cleft lip and palate ( clp ) patients are going through an extensive treatment with 
 orthodontic and surgical correction of the position of teeth and hard and soft 
 tissues .
the aim of the primary surgery is to close the clefts of the lip and the 
 soft palate .
the aim of the secondary surgery is to close the cleft of the alveolus 
 by bone grafting .
surgery of the clefts induces formation of scar tissue , which 
 affects the soft tissue matrix that guides the development of the maxillary complex . 

the scar tissue as well as a reduced growth of the mid face often causes a maxillary 
 retrognatism , that adversely affects the chewing function , the ability to speak , the 
 facial aesthetics , social life   as well as psychological and general 
 wellbeing of the clp - patients . for that 
 reason ,
between 25 to 60% of the clp - patients need a surgical treatment of the 
 maxillary retrognatism
. this 
 surgical - orthodontic treatment is the last part of the rehabilitation of the 
 clp - patient , which has the objective to create a good dental occlusion and function , 
 more harmonic facial aesthetics and increase the quality of life .
since the 
 1970 's the standard treatment of clp - patients with a maxillary hypoplasia has 
 been a le fort i osteotomy with a bone graft .
treating extensive sagittal discrepancies maxillary surgery has to 
 be combined with mandibular set - back .
maxillary surgery is difficult in clp - patients 
 because of the scar tissue , a tendency to relapse , poor bone quality and quantity 
 and a reduced blood supply in the affected area .
these conditions are responsible for a typical relapse of 20 - 25% 
 . to compensate for this an overcorrection
is often made during the 
 surgical procedure , which can lead to an 
 unpredictable final result .
polley and figueroa   described the use of 
 distraction osteogenesis ( do ) as an alternative treatment of maxillary hypoplasia 
 using an external bone distraction device .
the principle of this treatment was to 
 induce formation of immature bone in the gap after a le fort i osteotomy by gradual 
 tensile strength separating the two segments .
studies of the treatment have shown a significantly reduced 
 tendency of relapse , favourable changes 
 of the soft tissue   and changes of the 
 velopharyngeal closure similar to that of conventional advancement .
the duration of the course of treatment is up to 16 weeks longer when choosing do . in 
 this period
the appliance penetrates the buccal mucosa in the sulcus and the patient 
 must take care of the daily activation and keep it clean .
the aim of this retrospective pilot study was to examine and compare the cleft lip 
 and palate patients ' satisfaction after treatment with either maxillary distraction 
 or traditional advancement of the maxilla after a le fort i osteotomy .
in the period 1996 - 2007 forty - two clp - patients with need for advancement of the 
 maxilla were surgically treated at the department of oral and maxillofacial surgery , 
 aarhus university hospital by either traditional advancement of the maxilla or 
 distraction osteogenesis . until 2000
the standard regime of treatment was a 
 traditional advancement of the maxillary complex after le fort i osteotomy . since 
 2000 maxillary distraction has provided an alternative in treatment of clp - patients 
 requiring a maxillary advancement of 10 mm or more .
consequently , the patients in 
 this study consisted of two groups of clp - patients with the need for 
 surgical - orthodontic correction of maxillary hypoplasia .
a criterion for both groups 
 was that the postsurgical orthodontics had to be finished if the patient was to be 
 included in the study .
conventional group ( conv ) included patients treated with 
 traditional advancement of the maxilla after a le fort i osteotomy in the period 
 1996 - 2007 .
the group do included patients treated with maxillary distraction table 1 . patients ' characteristics according to gender , type of cleft , type 
 of surgery performed , type of distractors used and age at surgery unsegmented le fort i osteotomy and internal distraction . unsegmented le fort i osteotomy and external distraction .
m = male ; f = female ; uclp = unilateral cleft lip and palate ; bclp = 
 bilateral cleft lip and palate ; cl .
fifteen patients met the inclusion criteria in the do group and ten patients in the 
 conv group .
the composition of the two groups according to gender , type of cleft , 
 type of distraction , type of distractors used , age at surgery and type of surgery 
 performed is presented in table 1 .
group do consisted of 10 males and 5 females with 
 a mean age at the time of surgery of 17.5 ( sd 2.3 ) years while group conv consisted 
 of 5 males and 5 females with a mean age at the time of surgery of 17.8 ( sd 2.6 ) 
 years . a quantitative method , a questionnaire ,
existing literature was reviewed and a list of 
 relevant subjects was made and operationalized in a questionnaire containing 13 
 questions about the patients ' perception of aesthetics and function .
the patients were asked to answer by making a mark on a vas - scale scaled 0 - 100 
 . the score 0 indicating the highest 
 level of satisfaction with functional parameters or facial aesthetics and the score 
 100 indicating the lowest level of satisfaction .
the end points of the scales were 
 unequivocal and easy to understand , for example no pain / intolerable pain ; very 
 satisfied / very unsatisfied ; no discomfort / worst imaginable discomfort .
the 
 accompanying letter contained information about the aim of the study and how to 
 answer .
the patients were asked to return the questionnaire by pre - paid mail after 
 two weeks .
the study was approved 
 by the central denmark region committees on biomedical research ethics .
all patients had presurgical orthodontic treatment and were treated surgically with a 
 high le fort i osteotomy . in the conv group
the treatment was a conventional 
 combined orthodontic - surgical treatment with model surgery and splint fabrication 
 for the maxillary position and completed with postsurgical orthodontics .
the 
 patients in the conv group had an average advancement of 6.98 mm ( range 5 - 11 mm ) . 

