Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: maxillary growth at eight years of age

2019 ◽  
Author(s):  
Annelise Küseler ◽  
Kirsten Mølsted ◽  
Agneta Marcusson ◽  
Arja Heliövaara ◽  
Agneta Karsten ◽  
...  
Keyword(s):  
Soft Palate ◽  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Common Method ◽  
Controlled Clinical Trial ◽  
Surgical Method ◽  
Lateral Cephalograms ◽  
The Common ◽  
Maxillary Growth

Summary Objectives To assess differences in craniofacial growth at 8 years of age according to the different protocols for primary cleft surgery in the Scandcleft project. Design and setting Prospective, randomized, controlled clinical trial (RCT) involving 10 centres, including non-syndromic Caucasians with unilateral cleft lip and palate (UCLP). In Trial 1, a common surgical method (1a) with soft palate closure at 3–4 months of age and hard palate closure at 12 months of age was tested against similar surgery but with hard palate repair at 36 months (delayed hard palate closure) (1b). In Trial 2, the common method (2a) was tested against simultaneous closure of both hard and soft palate at 1 year (2c). In Trial 3, the common method (3a) was tested against hard palate closure together with lip closure at 3 months of age and soft palate closure at 1 year of age (3d). Participants were randomly allocated by use of a dice. Operator blinding was not possible but all raters of all outcomes were blinded. Subjects and methods The total number of participating patients at 8 years of age was 429. Lateral cephalograms (n = 408) were analysed. The cephalometric angles SNA and ANB were chosen for assessing maxillary growth for this part of the presentation. Results Within each trial (Trial 1a/1b, Trial 2a/2c, and Trial 3a/3d), there was no difference in cephalometric values between the common and the local arm. There were no statistically significant differences in the SNA and ANB angles between the common arm in Trial 1a (mean SNA 77.8, mean ANB 2.6) and Trial 2a (mean SNA 79.8, mean ANB 3.6) and no difference between Trial 1a and Trial 3a, but a statistical difference could be seen between Trial 2a and Trial 3a (mean SNA 76.9, mean ANB 1.7). However, the confidence interval was rather large. Intra- and inter-rater reliability were within acceptable range. Conclusions The timing and the surgical method is not of major importance as far as growth outcomes (SNA and ANB) in UCLP are concerned. Registration ISRCTN29932826 Protocol The protocol was not published before trial commencement.

One- or Two-Stage Palate Closure in Patients with Unilateral Cleft Lip and Palate: Comparing Cephalometric and Occlusal Outcomes

2007 ◽  
Vol 44 (1) ◽  
pp. 13-22 ◽  
Author(s):  
Silke Stein ◽  
Anton Dunsche ◽  
Nils-Claudius Gellrich ◽  
Franz Härle ◽  
Irmtrud Jonas
Keyword(s):  
Surgical Treatment ◽  
Soft Palate ◽  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Facial Growth ◽  
Arch Width ◽  
One Stage ◽  
Lateral Cephalograms ◽  
Cast Analysis

Objective: To assess facial growth and dentoalveolar development in two groups of patients with complete unilateral cleft lip and palate. Primary surgical treatment differed in the timing of hard palate closure. Design: Forty-three patients with unilateral cleft lip and palate were examined. Twenty-two patients underwent early one-stage closure of the hard and soft palate cleft (mean age 23.0 ± 4.7 months); in 21 patients, the hard palate closure was delayed to 86.3 ± 39.2 months of age. Lateral cephalograms and dental casts were consecutively analyzed at four stages between 6 and 18 years of age. Results: Lateral cephalometric analysis revealed no significant intergroup differences in the sagittal and vertical craniofacial dimensions at any time. Dental cast analysis showed constriction of the upper anterior arch width at the ages of 6 and 10 years in patients with one-stage surgical palate closure, but a difference could no longer be verified at the ages of 15 and 18 years. Conclusions: The transverse distances in the upper jaw developed initially more positively in the group with delayed hard palate closure, but it became apparent later that the transverse deficiency after one-stage palate closure could be compensated for. When considering surgical treatment in general, the advantages of the delayed hard palate closure must be weighed against criteria favoring the early one-stage closure of the hard and soft palate.

