Original Article

The Cleft Palate-Craniofacial Journal

1-10
Is Taping Alone an Efficient Presurgical ª 2020, American Cleft Palate-
Craniofacial Association

Infant Orthopedic Approach in Infants With Article reuse guidelines:

sagepub.com/journals-permissions
DOI: 10.1177/1055665620944757
Unilateral Cleft Lip and Palate? A journals.sagepub.com/home/cpc

Randomized Controlled Trial

Mohamed Abd El-Ghafour, BDS, MSc, PhD, M Orth RCSEd1 ,

Mamdouh A. Aboulhassan, MD2, Amr Ragab El-Beialy, MSc, PhD, MOrth RCSEd1 ,
Mona M. Salah Fayed, BDS, MSc, PhD1, Faten Hussein Kamel Eid, BDS, MSc, PhD1,
Mahmoud El-Gendi, BDS1, and Dawlat Emara, MD3

Abstract
Objective: The aim of the current randomized controlled trial (RCT) was to assess the effectiveness of taping alone in changing the
maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair.
Design: A prospective, balanced, randomized, parallel-group, single-blinded, controlled trial.
Setting: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt.
Participants: Thirty-one, nonsyndromic infants with UCLP.
Interventions: The eligible infants were randomly assigned to either no-treatment (control) or taping groups. In the taping group, all
the infants received horizontal tape between the 2 labial segments aiming to decrease the cleft gap. No other interventions were
performed to infants included in this group. Rubber base impressions were made to all the included infants in both groups at the
beginning of the treatment (T1) and directly before surgical lip repair (T2). All the produced models were scanned using a desktop
scanner producing digital models for outcome assessment.
Main Outcomes Measures: A blinded assessor carried out all the MAD measurements virtually on the produced digital models at
the beginning (T1) and after (T2) treatment.
Results: Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before
surgical lip repair in comparison to the control group.
Conclusions: It seems that taping alone is an efficient tool in changing the MADs before surgical lip repair in infants with UCLP.

Keywords
cleft lip and palate, presurgical infant orthopedics, taping

Introduction
Management of patients with cleft lip and palate (CLP) is a
1
long journey that requires a lot of effort and time (Mossey Department of Orthodontics, Faculty of Dentistry, Cairo University, Egypt
2
Department of Pediatric Plastic Surgery, Faculty of Medicine, Cairo
and Modell, 2012). Any simple and efficient approach will University, Egypt
be beneficial and markedly appreciated to minimize the 3
Department of Plastic Surgery, Faculty of Medicine, Cairo University, Egypt
efforts consumed in the lifelong CLP management
protocol. Corresponding Author:
As an early intervention at infancy, presurgical infant ortho- Mohamed Abd El-Ghafour, Royal College of Surgeon Edinburgh, United
Kingdom; American Cleft Palate-Craniofacial Association (ACPA);
pedics (PSIO) were assessed in the literature for efficiency in Department of Orthodontics, Faculty of Dentistry, Cairo University, Cairo,
improving the anatomy of the structures surrounding the cleft Egypt.
defect, aiming to achieve a better surgical outcome. Decreasing Email: m.abdelghafour@dentistry.cu.edu.eg
2 The Cleft Palate-Craniofacial Journal XX(X)

