Objective:To investigate the effects of asymmetric trans-sutural distraction osteogenesis for severe midfacial hypoplasia in growing patients with unilateral cleft lip and palate.Methods:All the growing patients with unilateral cleft lip and palate combining severe midfacial hypoplasia treated with asymmetric trans-sutural distraction osteogenesis from January 2011 to December 2020 in the Plastic Surgery Hospital, Chinese Academy of Medical Sciences were analyzed retrospectively. The distraction system consisted of the bone-borne traction hooks, nickel-titanium shape memory alloy spring and rigid external distractor. Asymmtric distraction could be achieved by exerting different traction force to bilateral maxilla. The technique for relapse prevention included moderate overcorrection, prompt orthodontic treatment and face mask therapy. The changes of midfacial symmetry between the cleft and non-cleft side were analyzed by comparing the distance of subspinale A-point(A), intersection of lateral border of piriform aperture and plane parallel to midsagittal reference plane(LPA), most inferior point on nasomaxillary suture(INM) and most inferior point on profile of pterygomaxillary suture(PTM) to coronal reference plane between preoperative and postoperative, and the asymmetric ratio of LPA, INM and PTM were calculated.Results:A total of 38 patients, (34 males and 4 females, aged from 8-15 years) were included. All of the patients completed the distraction and achieved a satisfied improvement in the midface convexity and overjet. The postoperative 1-3 years follow-up showed the midface protrusion and occlusal overcoverage after distraction caused by overcorrection tended to become harmonious in the following 6 to 12 months, and 3 patients with no face mask therapy done had relapse on maxilla in various degrees after 3 years follow-up. The measurement findings of 25 patients showed the average advancement of A point was (12.67±4.62) mm(range, 6.21-23.28 mm). The distances of INM, LPA and PTM to CR plane on the cleft side were significantly less than that on the non-cleft side before the distraction( P<0.05). However, after the distraction, these distance differences of INM and PTM between the cleft and non-cleft side were eliminated ( P>0.05). The distance difference of bilateral LPA was reduced, but still significant less on the cleft side( P<0.05). Compared before and after distraction, the asymmetric rate of INM, LPA and PTM was significantly decreased( P<0.05). Conclusions:Asymmetric trans-sutural distraction osteogenesis offers an effective method for the early treatment of severe midfacial hypoplasia in growing patients with unilateral cleft lip and palate, and restores the midfacial symmetry.

Objective:To systematically describe the characteristics and trends of clinical studies on aesthetic and plastic devices from 2016 to 2020 in China.Methods:Clinical studies on aesthetic and plastic devices conducted in China from 2016 to 2020 were identified through ClinicalTrials.gov and the Chinese Clinical Trial Registry using predetermined search strings. Data on indications, medical device, sponsor type, and study design were collected and analyzed.Results:From 2016 to 2020, 118 registered clinical studies were identified and analyzed, among which 100 trials (84.7%) were initiated by medical institutions and the remaining were initiated by medical device enterprises. The number of studies increased from 12 to 42 from 2016 to 2020 with an average annual growth rate of 39.6%. For indication types, there are 90(76.3%) studies on skin defects, followed by 21(17.8%) on maxillofacial defects, 5(4.2%) on hair defects and 2(1.7%) on breast defects. The top four indications were scars, acne, nasolabial folds, and port-wine stains. For device types, photoelectric devices were involved in 73(61.9%) studies, followed by surgical devices [20(16.9%)] and injection devices [19(16.1%)]. Laser devices were the research focus among all photoelectric device categories. There were 11 clinical studies on scar treatment using laser treatment equipment, of which 6 trials applied parallel controlled study design, and the remaining trials applied self-controlled design. The sample size of these 11 trials ranged from 15 to 110.Conclusions:The number of registered clinical studies on aesthetic and plastic devices kept growing in the last few years. Skin related indications and photoelectric devices have become the hot spot in the field.

