Fahad S. Al Qooz , Mohammad S. Al Olaimat , Dina N. Smeirat , Luma A. Al Najada , Zaid R. Alzoubi , Saleh E. Al Aazmi , Ali S. Al Murdif
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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.</div></div><div><h3>Purpose</h3><div>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.</div></div><div><h3>Patients & methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":100051,"journal":{"name":"Advances in Oral and Maxillofacial Surgery","volume":"20 ","pages":"Article 100589"},"PeriodicalIF":0.0000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Rigid external distraction– down-fracture or not, can we modify the approach?\",\"authors\":\"Fahad S. Al Qooz , Mohammad S. Al Olaimat , Dina N. Smeirat , Luma A. Al Najada , Zaid R. Alzoubi , Saleh E. Al Aazmi , Ali S. Al Murdif\",\"doi\":\"10.1016/j.adoms.2025.100589\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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.</div></div><div><h3>Purpose</h3><div>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.</div></div><div><h3>Patients & methods</h3><div>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. 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引用次数: 0
摘要
牵张成骨术(DO)已被提出用于治疗许多颅面综合征,包括唇腭裂(CLP)并发骨骼差异。近年来,刚性外牵引(RED)被提倡用于治疗传统正颌手术无法纠正的严重骨骼差异。目的本研究的目的是比较硬外牵引治疗唇腭裂的新方法和手术效果。患者和方法本研究于2024年1月至2025年1月在约旦哈希姆王国侯赛因国王医学中心进行,并获得该研究所研究和伦理委员会的批准。纳入标准包括有唇腭裂病史,诊断为严重上颌骨发育不全,反向覆盖大于10 mm,骨骼差异为III级的患者。我们使用了KLS Martin (Tuttlingen, Germany)制造的RED II装置。本研究分为两组。第1组接受常规外科手术并放置RED装置的患者。第2组包括采用新手术方法放置RED的患者。新方法包括Le Fort I型截骨术,并在巩固期后进行额外的向下骨折和双y型微型钢板固定,而传统方法不涉及向下骨折。所有患者/监护人被告知每种手术的选择、并发症和缺点。获得手术和研究目的的口头和书面同意。结果5名患者参与了这项研究,其中2名患者接受了传统方法,因为他们更喜欢传统方法,另外3名患者同意接受新方法,最后放置RED装置。采用视觉模拟评分法(VAS)评估疼痛。从术后第7天开始评估美观性和依从性。女性的疼痛阈值较低,而男性参与者的疼痛感知则急剧下降。女性患者在审美上难以忍受这种装置,逐渐接受了它的外观。结论我们的研究显示对新入路的耐受性更好。虽然新方法涉及额外的手术稳定程序,包括在取出装置时在上颌骨的前侧面应用两个长度为2.0 mm的迷你钛板,每侧一个,但这种新方法已经显示出患者的接受和耐受性,应该进一步测试以帮助患者预后。该方法显示出更好的疼痛耐受性,更短的激活时间和永久性的巩固期。
Rigid external distraction– down-fracture or not, can we modify the approach?
Background
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.
Purpose
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.
Patients & methods
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.
Results
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.
Conclusion
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.