the size of the cleft gap between the 2 maxillary alveolar seg-
ments was mentioned to be beneficial in improving the surgical
lip repair by decreasing the tension on the surgical wound
(Friede and Lilja 1994; Lisson et al., 1999). Several types of
PSIO were mentioned in the literature (Hoffman et al., 1686;
Brophy, 1923; McNeil, 1956; Latham et al., 1976; Hotz et al.,
1978; Grayson et al., 1993) with a wide range of aggressiveness
and effectiveness. Some studies were supporting the idea of
PSIO usage as an important step in the CLP management pro-
tocol, while others refused the whole idea (Uzel and Alparslan,
2011; de Ladeira and Alonso, 2012; Papadopoulos et al., 2012;
Abbott and Meara, 2012; van der Heijden et al., 2013; Hosseini
et al., 2017).
Lip taping alone is considered as an oppressed type of
PSIOs. Taping was not thoroughly discussed in the literature
for its usefulness in improving the cleft condition before the
surgical lip repair. By searching the literature, only 2 articles
(Pool and Farnworth, 1994; Dawjee et al., 2014) were found
assessing the results of taping alone. The 2 published articles
(Pool and Farnworth, 1994; Dawjee et al., 2014) were case
series and found positive results of taping in molding the 2
maxillary alveolar segments and decreasing the cleft gap.
Moreover, both articles (Pool and Farnworth, 1994; Dawjee
et al., 2014) mentioned that taping is a very simple and inex-
pensive procedure to reduce the severity of the cleft defect.
The aim of the current randomized controlled trial (RCT)
Figure 1. Tape in place (above) and tape in place with the protecting
was to assess the effectiveness of taping alone in changing the
pad (below).
maxillary arch dimensions (MADs) in infants with unilateral
complete cleft lip and palate (UCLP) before surgical lip repair.
complete cleft palate, medically free subjects, and both males
and females. All the steps of the current RCT were performed
Materials and Methods by the principal operator (M.A.) in the outpatient clinic of the
Department of Orthodontics, Faculty of Dentistry, Cairo
This RCT followed the CONSORT (Consolidated Standards of University.
Reporting Trials) guidelines (Moher et al., 2010) for reporting
RCTs allowing a detailed description of the study interventions
and assessment methods. Interventions
Upon receiving a new infant (at T1: before starting any treat-
Trial Design and Registration ment), 2-step rubber-based maxillary impression was made.
The current study was conducted in a balanced, randomized, Rubber-based impression material (Zetaplus-Zhermack—putty
parallel-group, single-blinded, controlled trial design which and light) was used with 2 different viscosities: putty and light.
was conducted in Egypt. A large group of participants with All the impressions were made using an acrylic impression tray
matching baseline characteristics was randomly distributed made on previous models. The impressions were poured with
into 2 parallel groups with allocation ratio 1:1. The 2 groups hard stone. At T2 (after taping and before surgical lip repair),
were the taping alone group and the treatment controls. Trial another maxillary impression was made to all the included
registration was performed in ClinicalTrials.gov with the reg- infants in both groups.
istration number of NCT02845193. The trial’s protocol was Infants of the control group did not receive any intervention
registered on July 27, 2016. The protocol can be accessed but the 2-maxillary impressions at T1 and T2. In the taping
through https://clinicaltrials.gov/ct2/show/NCT02845193. The group, the patients received a single horizontal tape (3 M Steri-
study was reviewed and approved by the Ethics Committee of strips 1/4 inch) stretching the 2 labial segments toward each
the Faculty of Dentistry, Cairo University, and its whole pro- other, aiming to decrease the interlabial gap (Figure 1). The
cess was supervised. parents were instructed to place the tape 24 h/d and to be
Thirty-one infants with complete UCLP were recruited in changed every day (Supplemental Video 1).
the current study. All the infants were recruited with the fol- The follow-up visits were every 2 weeks to make sure that
lowing inclusion criteria: infants with an age range from 1 to the instructions were followed. If any inflammation occurred to
30 days, unilateral complete cleft lip and alveolus, presence of the skin, the parents were instructed to use an aerobic batch of
Abd El-Ghafour et al 3

tape. They were instructed to change it every 2 to 3 days. It intervention, it was impossible to blind both the patients and
acted as a base for the Steri-strips to be changed without further the principal operator.
skin irritation (Figure 1).