Objective:To investigate the effects of asymmetric trans-sutural distraction osteogenesis for severe midfacial hypoplasia in growing patients with unilateral cleft lip and palate.Methods:All the growing patients with unilateral cleft lip and palate combining severe midfacial hypoplasia treated with asymmetric trans-sutural distraction osteogenesis from January 2011 to December 2020 in the Plastic Surgery Hospital, Chinese Academy of Medical Sciences were analyzed retrospectively. The distraction system consisted of the bone-borne traction hooks, nickel-titanium shape memory alloy spring and rigid external distractor. Asymmtric distraction could be achieved by exerting different traction force to bilateral maxilla. The technique for relapse prevention included moderate overcorrection, prompt orthodontic treatment and face mask therapy. The changes of midfacial symmetry between the cleft and non-cleft side were analyzed by comparing the distance of subspinale A-point(A), intersection of lateral border of piriform aperture and plane parallel to midsagittal reference plane(LPA), most inferior point on nasomaxillary suture(INM) and most inferior point on profile of pterygomaxillary suture(PTM) to coronal reference plane between preoperative and postoperative, and the asymmetric ratio of LPA, INM and PTM were calculated.Results:A total of 38 patients, (34 males and 4 females, aged from 8-15 years) were included. All of the patients completed the distraction and achieved a satisfied improvement in the midface convexity and overjet. The postoperative 1-3 years follow-up showed the midface protrusion and occlusal overcoverage after distraction caused by overcorrection tended to become harmonious in the following 6 to 12 months, and 3 patients with no face mask therapy done had relapse on maxilla in various degrees after 3 years follow-up. The measurement findings of 25 patients showed the average advancement of A point was (12.67±4.62) mm(range, 6.21-23.28 mm). The distances of INM, LPA and PTM to CR plane on the cleft side were significantly less than that on the non-cleft side before the distraction( P<0.05). However, after the distraction, these distance differences of INM and PTM between the cleft and non-cleft side were eliminated ( P>0.05). The distance difference of bilateral LPA was reduced, but still significant less on the cleft side( P<0.05). Compared before and after distraction, the asymmetric rate of INM, LPA and PTM was significantly decreased( P<0.05). Conclusions:Asymmetric trans-sutural distraction osteogenesis offers an effective method for the early treatment of severe midfacial hypoplasia in growing patients with unilateral cleft lip and palate, and restores the midfacial symmetry.

Objective:To systematically describe the characteristics and trends of clinical studies on aesthetic and plastic devices from 2016 to 2020 in China.Methods:Clinical studies on aesthetic and plastic devices conducted in China from 2016 to 2020 were identified through ClinicalTrials.gov and the Chinese Clinical Trial Registry using predetermined search strings. Data on indications, medical device, sponsor type, and study design were collected and analyzed.Results:From 2016 to 2020, 118 registered clinical studies were identified and analyzed, among which 100 trials (84.7%) were initiated by medical institutions and the remaining were initiated by medical device enterprises. The number of studies increased from 12 to 42 from 2016 to 2020 with an average annual growth rate of 39.6%. For indication types, there are 90(76.3%) studies on skin defects, followed by 21(17.8%) on maxillofacial defects, 5(4.2%) on hair defects and 2(1.7%) on breast defects. The top four indications were scars, acne, nasolabial folds, and port-wine stains. For device types, photoelectric devices were involved in 73(61.9%) studies, followed by surgical devices [20(16.9%)] and injection devices [19(16.1%)]. Laser devices were the research focus among all photoelectric device categories. There were 11 clinical studies on scar treatment using laser treatment equipment, of which 6 trials applied parallel controlled study design, and the remaining trials applied self-controlled design. The sample size of these 11 trials ranged from 15 to 110.Conclusions:The number of registered clinical studies on aesthetic and plastic devices kept growing in the last few years. Skin related indications and photoelectric devices have become the hot spot in the field.