Influence of Infant Cleft Dimensions on Velopharyngeal Function in 5-Year-Old Danish Children Born With Unilateral Cleft Lip and Palate

2019 ◽  
Vol 57 (4) ◽  
pp. 420-429
Author(s):  
Susanna Botticelli ◽  
Annelise Küseler ◽  
Kirsten Mølsted ◽  
Helene Soegaard Andersen ◽  
Maria Boers ◽  
...  
Keyword(s):  
Soft Palate ◽  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Controlled Trial ◽  
Velopharyngeal Insufficiency ◽  
Primary Surgery ◽  
Multicenter Randomized Controlled Trial ◽  
Palate Repair ◽  
Velopharyngeal Function

Aim: To examine the association of cleft severity at infancy and velopharyngeal competence in preschool children with unilateral cleft lip and palate operated with early or delayed hard palate repair. Design: Subgroup analysis within a multicenter randomized controlled trial of primary surgery (Scandcleft). Setting: Tertiary health care. One surgical center. Patients and Methods: One hundred twenty-five infants received cheilo-rhinoplasty and soft palate repair at age 3 to 4 months and were randomized to hard palate closure at age 12 or 36 months. Cleft size and cleft morphology were measured 3 dimensionally on digital models, obtained by laser surface scanning of preoperative plaster models (mean age: 1.8 months). Main outcome measurements: Velopharyngeal competence (VPC) and hypernasality assessed from a naming test (VPC-Sum) and connected speech (VPC-Rate). In both scales, higher scores indicated a more severe velopharyngeal insufficiency. Results: No difference between surgical groups was shown. A low positive correlation was found between posterior cleft width and VPC-Rate (Spearman = .23; P = .025). The role of the covariate “cleft size at tuberosity level” was confirmed in an ordinal logistic regression model (odds ratio [OR] = 1.17; 95% confidence interval [CI]:1.01-1.35). A low negative correlation was shown between anteroposterior palatal length and VPC-Sum (Spearman = −.27; P = .004) and confirmed by the pooled scores VPC-Pooled (OR = 0.82; 95% CI: 0.69-0.98) and VPC-Dichotomic (OR = 0.82; 95% CI: 0.68-0.99). Conclusions: Posterior cleft dimensions can be a modest indicator for the prognosis of velopharyngeal function at age 5 years, when the soft palate is closed first, independently on the timing of hard palate repair. Antero-posterior palatal length seems to protect from velopharyngeal insufficiency and hypernasality. However, the association found was significant but low.

Two-Stage Palate Repair with Delayed Hard Palate Closure Is Related to Favorable Maxillary Growth in Unilateral Cleft Lip and Palate

2010 ◽  
Vol 125 (5) ◽  
pp. 1503-1510 ◽  
Author(s):  
Yu-Fang Liao ◽  
I-Ying Yang ◽  
Ruby Wang ◽  
Claudia Yun ◽  
Chiung-Shing Huang
Keyword(s):  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Two Stage ◽  
Palate Repair ◽  
Maxillary Growth

Comparison of Velopharyngeal Growth Patterns between Cleft Lip and/or Palate Patients Requiring or Not Requiring Pharyngeal Flap Surgery

1994 ◽  
Vol 31 (6) ◽  
pp. 452-460 ◽  
Author(s):  
Mohammad Mazaheri ◽  
Athanasios E. Athanasiou ◽  
Ross E. Long
Keyword(s):  
Cleft Palate ◽  
Soft Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Growth Curves ◽  
Growth Patterns ◽  
Flap Surgery ◽  
Velopharyngeal Incompetence ◽  
Lateral Cephalograms ◽  
Pharyngeal Flap

