Nasoalveolar molding (NAM) is an accepted treatment strategy in presurgical cleft therapy. The major drawbacks of the treatment listed in the literature relate to the time of the treatment and the coordination of the required interdisciplinary team of therapists, parents, and patients. To overcome these limitations, we present the automated RapidNAM concept that facilitates the design and manufacturing process of NAM devices, and that allows the virtual modification and subsequent manufacture of the devices in advance, with a growth prediction factor adapted to the patient's natural growth. The RapidNAM concept involves (i) the prediction of three trajectories that envelope the fragmented alveolar segments with the goal to mimic a harmonic arch, (ii) the extrusion from the larger toward the smaller alveolar segment along the envelope curves toward the harmonic upper alveolar arch, and (iii) the generation of the NAM device with a ventilation hole, fixation pin, and fixation points for the nasal stents. A feasibility study for a vector-based approach was successfully conducted for unilateral and bilateral cleft lip and palate (CLP) patients. A comparison of the modified target models with the reference target models showed similar results. For further improvement, the number of landmarks used to modify the models was increased by a curve-based approach.
Nasoalveolar molding (NAM) aims to improve nasal symmetry with a nasal stent in cleft lip and palate (CLP) patients. When plates have to be exchanged because of dentoalveolar growth or cleft reduction, the nasal stent has to be mounted onto a new plate. This procedure elongates visiting hours for patients and parents or requires second treatment sessions. This study introduces a quick-lock additive manufacturing solution for chairside nasal stent exchange called RapidNAM. A novel taping retention pin has been designed that enables nasal stent insertion. Patients with unilateral CLP were included in this study. Plaster models were digitalized and measured by two independent observers. Two methods of CAD/CAM-molding therapies were compared: (i) conventional adhesion of a nasal stent (CAD/CAM NAM); (ii) quick-lock system in which the nasal stent was transferred to another plate (RapidNAM). CAD/CAM NAM and its refinement RapidNAM significantly increased the cleft-side nasal height and tilted the nose towards symmetry. The quick-lock system minimizes wire adaptations, since the pre-existing stent can be reused. The new nasal stent development seems a feasible solution to minimize visiting hours but with clinically satisfactory results. This new nasal stent system combines traditional elements of NAM with CAD/CAM-technology.
Computer-aided design and computer-aided manufacturing (CAD/CAM) technology has been implemented in the treatment of cleft lip and palates (CLP) by several research groups. This pilot study presents a technique that combines intraoral molding with a semi-automated plate generation and 3D-printing. The clinical results of two intraoral molding approaches are compared. This is the first clinical investigation of semi-automated intraoral molding. Our study included newborns with unilateral CLP. Plaster models were digitalized and measured by two independent observers. Two methods of CAD/CAM-assisted intraoral molding were compared: (i) stepwise manual design of molding plates (conventional CAD/CAM-intraoral molding) and (ii) a semi-automated approach with an automated detection of alveolar ridges (called RapidNAM) assisted by a graphical user interface (GUI). Both approaches significantly narrowed the clefts and resulted in a harmonic alveolar crest alignment. The GUI was easy to use and generated intraoral molding devices within minutes. The presented design solution is an efficient technical refinement with good clinical results. The semi-automated plate generation with a feasible GUI is fast but allows individual adaptations. This promising technique might facilitate and foster the more widespread use of CAD/CAM-technology in intraoral molding therapy.
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