Table S1: The demographic information of the subjects, selection criteria, dependent and independent variables, armamentarium and statistical analyses of the study
Selection criteria Inclusion
• Non-syndromic UCLP children.
• Individuals aged 5-12 years.
• Dental casts were taken before any orthodontic treatment and bone grafting.
• Cheiloplasty and palatoplasty had been performed.
Exclusion
• Associated anomalies or syndromes were excluded from the study.
Study design Cross-sectional study
Source of Population Malay ethnic group (Confirmation through communication with parents)
Study Sample Patient’s clinical records and dental casts from the archive of School of Dental Sciences, Universiti Sains Malaysia.
Sample size calculation
The sample size calculation was done based on a ratio of 1 factor: 5 cases. In our study, there are eight factors. Thus the estimated sample was 40. (according to Hair et al(27), the minimum ratio of observation is 1:5)
Following the strict inclusion and exclusion criteria, finally, 85 sample has been selected for this study.
Demographic Information: (Independent variables)
Age Gender UCLP Type
Early mixed (5-8 years): 45 Male: 50
Complete UCLP: 25
Late mixed (9-12 years): 40 Female: 35
Incomplete UCLP: 60 UCLP Side
F/H of Cleft F/H of C-III Techniques of Palatoplasty Techniques of Cheiloplasty
Right: 28 Positive: 18 Positive: 7
Bardach Technique: 29
Millard Technique: 54
Left: 57 Negative: 67 Negative: 78
Von-Lengenbeck Technique: 56
Modified Millard Technique: 31
Dependent Variables Inter-canine Width
(ICW)
Inter-molar width (IMW)
Arch depth (AD)
• The distance between cusp tips of the upper deciduous canines (Figure 1).
• The distance between the mesiolingual cusps or centers of the corresponding facets of the upper deciduous first molars (Figure 1).
• A perpendicular line from the mesial contact area of the central incisor to inter first molar width (Figure 1).
Research Tools 1. Patient’s clinical records and dental casts.
2. Laser scanned 3D digital model (LS3DM).
3. Next engine laser scanner machine.
4. Mimics software for measurements of maxillary arch dimension.
Statistical Analyses 1. Intra-class correlation coefficient has been used to determine intra- and inter-examiner reliabilities.
2. Multiple linear regression analyses were used to evaluate the association between multiple factors and treatment outcome.
3. All the analyses have been carried out using the statistical package SPSS Version 24.0 (SPSS Inc., Chicago, IL, USA).
4. The significance level has been set at p <0.05.
Table S2: The effects of multiple factors on inter canine width (ICW), inter molar width (IMW) and arch depth (AD) (* p < 0.05.)
Variable Unstandardized
Coefficients Standardized Coefficients
Beta
t p
Value B Std. Error
Inter Canine Width
Age -1.463 1.403 -0.132 -1.043 0.302 Gender -0.375 1.313 -0.037 -0.285 0.776 UCLP Type -0.916 1.287 -0.085 -0.711 0.480 UCLP Side -0.290 1.319 -0.028 -0.220 0.827 F/H Cleft 1.044 1.434 0.096 0.728 0.470 F/H C-III -0.346 2.259 -0.019 -0.153 0.879 Cheiloplasty -4.697 1.271 -0.453 -3.696 0.001* Palatoplasty 2.650 1.293 0.258 2.049 0.046*
Inter Molar Width
Age -0.403 1.236 -0.038 -0.326 0.745
Gender -1.278 1.121 -0.133 -1.140 0.258
UCLP Type 1.508 1.185 0.145 1.273 0.207
UCLP Side -0.189 1.144 -0.019 -0.165 0.869
F/H Cleft -1.961 1.177 -0.191 -1.666 0.100
F/H C-III 0.733 1.947 0.043 0.377 0.707
Cheiloplasty -1.839 1.141 -0.187 -1.611 0.111
Palatoplasty 1.257 1.154 0.126 1.090 0.279
Arch Depth
Age -0.059 1.490 -0.005 -0.040 0.969
Gender -2.249 1.351 -0.194 -1.664 0.100
UCLP Type 2.212 1.428 0.176 1.549 0.126
UCLP Side -0.329 1.379 -0.027 -0.239 0.812
F/H Cleft -1.039 1.419 -0.084 -0.732 0.466
F/H C-III -0.724 2.346 -0.035 -0.309 0.758
Cheiloplasty -2.512 1.376 -0.212 -1.826 0.072
Palatoplasty 1.356 1.391 0.113 0.975 0.333
UCLP: unilateral cleft lip and palate; F/H Cleft: Family history of cleft; F/H C-III: Family history of class III malocclusion.
