Rigid external distraction– down-fracture or not, can we modify the approach?

Distraction osteogenesis (DO) has been proposed as treatment to many craniofacial syndromes including cleft lip and palate (CLP) complicated by skeletal discrepancies. Rigid external distraction (RED) in the recent years has been advocated to treat severe form of skeletal discrepancies that cannot be corrected with conventional orthognathic surgery. The purpose of this study was to compare new approaches and surgical outcomes in treating patients with cleft lip and palate who underwent rigid external distraction. This study was conducted at the King Hussein Medical Center, Hashemite Kingdom of Jordan, from Jan 2024 to Jan 2025, and was approved by the Research & Ethics Committee of the Institute. The inclusion criteria included patients who had a history of cleft lip and palate, were diagnosed with severe hypoplastic maxilla, had reverse overjet greater than 10 mm, and had a class III skeletal discrepancy. We used the RED II device fabricated by KLS Martin (Tuttlingen, Germany). Two groups were included in this study. Group 1 accommodated patients who underwent the conventional surgical procedure with placement of the RED device. Group 2 included patients who underwent a new surgical method with RED placement. The new method involved a Le Fort I osteotomy with an additional down fracture and fixation with a double-Y miniplate after the consolidation period, whereas the conventional method did not involve a downward fracture. All patients/guardians were given the options, complications, and drawbacks of each surgery. Verbal and written consent were obtained for surgical and research purposes. Five patients were involved in this study, two of whom underwent the conventional method, as they preferred the conventional method, and three agreed to undergo the new approach and, finally, placement of the RED device. Pain was evaluated with the visual analog scale (VAS). Esthetics and compliance were evaluated starting on postoperative Day 7. Females had a lower pain threshold, whereas male participants had a drastic drop in pain perception. Female patients had trouble tolerating the device esthetically, with gradual acceptance of its appearance. Our study demonstrated better tolerance to the newer approach. Although the newer method involves an additional surgical stabilization procedure, which involves the application of two titanium mini plates 2.0 mm in length, one on each side at the anterior aspect of the maxilla upon removal of the device, this new method has shown acceptance and tolerance by patients and should be further tested to aid in patient outcomes. This method has shown better pain tolerance, less time of activation, and a permanent period of the consolidation phase.