This investigation compares the patterns of velopharyngeal growth in cleft lip and/or palate patients. Those who had velopharyngeal competence and acceptable speech are compared with those who presented with velopharyngeal incompetence requiring pharyngeal flap surgery or prosthesis later. Lateral cephalograms of 30 cleft palate only (CPO), 35 unilateral cleft lip and palate (UCLP), and 20 bilateral cleft lip and palate (BCLP) children of the Lancaster Cleft Palate Clinic were studied. These records were taken at 6 month intervals during the first 2 postnatal years and annually thereafter up to 6 years of age. Soft tissue landmark points in the velopharyngeal region were digitized. Length and thickness of the soft palate and height and depth of the nasopharynx were measured. Evaluation of the growth curves of these four cephalometric variables indicated only two significant differences between children who later required pharyngeal flap surgery and those who did not. These differences were found in the growth in length of the soft palate of the CPO group and in the growth in depth of the nasopharynx of the BCLP group. Based on the present cephalometric data, it is Impossible to predict at an early age those cleft lip and/or palate patients who will later require pharyngeal flaps.

An Uncommon Cleft Subtype of Unilateral Cleft Lip and Palate

2008 ◽  
Vol 87 (2) ◽  
pp. 164-168 ◽  
Author(s):  
T. Yamanishi ◽  
C. Kobayashi ◽  
I. Tsujimoto ◽  
H. Koizumi ◽  
S. Miya ◽  
...  
Keyword(s):  
Crucial Role ◽  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
First Year ◽  
Maxillary Growth ◽  
Palatal Development

The finding that the vomer plays a crucial role in maxillary growth suggests that the bilateral cleft configuration of unilateral cleft lip and palate (UCLP), in which the vomer is detached from the non-cleft-side secondary hard palate, negatively influences palatal development, and this hypothesis was tested. Sixty persons with complete UCLP, including those with the vomer detached from (n = 30, b-UCLP) and attached to (n = 30, u-UCLP) the secondary hard palate, were analyzed morphologically, with the use of cast models taken at 10 days, 3 mos, and 12 mos of age. The anterio-posterior palatal length at 12 mos of age in those with b-UCLP was significantly shorter than that in those with u-UCLP, by 8.7% (p < 0.05). In addition, palatal width development in the first year in those with b-UCLP was also significantly retarded. These results suggest that the uncommon bilateral cleft subtype in UCLP should be included in the cleft classification.

Do Infant Cleft Dimensions Have an Influence on Occlusal Relations? A Subgroup Analysis Within an RCT of Primary Surgery in Patients With Unilateral Cleft Lip and Palate

2019 ◽  
Vol 57 (3) ◽  
pp. 378-388
Author(s):  
Susanna Botticelli ◽  
Annelise Küseler ◽  
Agneta Marcusson ◽  
Kirsten Mølsted ◽  
Sven E. Nørholt ◽  
...  
Keyword(s):  
Soft Palate ◽  
Subgroup Analysis ◽  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
3D Analysis ◽  
Primary Surgery ◽  
Size And Morphology ◽  
Crude Analysis ◽  
Closure Group

Aim: To investigate whether infant cleft dimensions, in a surgical protocol with early or delayed hard palate closure, influence occlusion before orthodontics. Design: Subgroup analysis within a randomized trial of primary surgery (Scandcleft). Setting: Tertiary health care. One surgical centre. Patients and Methods: A total of 122 unilateral cleft lip and palate infants received primary cheilo-rhinoplasty and soft palate closure at age 4 months and were randomized for hard palate closure at age 12 versus 36 months. A novel 3D analysis of cleft size and morphology was performed on digitized presurgical models. Occlusion was scored on 8-year models using the modified Huddarth–Bodenham (MHB) Index and the Goslon Yardstick. Main Outcome Measurements: Differences in MHB and Goslon scores among the 2 surgical groups adjusted for cleft size. Results: The crude analysis showed no difference between the 2 surgical groups in Goslon scores but a better MHB ( P = .006) for the group who received delayed hard palate closure. When adjusting for the ratio between cleft surface and palatal surface (3D Infant Cleft Severity Ratio) and for posterior cleft dimensions at tuberosity level, the delayed hard palate closure group received 3.65 points better for MHB (confidence interval: 1.81; 5.48; P < .001) and showed a trend for reduced risk of receiving a Goslon of 4 or 5 ( P = .052). For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group ( P = .033). Conclusions: Seen from an orthodontic perspective, when the soft palate is closed first, and the cleft is large, the timing of hard palate closure should be planned in relation to posterior cleft size.