patients from the do group had the distraction device placed in pre - planned position 
 calculated from lateral cephalograms and adjusted on a three - dimensional print of 
 the skull based on a computed tomography ( ct ) or a cone beam ct ( cbct ) .
the appliances used for distraction were synthes internal distractor ( synthes , west 
 chester , pa , usa ) , kls martin internal distractor ( kls martin group , tuttlingen , 
 germany ) and rigid external device ( red ) kls martin ( kls martin group , tuttlingen , 
 germany ) for the external distraction procedures ( table 1 ) .
all the patients treated with distraction were registered for model surgery using the 
 same procedure as for the conventional treated patients using face bow registration , 
 wax bite and articulator mounting .
the patients had surgical splints fabricated and 
 in the cases of do the splint was used as a guide for using intermaxillary elastics 
 after the active distraction .
the maxilla was thereby manipulated into the final 
 planned position . in five of the do patients the palatal defect caused an unstable 
 intersegmental position .
the use of the splint was refrained from and intermaxillary 
 elastics were used to guide the segments into occlusion . during the surgical procedure the internal distraction devices were adapted to the 
 maxilla in the planned position .
the screw holes were marked and the devices were 
 removed in order to complete the le fort i osteotomy .
after ensuring mobility of the 
 maxilla the devices were fixed to the maxilla and tested for interference free 
 activation .
the mean latency period after device placement was 4.9 days ( range 4 - 7 days ) . 
 during the active phase of distraction
the appliances were activated on a daily 
 basis either by the patient or an assistant , usually a family member .
activation was 
 done twice a day with a rate of 0.5 mm , corresponding to 1.0 mm daily .
activation 
 went on until the planned position of the maxilla was achieved and intermaxillary 
 elastics were then used to adjust the final position .
the mean periodof active 
 distraction was 17.7 days ( range 13 - 28 days ) and the mean advancement of the 
 maxilla was 12 mm ( range 6 - 16 mm ) .
after an average consolidation period of 77.3 
 days ( range 35 - 213 days ) , the patients were readmitted and the devices removed in 
 general anaesthesia .
the treatment was a conventional combined orthodontic - surgical treatment with 
 model surgery and splint fabrication for the maxillary position and completed with 
 postsurgical orthodontics .
unpaired t - tests were performed to analyse intergroup differences regarding duration 
 of orthodontic treatment and vas - scores in spss 18.0 ( ibm , usa ) . statistical 
 significance was defined as p < 0.05 .
the duration of the orthodontic treatment was in average 10 months longer in the do 
 group than the conv group and this difference was significant ( p < 0.05 ) . neither 
 the age distribution nor the period of time between surgery and completion of the 
 questionnaire differed significantly ( p < 0.05 ) table 2 .
distribution of the patients ' groups according to gender , age at 
 surgery and period between surgery and completion of the 
 questionnaire after the primary surgery with insertion of the 
 distractors . after the surgical procedure .
unpaired t - test , states p < 0.05 between patients of do 
 and conv groups .
nineteen out of 25 patients returned the questionnaires and the total response ratio 
 was 76% .
results of the patients ' satisfaction on a continuous visual 
 analog - scale ( vas ) on a vas - scale scaled 0 - 100 with the score 0 indicating the 
 highest level of satisfaction with functional parameters or facial 
 aesthetics and the score 100 indicating the lowest level of 
 satisfaction .
both groups felt a great deal of satisfaction with their appearance both according to 
 themselves and the perceptions of relatives and other people 's reaction in 
 general .
both groups were satisfied with their general well being and felt few 
 restrictions or discomfort during social activities . according to functional 
 parameters the groups were alike .
both groups were minimally affected by pain and 
 sensory disturbances and reported a great deal of satisfaction with speech and 
 breathing .
the discomfort during eating and drinking and sleep were low as well in 
 both groups .
the greatest difference occurred in the parameter satisfaction with the 
 duration of the treatment course .
the do group scored higher on the vas - scale 
 according to less satisfaction with the duration than the conv group .
statistical 
 analyses revealed no significant differences ( p > 0.05 ) among the groups which 
 may be explained by the numbers of patients included in the study .
distraction osteogenesis has become a widely used treatment of maxillary hypoplasia 
 in clp - patients because of the reports of better stability and the possibility for 
 larger advancements .
however , it is a more complicated treatment because of the 
 period with active distraction , the obligate need for good cooperation and the long 
 consolidation phase with the patient still wearing the appliance .
the present study 
 is a pilot study and evaluates retrospectively patients ' satisfaction in two groups 
 of clp - patients treated for maxillary hypoplasia with either maxillary distraction 
 or conventional le fort i advancement .