Maxillary hypoplasia frequently develops in patients with cleft lip and/or palate(CLP). The individuals presented with Class Ⅲ malocclusions and a retruded mid-face usually need orthognathic surgery to correct jaw deformity.Based on ourselves clinical experience and research in the past ten years, combining with literature reports, the authors classified the maxillary retrusion with CLP and propose a strategy for orthognathic surgeries.

Objective:To present the clinical results and potential complications of modified maxillary distraction osteogenesis in the treatment of moderate to severe maxillary hypoplasia for patients with cleft lip and palate.Methods:All the cases were treated with a modified distraction osteogenesis in the Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from July 2017 to December 2019. A rigid external distraction(RED) with intranasal bone-borne traction hooks was performed after the Le Fort Ⅰ osteotomy and a maxillary internal rigid fixation was done immediately after 3-4 weeks of RED device distraction. Paired-samples t-test was used to analyze the three-dimensional reconstruction and measurements of the patient’s preoperative (T0) and immediate completion of traction (T1) cranial CT maxillofacial bony structures. Results:Fifteen patients (12 males and 3 females, ranging from 14 to 25 years in age) with moderate to severe maxillary hypoplasia were analyzed retrospectively. There were significant differences ( P<0.05) in all measures of maxillary and mandibular morphology at the completion of distraction compared to preoperatively. The mean advancement of A point (subspinale) was (10.69±9.01) mm, and the mean increase in ANB (subspinale-nasion-supramental) was (13.53±7.14)°. The average increase of alveolar plane and mandibular plane was (3.97±5.87)° and (4.65±3.67)° separately. The average growth of anterior facial height was (5.63±4.41) mm. The maxilla moved forward and downward, increasing the midface prominence and improving the facial contour. The traction process had an effect on the position of the mandible, with 5 in 15 patients experiencing moderate to severe decreased mouth opening, and the mouth opening limitation was relieved by mouth opening training after fixation at the end of distraction. One patient experienced temporomandibular joint (TMJ) dislocation, which was relieved by manual repositioning and mouth opening training after maxillary fixation and sagittal split ramus osteotomy. Conclusions:Modified maxillary distraction osteogenesis can effectively advance the maxilla, allowing clockwise rotation of mandible, improving facial contour, and significantly shortening the traction time. Limited mouth opening and TMJ dislocation may occur during traction.

Maxillary hypoplasia frequently develops in patients with cleft lip and/or palate(CLP). The individuals presented with Class Ⅲ malocclusions and a retruded mid-face usually need orthognathic surgery to correct jaw deformity.Based on ourselves clinical experience and research in the past ten years, combining with literature reports, the authors classified the maxillary retrusion with CLP and propose a strategy for orthognathic surgeries.

Objective:To present the clinical results and potential complications of modified maxillary distraction osteogenesis in the treatment of moderate to severe maxillary hypoplasia for patients with cleft lip and palate.Methods:All the cases were treated with a modified distraction osteogenesis in the Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from July 2017 to December 2019. A rigid external distraction(RED) with intranasal bone-borne traction hooks was performed after the Le Fort Ⅰ osteotomy and a maxillary internal rigid fixation was done immediately after 3-4 weeks of RED device distraction. Paired-samples t-test was used to analyze the three-dimensional reconstruction and measurements of the patient’s preoperative (T0) and immediate completion of traction (T1) cranial CT maxillofacial bony structures. Results:Fifteen patients (12 males and 3 females, ranging from 14 to 25 years in age) with moderate to severe maxillary hypoplasia were analyzed retrospectively. There were significant differences ( P<0.05) in all measures of maxillary and mandibular morphology at the completion of distraction compared to preoperatively. The mean advancement of A point (subspinale) was (10.69±9.01) mm, and the mean increase in ANB (subspinale-nasion-supramental) was (13.53±7.14)°. The average increase of alveolar plane and mandibular plane was (3.97±5.87)° and (4.65±3.67)° separately. The average growth of anterior facial height was (5.63±4.41) mm. The maxilla moved forward and downward, increasing the midface prominence and improving the facial contour. The traction process had an effect on the position of the mandible, with 5 in 15 patients experiencing moderate to severe decreased mouth opening, and the mouth opening limitation was relieved by mouth opening training after fixation at the end of distraction. One patient experienced temporomandibular joint (TMJ) dislocation, which was relieved by manual repositioning and mouth opening training after maxillary fixation and sagittal split ramus osteotomy. Conclusions:Modified maxillary distraction osteogenesis can effectively advance the maxilla, allowing clockwise rotation of mandible, improving facial contour, and significantly shortening the traction time. Limited mouth opening and TMJ dislocation may occur during traction.