Gingivoperiosteoplasty and Midfacial Growth

1997 ◽  
Vol 34 (1) ◽  
pp. 17-20 ◽  
Author(s):  
Robert J. Wood ◽  
Barry H. Grayson ◽  
Court B. Cutting
Keyword(s):  
New York ◽  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Medical Center ◽  
New York University ◽  
Lateral Cephalogram ◽  
Primary Surgery ◽  
Lateral Cephalograms ◽  
Significant Difference

The objective of this study was to report the effect of gingivoperiosteoplasty on growth of the midfacial skeleton 6 years following primary surgical repair. Patients with complete unilateral cleft lip and palate who underwent primary cleft lip and nose repair with and without gingivoperiosteoplasty (GPP) were retrospectively compared by means of a lateral cephalogram. Mean age at the time of evaluation was 5.7 years. All patients were treated at the Institute of Reconstructive Plastic Surgery, New York University Medical Center. All surgery and presurgical orthopedics was performed by the same surgeon and the same orthodontist. Twenty-five consecutively treated patients who presented with complete unilateral clefts of the primary and secondary palate were included in the study. Of these, 20 patients were available for 6-year follow-up cephalometric documentation and review. All patients received preoperative orthopedics with passive molding appliances, followed by repair of the lip, alveolus, and nose in a single stage at the age of 3 months. The repair was performed using the rotation/advancement technique. The difference between the two groups was whether or not gingivoperiosteoplasty was performed. The reason for not performing gingivoperiosteoplasty was incomplete approximation of the alveolar segments usually due to a late start in beginning therapy. Lateral cephalograms (68.5 months post primary surgery) were obtained and traced. Cranial base (S–N), maxilla (ANS–PNS), and mandible (Go–Pg) were digitized for shape coordinate analysis. No significant difference in the mean position of ANS–PNS was found between groups (with or without gingivoperiosteoplasty). There was, however, a significant difference In the variance of position for the points ANS–PNS between the groups (p<.002). We were unable to observe any difference (anteroposterior or supero-inferior) in the average position of the hard palate (ANS–PNS) between groups. We conclude that gingivoperiosteoplasty results in a more uniform position of the hard palate (ANS–PNS) relative to patients that did not receive gingivoperiosteoplasty. We were unable to demonstrate any clear impairment of maxillary growth in the patients treated with gingivoperiosteoplasty when compared to patients treated without gingivoperiosteoplasty.

Maxillary Growth in Cleft Lip and Palate Patients, With and Without Vomerine Flap Closure of the Hard Palate at the Time of Lip Repair

2018 ◽  
Vol 55 (9) ◽  
pp. 1205-1210 ◽  
Author(s):  
Norman Hay ◽  
Brijesh Patel ◽  
Priya Haria ◽  
Brian Sommerlad
Keyword(s):  
United Kingdom ◽  
Hard Palate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
The United Kingdom ◽  
Study Support ◽  
Maxillary Growth ◽  
Flap Closure ◽  
Anterior Posterior

Objective: To assess the midterm effect on maxillary growth of vomerine flap (VF) closure of the hard palate, at the time of lip repair. Design: A retrospective analysis of prospectively collected nonrandomized data. Interventions: Consecutive participants with a unilateral cleft lip and palate (UCLP) were operated on, at 3 months of age, by the same surgeon. They were divided into 2 groups, those who had a VF and those who did not (non-VF). Setting: Participants were treated at 2 hospitals in the United Kingdom. Participants: Twenty-eight participants in the VF group and 24 participants in the non-VF group attended follow-up at 10 years of age. Main Outcome Measures: Standardized lateral cephalometric radiographs were taken at 10 years. Following tracing and digitization, parameters to assess the maxillary growth were analyzed. Results: No statistically significant differences were found in the anterior–posterior or vertical skeletal cephalometric parameters. Conclusions: The results of this study support the statement that VF repair does not significantly affect maxillary growth in patients with a UCLP, when assessed cephalometrically at 10 years of age. It should be noted that at this age, growth is not yet complete.

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