***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    ***EXAMPLES*** 
    Input: PURPOSE To compare the early psychological changes of cleft lip and palate ( CLP ) and noncleft patients after maxillofacial corrective surgery , including maxillary distraction osteogenesis and conventional orthognathic surgery .  MATERIAL S AND METHODS Nine CLP patients were compared with a group of 9 non-CLP patients having similar dentofacial deformities in a prospect i ve longitudinal cohort study . Five of the CLP patients underwent maxillary distraction osteogenesis and 4 underwent conventional orthognathic surgery . A control group of 9 noncleft patients received conventional orthognathic surgery . All patients completed a set of question naires to enable their psychological profile to be assessed . The data were collected immediately before surgery ( T1 ) , and at 3 weeks ( T2 ) and 12 weeks ( T3 ) after surgery . RESULTS The CLP patients treated with distraction osteogenesis were happier , but had a higher level of social anxiety and distress than the CLP patients receiving conventional orthognathic surgery . On the other h and , the CLP patients overall were happier , with lower social anxiety and distress , than the noncleft control group . The CLP patients showed a higher level of parental self-esteem than the noncleft patients . CONCLUSION This preliminary study shows that CLP patients were generally happier , and had a higher level of parental support , than normal patients suffering from dentofacial deformities . Maxillary distraction osteogenesis seemed to induce a higher level of anxiety and distress in CLP patients than conventional orthognathic surgery in both cleft and noncleft patients OBJECTIVE The objective of this study was to compare the long-term stability of distraction osteogenesis ( DO ) and conventional orthognathic surgery ( CO ) in patients with cleft lip and palate ( CLP ) . STUDY DESIGN CLP patients requiring maxillary advancement of 4 to 10 mm were r and omized and assigned to either CO or DO . In the CO group , the maxilla was fully mobilized to the preplanned position and fixed using titanium miniplates . In the DO group , the maxilla was mobilized to a limited extent and distractors were fixed on each side of the maxilla . Serial lateral cephalographs were taken for the assessment of stability at different postoperative periods up to 5 years . RESULTS In the CO group , the maxilla relapsed backward and upward , whereas in the DO group , it advanced more forward and downward over 5 years . CONCLUSIONS Distraction of the cleft maxilla can achieve better long-term skeletal stability in maintaining its advanced position than CO Surgery and other invasive therapies are complex interventions , the assessment of which is challenged by factors that depend on operator , team , and setting , such as learning curves , quality variations , and perception of equipoise . We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process . We also encourage the widespread use of prospect i ve data bases and registries . Reports of new techniques should be registered as a professional duty , anonymously if necessary when outcomes are adverse . Case series studies should be replaced by prospect i ve development studies for early technical modifications and by prospect i ve research data bases for later pre-trial evaluation . Protocol s for these studies should be registered publicly . Statistical process control techniques can be useful in both early and late assessment . R and omised trials should be used whenever possible to investigate efficacy , but adequate pre-trial data are essential to allow power calculations , clarify the definition and indications of the intervention , and develop quality measures . Difficulties in doing r and omised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems . Alternative prospect i ve design s , such as interrupted time series studies , should be used when r and omised trials are not feasible . Established procedures should be monitored with prospect i ve data bases to analyse outcome variations and to identify late and rare events . Achievement of improved design , conduct , and reporting of surgical research will need concerted action by editors , funders of health care and research , regulatory bodies , and professional societies OBJECTIVE The objective of this study was to compare the psychological changes of patients with cleft lip and palate ( CLP ) undergoing maxillary Le Fort I advancement by distraction osteogenesis ( DO ) and conventional orthognathic surgery ( CO ) .  