Table S3: Comparison of the mean dimension of the two techniques of cheiloplasty and palatoplasty with the mean dimension of control group of Gopinath et al (13)
Cheiloplasty N Mean (SD) Palatoplasty N Mean (SD) Mean (SD) of CG**
ICW MT 38 28.71 (4.6) BT 23 25.37 (3.7) 30.6 (2.3)
MMT 22 23.61 (4.1) VLT 37 27.75 (5.6)
IMW MT 54 45.62 (4.7) BT 29 44.26 (4.7) 46.4 (2.6)
MMT 31 44.58 (4.8) VLT 56 45.74 (4.7)
AD MT 54 30.41 (6.4) BT 29 28.60 (4.6) 30.0 (3.5)
MMT 31 28.78 (4.2) VLT 56 30.44 (6.2)
MT: Millard technique; MMT: modified Millard technique; BT: Bardach Technique; VLT: Von-Lengenbeck Technique. **copied from Gopinath et al [13]
Table S4: Evaluation of treatment outcome by assessing maxillary arch dimension of UCLP children from different countries
Author Population Measurement Sample size Method Outcome Gopinath et al
(13) Malaysia ICW
IPW IMW
AD AL
UCLP: 48 Dental cast ICW and IPW were significant smaller in UCLP compared to the control group.
Cassi et al
(15) Italy ICW
IMW CLP: 28 Dental cast Significant differences found in ICW between two groups.
Carrara et al
(16) Brazil ICW
ITW AL
UCLP: 114 3D digital
model Significant differences found in AL between pre- cheiloplasty and 1 year after palatoplasty.
Santos et al
(17) Brazil ICW
IMW (P) IMW (D)
UCLP: 72
CG: 20 Dental cast ICW was significant smaller in UCLP compared to the control group.
Wahaj and
Ahmed (18) Pakistan ICW
IMW CLP: 32
CG: 32 Dental cast ICW was significant smaller in UCLP compared to the control group.
Garib et al
(20) Brazil ICW
IMW (P) IMW (D)
UCLP: 72
CG: 20 Dental cast ICW was significant smaller in UCLP compared to the control group.
Lewis et al
(21) England ICW
IMW UCLP: 30
CG:30 2D model
Photographs ICW was significant smaller in UCLP compared to the control group.
Kitagawa et al
(22) Japan ICW
IMW (D) AL
UCLP:34 3D digital
model Significant differences found between two groups
Al-Gunaid et
al (31) Japan ICW
IMW IPW
UCLP: 32 Dental cast Significant difference found in IPMW and IMW.
Garrahy et al
(32) Caucasian ICW
IMW AD
UCL: 11 UCLP: 16
CG: 78
Dental cast Significant difference found in IMW between UCL and CG.
The maxillary arch dimensions were significantly greater in the
CG compared to UCLP group.
Helio¨ vaara
et al (33) Finland ICW
IMW (1st) IMW (2nd)
AW
UCLP: 68 Dental cast No significant difference found between who later needed orthognathic surgery and those who did not.
Mello et al
(34) Brazil ICW UCLP: 50
BCLP: 25 CG: 19
3D digital
model Significant differences found
Kozˇelj et al
(35) Europe Transversal D Vertical D
Sagittal D
UCLP: 129
CG: 30 Dental cast Significant difference found between the dimensions for five cleft groups and CG.
Bongaarts et
al (36) Netherlands AW
AD AL Arch form Vertical D
UCLP:54 Dental cast No significant differences found between IO+ and IO- group
Marcusson and Paulin
(37)
Sweden ICW
IMW AL
UCLP:39 Dental cast Significant differences found
Zinah et al
(38) Iraq ICW
IMW ICL
UCLP: 30
CG: 30 Dental cast ICW and ICL were found significantly narrower in UCLP group compared to CG.
CG: control group (healthy non cleft group)