Objective: This study is to repair nostril sill deformity in the cleft lip patients by reconstructing the first auxiliary muscle tension line group and to assess the therapeutic outcome. Methods: 437 cleft lip patients with nostril sill deformity underwent the surgery from January 1, 2012 to November 1, 2016.They were treated using the technique of first auxiliary muscle tension line group reconstruction to repair the deformity. Aesthetic correction evaluations were rated by the GAIS. Random digit was used to randomly select 24 patients during the follow-up for three-dimensional measurement and analysis. The preoperative and postoperative symmetry of the nostril sills were evaluated by paired t test. Results: Mucosal ischemia or wound infection occurred in 11 cases, left obvious scar on the nostril floor. Surgical incisions of the other patients were primary healing. After 6 months to 3 years follow up, GAIS questionnaires of 378 patients demonstrated that 84% patients reported great or moderate improvement of nostril sills. Three-dimensional measurements of 24 patients suggested that there were no significant differences of the nostril sill and the nasal ala between the cleft side and the normal side. Conclusions First auxiliary tension line group reconstruction, which is to restore biomechanical balance rather than merely increase muscle volume, is an effective method of nostril sill repair in the cleft lip patients. Post-operatively, the patients achieved a stable and natural nostril sill, a middle columella, as well as a narrowed nasal ala.

OBJECTIVETo classify the patients with cleft lip and palate who need orthognathic surgery and to propose the corresponding operations.

METHODSFrom January 2005 to May 2015, 121 patients with cleft lip and palate diagnosed as maxillary retrusion were treated by orthognathic surgery. Inclusion criteriar: (1) male aged over 16, female aged over 14; (2) diagnosed as non-syndromic cleft lip and palate without systemic disease and other genetic diseases; (3) without previous orthodontic and orthognathic treatment; (4) having no other craniofacial malformation. Maxillary features and repaired types were recorded.

RESULTS93 patients were included and divided into two categories depended on the dental crowding. Class I: the teeth quantity and bone quantity is coordinated, space analysis ≤ 4 mm (mild dental crowding). The forward distance of maxillary less than 6 mm was defined as Class I a (36 cases) more than 6 mm as Class I b (28 cases). Class II: the teeth quantity and bone quantity is not coordinated, space analysis > 4 mm ( moderate or severe dental crowding). After the simulation of distraction osteogenesis, the anterior crossbite was corrected defined as Class II a (23 cases), not corrected defined as Class II b (6 cases). Class I a were corrected by conventional orthognathic surgery. While Class I b were corrected by Le Fort I maxillary advancement using distraction osteogenesis. Class II a were repaired just by anterior maxillary distraction. While Class II b need to combine conventional orthognathic surgery with anterior maxillary distraction. All the patients were satisfied with the treatment effect.

CONCLUSIONSThe patients of cleft lip and palate with maxillary retrusion who need orthognathic surgery can be classified as the method mentioned above, and then choose the appropriate operations.

Adolescent ; Adult ; Cleft Lip ; complications ; Cleft Palate ; complications ; Female ; Humans ; Male ; Maxilla ; Osteogenesis, Distraction ; Osteotomy, Le Fort ; Retrognathia ; classification ; surgery