the number of patients was limited and 
 especially the conv group was small and the number of patients responding was lower 
 than in the do group .
the results indicated a high level of satisfaction with the facial aesthetic at the 
 end of treatment in both the do and the conv group .
the parameters pain and sensory 
 disturbances did not differ a lot between the groups in this study .
it could be 
 hypothesized that more extensive osteotomies and preoperative advancements in conv 
 could induced more sensory disturbances and pain compared with a gradual movement 
 and distraction histogenesis of soft tissues when using do .
the groups had comparable scores according to the functional parameters eating and 
 drinking , sleep , speech and breathing .
do was significantly less satisfied with the 
 duration of the treatment than conv probably according to a longer duration of the 
 orthodontic treatment .
the influence of the period with the distractors mounted on 
 the level of satisfaction was not measured but it can be hypothesized that this 
 period is troublesome .
further studies of this period between mounting and removal 
 is needed as the prolonged total treatment time is a disadvantage and perhaps the 
 most important difference when choosing do instead of conventional treatment
. a 
 greater understanding of the cellular processes during the period of distraction and 
 the period of consolidation and possibility to accelerate the genesis and maturation 
 of bone by the use of pharmacological agents could reduce the duration of these 
 periods . by a reduction of the duration of these aforementioned periods
the 
 probable inconveniences could be reduced and possibly of a greater patients ' 
 satisfaction and lesser discomfort could be achieved . another way to reduce the 
 strain on the
do patients would be the continuous development of the distractors , 
 e.g. reduction in size , partly removable appliances , continuous activation etc . 
 .
patients ' satisfaction in association with distraction is a subject sparsely 
 examined in the existing literature .
no studies describes patients ' satisfaction 
 during internal distraction while only a single retrospective survey with a quite 
 small population has studied patients ' satisfaction during external distraction .
concluded that most of 
 the patients receiving red treatment had an increased satisfaction with facial 
 aesthetics after the treatment than before the treatment in spite of a great deal of 
 dissatisfaction with the facial aesthetics during the course of treatment .
a long term study of patients ' perception of function and satisfaction showed that 
 orthognathic surgery resulted in a subjective estimation of function , appearance , 
 health , and interpersonal relationships that was higher than that among pretreatment 
 and no - treatment control groups .
a newly 
 prospective study of patients receiving orthognathic surgery showed that perception 
 of function and general satisfaction significantly increased after orthognathic 
 surgery and that the parameters were positive correlated .
this study also showed a general high level of 
 satisfaction with appearance and functional parameters in clp - patients treated with 
 either do or conventional treatment .
the retrospective design of this survey and the two years between the operation and 
 the completion of the questionnaire diminished the reliability of the patients ' 
 answers .
the use of a questionnaires cause problems with the internal validity , 
 because the questionnaire is designed with a limited amount of topics , that might 
 not all be the most valid according to every single patient but representing a 
 selection bias . further use of this questionnaire necessitates a validation .
instead 
 a validated questionnaire , for instance the oral health impact profile or 
 orthognathic quality of life questionnaire can be used in further studies .
prospective surveys should 
 be based on a validated questionnaire and include the period between mounting and 
 removal of the distractors .
a comparative study of patients ' satisfaction during 
 three different courses of treatment , traditional advancement , external distraction 
 and internal distraction , could probably lead to a greater understanding of this 
 important subject .
1 . cleft lip and palate patients experience a high level of satisfaction with 
 functional parameters and aesthetics after surgical - orthodontic treatment of 
 maxillary hypoplasia .
patients treated with distraction osteogenesis were less satisfied with the 
 duration of their treatment than the conventional group .
no external 
 funding , apart from the support of the authors ' institution , was available for 
 this study .
 abstractobjectivesto compare cleft lip and palate patients ' satisfaction with aesthetics and 
 functional parameters after conventional advancement of the maxilla or by 
 the use of distraction osteogenesis.material and methodscase series observational study . 
 group of distraction osteogenesis ( do ) 
 consisted of 15 patients treated with distraction osteogenesis while group 
 conventional ( conv ) included 10 patients treated with traditional 
 advancement of the maxilla . 
 patients were asked to fill out a questionnaire 
 about their subjective evaluation of satisfaction with facial aesthetics and 
 functional parameters on a continuous visual analog - scale ( vas ) when the 
 treatment was finished.resultsthe total response rate was 76% . 
 preoperatively the two groups did not differ 
 significantly according to group characteristics . at follow - up 
 both groups 
 were satisfied with aesthetics and functional parameters . 
 the do group was 
 less satisfied with the duration of the treatment than the conv group . 
 there 
 were no statistically significant differences among the groups regarding 
 functional parameters or facial aesthetics.conclusionscleft lip and palate patients experienced a high level of satisfaction with 
 functional parameters and aesthetics as a result of surgical maxillary 
 advancement . 
 the patients treated with distraction osteogenesis were less 
 satisfied with the duration of the treatment . 
 further studies are 
 needed . 
INTRODUCTION
MATERIAL AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
ACKNOWLEDGEMENTS AND DISCLOSURE STATEMENTS