STUDY DESIGN Prospect i ve r and omized controlled study . Participants completed a set of question naires to measure their psychological states preoperatively and postoperatively . RESULT When compared with CO , CLP patients treated with DO had lower social self-esteem and higher social avoidance and distress levels during the first 3 postoperative months . Their self-esteem , social avoidance , and distress levels improved after the distractors were removed . Both CO and DO patients had similar levels of self-esteem , social avoidance , and distress levels 2 years postoperatively . The CLP patients treated with DO were more satisfied with their lives after 2 years . CONCLUSIONS DO may induce short-term distress to patients up to 3 months but CLP patients who received DO were more satisfied with their lives in the long term This clinical r and omized controlled trial was performed to compare the effects of distraction osteogenesis ( DO ) and conventional orthognathic surgery ( CO ) on velopharyngeal function and speech outcomes in cleft lip and palate ( CLP ) patients . Twenty-one CLP patients who required maxillary advancement ranging from 4 to 10 mm were recruited and r and omly assigned to either CO or DO . Evaluation of resonance and nasal emission , nasoendoscopic velopharyngeal assessment and nasometry were performed preoperatively and at a minimum of two postoperative times : 3 - 8 months ( mean 4 months ) and 12 - 29 months ( mean 17 months ) . Results showed no significant differences in speech and velopharyngeal function changes between the two groups . No correlation was found between the amount of advancement and the outcome measures . It was concluded that DO has no advantage over CO for the purpose of preventing velopharyngeal incompetence and speech disturbance in moderate cleft maxillary advancement Background : This is the first r and omized controlled study aim ing to compare the postoperative clinical morbidities in cleft lip and palate patients treated with  distraction osteogenesis versus conventional orthognathic surgery . Methods : Twenty-nine cleft lip and palate patients with moderate maxillary hypoplasia requiring a maxillary Le Fort I advancement of 4 to 10 mm were r and omized into two groups for either internal maxillary distractors or immediate fragment transposition using miniplates and screw fixation . Clinical morbidities were recorded using st and ardized question naires . Skeletal and dental relapses were assessed using lateral cephalometric l and marks . Results : In the distraction group , two of 15 patients developed infection around the distractors and one patient had an occlusal relapse . Among the 14 patients who received conventional orthognathic surgery  , the complications included intraoperative hemorrhage ( n = 1 ) , plate exposure leading to sinusitis ( n = 1 ) , and occlusal relapse ( n = 1 ) . In the skeletal relapses of the osteotomy group , a statistically significant vertical relapse of the A point was noted during the second to twelfth weeks when compared with the distraction group . A statistically significant horizontal relapse of the A and P points during the eighth to twelfth weeks was noted when the osteotomy group was compared with the distraction group . Conclusions : There were no major differences in the clinical morbidities between the osteotomy and distraction groups . Distraction provided better skeletal stability , whereas there was a significant amount of skeletal relapse in the first 12 weeks after conventional cleft maxillary osteotomy The teratogenic potential of oral and topical corticosteroid treatment during pregnancy was evaluated in the population -based large data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities , 1980 - 1994 .  Corticosteroid tablet pregnancy exposure was 1.55 % among 20,830 malformed cases and 1.41 % among 35,727 healthy control births ( P = 0.2 ) . Corticosteroid ointment pregnancy exposure was 0.35 % among malformed and 0.33 % among control births ( P = 0.7 ) . The absolute risk of oral and ointment corticosteroid treatment  was low in pregnancy and particularly in the second and third months of gestation , i.e. , in the critical period for major congenital abnormalities . The adjusted odds ratio and the analysis of case-control pairs did not show any association between the rate of different congenital abnormalities and the corticosteroid treatment in the second and third months of gestation . Thus , treatments with corticosteroids in pregnancy do not appear to noticeably increase the risk of congenital abnormalities in humans PURPOSE Conventional maxillary distraction osteogenesis and anterior maxillary segmental distraction were applied in the treatment of severe maxillary hypoplasia secondary to cleft clip and palate . The aim of the present study was to compare the difference between these 2 osteotomy modalities used for rigid external distraction . PATIENTS AND METHODS Ten patients with severe maxillary hypoplasia secondary to CLP were enrolled in our study . They were r and omly divided into 2 groups . Conventional maxillary distraction