects rated splints from digital impressions as having a more precise fit (4.4 versus 3.9). The digital approach decreased impression phase time by over 10-fold and overall production time by 28%.

Conclusions: CAD/CAM has evolved extensively over the past two decades and is now commonplace in medicine. However, its utility in cleft patients has not been fully realized. This pilot study demonstrated that CAD/CAM technologies may prove useful in patients requiring intraoral splints.