Super-Passive Alveolar Correcting Equipment (SPACE): a novel presurgical cleft device with 5-year outcomes following one-stage repair.

In patients with unilateral cleft lip, alveolus, and palate (U-CLAP), wide clefts negatively affect facial aesthetics, alveolar alignment, and speech. Although various presurgical orthopedic devices have been used, none reliably achieve substantial cleft narrowing. This study introduces the Super-Passive Alveolar Correcting Equipment (SPACE), a molar-supported passive plate that significantly reduces cleft width, narrowing the mean alveolar gap to 1.87 mm before surgery (n = 83). SPACE enabled a one-stage repair - lip repair, gingivoperiosteoplasty, and palatoplasty - performed at approximately 6 months of age. All patients underwent the one-stage procedure, with no oronasal fistulas observed. Among them, 56 complete U-CLAP patients were assessed using six linear measurements from dental casts obtained at the initial visit, before surgery, and at 1 year. Five-year outcomes included evaluations of maxillofacial growth (via lateral cephalometry), need for secondary alveolar bone grafting (SBG), and speech development. At age 5, cephalometric values were comparable between the SPACE one-stage (SOG) and the conventional Hotz multistage groups (HMG), except for U1-NF. The SBG avoidance rate with the SOG was 38.6 %. Malarticulation occurred in 14.6 % of the SOG patients, versus 42.2 % for the HMG. SPACE provides reliable presurgical cleft narrowing and facilitates a simplified one-stage protocol with favorable mid-term outcomes.