osteogenesis was performed in 5 patients and anterior maxillary segmental distraction in 5 patients . The preoperative and postoperative lateral cephalograms were compared , and cephalometric analysis was performed . The independent sample t test was used to evaluate the differences between the 2 groups . RESULTS All patients healed uneventfully , and the maxillae moved forward satisfactorily . The sella-nasion-point A angles , nasion-point A-Frankfort horizontal plane angles , overjets , and 0-meridian to subnasale distances had increased significantly after distraction osteogenesis . Significant differences were found in the changes in palatal length between the 2 groups ( P < .05 ) . A mean increase of 7.50 mm in palatal length was found in the anterior maxillary segmental distraction group . No significant difference in the changes in palatopharyngeal depth or soft palatal length was found . CONCLUSIONS With the ability of increasing the palatal and arch length , avoiding changes in palatopharyngeal depth , and preserving palatopharyngeal closure function , anterior maxillary segmental distraction has great value in the treatment of maxillary hypoplasia secondary to CLP . It is a promising and valuable technique in this potentially complicated procedure Objective : To compare speech outcome and velopharyngeal ( VP ) status of subjects with repaired cleft palate who underwent either conventional Le Fort I osteotomy or maxillary distraction osteogenesis to correct maxillary hypoplasia . Design : Prospect i ve r and omized study with blind assessment of speech outcome and VP status . Subjects : Twenty-two subjects were r and omized into conventional Le Fort I osteotomy and Le Fort I distraction groups . All were native Chinese ( Cantonese ) speakers . Method : Perceptual judgment of resonance and nasal emission , study of VP structures by  nasoendoscopy  , and instrumental measurement  by  nasometry .  Assessment s were performed preoperatively and at 3 months postoperatively . Main Outcome Measures : Assessment of VP closure , perceptual rating of hypernasality and nasal emission , nasalance , and amount of maxillary advancement . Results : There was no statistical difference in any of the outcome measures between the 10 subjects with conventional Le Fort I osteotomy and the 12 subjects with maxillary distraction : hypernasality ( chi-square = 3.850 , p = 0.221 ) , nasal emission ( chi-square = 0.687 , p = 0.774 ) , VP gap size ( chi-square = 1.527 , p = 0.635 , and nasalance ( t = −0.145 , p = 0.886 ) . There was no correlation between amount of maxillary advancement and any of the outcome measures ( p = .05 for all ) . Changes in VP gap size and resonance are described . Conclusion : Results need to be interpreted with caution because of the small sample size and early follow-up . However , this study utilized an assessment protocol involving a variety of outcome measures and careful consideration of reliability factors , which can be a model for further and follow-up studies PURPOSE The purpose of this study was to investigate the changes in and stability of the maxilla and soft tissue profile achieved after the application of distraction osteogenesis ( DO ) by use of rigid external distraction ( RED ) with a retention plate system in unilateral cleft lip and palate ( UCLP ) adult patients . We compared 2 treatment methods in the management of maxillary hypoplasia : Le Fort I osteotomy and DO . MATERIAL S AND METHODS Six UCLP adult patients who underwent treatment with the RED retention plate system were examined ( DO group ) .  Changes in the positions of soft and hard tissue l and marks were calculated from lateral cephalograms taken before distraction , at the removal of the halo , and 1 year after surgery and were compared with those in 7 other UCLP patients who underwent Le Fort I osteotomy ( LF1 group ) . RESULTS The mean maxillary advancement was significantly larger in the DO group than in the LF1 group after distraction . During the follow-up period , the relapse rate of the maxilla was significantly smaller in the DO group . An undesirable labial inclination of the upper incisors was found in the LF1 group , which may have been due to relapse . The DO group tended to have a higher soft tissue-to-hard tissue anterior movement ratio from the time of distraction to follow-up . CONCLUSIONS The RED retention plate system improved the midfacial profile by advancement of soft and hard tissue and minimized the risk of injury to the upper lip . Using the RED system with retention plates prevented the undesirable labial inclination of upper incisors that was found in the LF 
    Output:
    
Both interventions produced notable hard and soft tissue improvements .
Horizontal relapse of the maxilla was significantly less in the distraction osteogenesis group five years after surgery .