Statistical Methods
Outcomes
The significance level was set at P  .05. Statistical analysis
The outcome of this RCT was to measure the effectiveness of was performed with IBM SPSS Statistics Version 20 for Win-
taping in changing the MADs in comparison to the control dows. Handling of data was done using Microsoft Excel
group in infants with UCLP. This was assessed as the differ- software.
ence between T1 (at the start of the treatment) and T2 (after Interclass correlation coefficients (ICC) were calculated to
taping and before surgical lip closure at nearly 3 months of detect the intra- and interobserver reliability of the measure-
age). All the T1 and T2 models were scanned using a desktop ments in the study. The closer the ICC to 1.0, the higher was the
scanner (3shape Lab Scanner-R500) upon which all the land- reliability of the measurement.
marks were identified and measurements were carried out. Data were explored for normality using Kolmogorov-
Using a software (3shape Ortho Control Panel), a custom anal- Smirnov and Shapiro-Wilk tests. According to the behavior of
ysis was constructed including landmarks, lines, and distances the data (either parametric or nonparametric), a suitable statis-
mentioned in Table 1 and Figure 2. Landmark identification tical test was selected.
was completed using the measuring module in the used soft- The means, SD, and confidence intervals were calculated
ware (3shape Ortho Analyzer). After landmark identification, for each group in each test. For normally distributed data, inde-
the software automatically generated the aforementioned pendent sample t test was used to compare the 2 groups. For
measurements. each group, paired sample t test was used to compare the 2 time
points. Due to the normal distribution of data, the nonpara-
metric tests were not used in the current study.
Sample Size
Calculation of the sample size was done using data from the
previous study (Yu et al., 2013) that measured the maxillary
arch changes in infants with UCLP. Means and SDs of the Results
anterior cleft gap of both the intervention and control groups Participant Flow, Dropouts, and Numbers Analyzed
were used. By setting the power of 80%, type I error of 5%, and
using independent sample t test, effect size of 1.59 resulted. For the taping group, all the 14 infants received the tapes. No
The calculation resulted in the inclusion of 8 infants in each dropouts had occurred in this group. While in the control group,
group. In the current trial, this number was increased to 17 in 17 infants were allocated. Two infants died, one due to chest
each group to avoid any dropouts and to prevent the attrition infection and the other due to a cardiac problem. One more
bias. infant was lost as his family chose to complete the follow-up in
a nearby hospital. The records of all 14 infants of the control
group were analyzed (Figure 3).
Randomization
The randomization process was strictly followed by applying
Recruitment
its 3 steps: Starting with sequence generation using Microsoft
Office Excel 2013 sheet, followed by allocation concealment The first infant was allocated on November 13, 2016, while the
by writing the random numbers on opaque white papers, each last infant started treatment on September 9, 2018. All the
was folded 8 times and kept in opaque sealed envelopes, then patients were followed for 3 months.
kept in 15  15 cm sealed box the until the time of implemen-
tation. Finally, implementation was performed by blinded
implementer upon receiving a new eligible infant to identify
Baseline Data
his/her allocation group. For the taping group, 14 UCLP were included; 9 of them had
the cleft on the left side and 5 had it on the right side. In this
group, the age of the included infants at the start of the treat-
Blinding ment was a mean of 12.07 (+6.96) days including 7 males and
The current trial is considered as a single-blinded study; blind- 7 females. The control group included 14 UCLP infants divided
ing was done only to the outcome assessors. The first assessor into 12 infants with left side cleft and 2 with right side cleft.
was responsible for placing the landmarks on all the digital The control group participants had a mean age of 12.74
models and repeat 20% of the measurements after 2 weeks to (+7.28) days encompassing 8 males and 6 females. Most of
measure the intraobserver reliability. The second assessor the 28 included infants in the study had cleft on the left side
placed the landmarks on the same 20% of the sample to mea- recording ratio 3 left:1 right. Moreover, the male to female
sure the interobserver reliability. Due to the nature of the ratio was 1.15 male:1 female.
4 The Cleft Palate-Craniofacial Journal XX(X)

Table 1. Definition of Landmarks and Measurements.

Landmarks

Landmark Abbreviation Definition

1 Greater segment anterior point G The anterior end of the greater segment along the crest of the alveolar ridge.
2 Lesser segment anterior point L The anterior end of the lesser segment along the crest of the alveolar ridge.
3 Incisive point I The intersection of the crest of the alveolar ridge and line drawn from the labial frenum
to the incisive papilla.
4 Canine point of the greater segment C The intersection of the anterolateral sulcus and the crest of the alveolar ridge of the
greater segment.
5 Canine point of the lesser segment C’ The intersection of the anterolateral sulcus and the crest of the alveolar ridge of the
lesser segment.
6 Gingival groove point of the greater Q The intersection between the gingival groove (junction between the attached gingival and
segment alveolar mucosa) and the anterolateral sulcus of the greater segment.
7 Gingival groove point of the lesser Q’ The intersection between the gingival groove (junction between the attached gingival and
segment alveolar mucosa) and the anterolateral sulcus of the lesser segment.
8 Tuberosity point of the greater segment T The posterior limit of the crest of the alveolar ridge of the greater segment.
9 Tuberosity point of the lesser segment T’ The posterior limit of the crest of the alveolar ridge of the lesser segment.
Constructed points
Point Abbreviation Definition
1 Canine palatal point of the greater segment c The point at the intersection between C-C’ line and cleft margin of the greater segment.
2 Canine palatal point of the lesser segment c’ The point at the intersection between C-C’ line and cleft margin of the lesser segment.
3 Middle palatal point of the greater m The intersection of cleft margin and a line connecting points C and Q on the greater
segment segment.
4 Middle palatal point of the lesser segment m’ The intersection of cleft margin and a line connecting points C’ and Q’ on the lesser
segment.
5 Posterior palatal point of the greater t The point at the intersection between T-T’ line and cleft margin of the greater segment.
segment
6 Posterior palatal point of the lesser t’ The point at the intersection between T-T’ line and cleft margin of the lesser segment.
segment
7 Point Z Z Point of intersection of perpendicular line from point I to T-T’ line.
8 Point F F Point of intersection of perpendicular line from point I to C-C’ line.
9 Point Y Y Point of intersection of perpendicular line from point G to T-T’ line.
10 Point N N Point of intersection of perpendicular line from point L to T-T’ line.
11 Point X X Point of intersection of perpendicular line from point L to GY line.
12 Point E E The point at the intersection between LX line and cleft margin of the greater segment.
13 Point O O Mid-line point on T-T’ line.
Measurements
Measurement Abbreviation Definition
I. Cleft widths
1 Anterior cleft width ACW (G-L) Distance between points G and L.
2 Canine cleft width CCW (c-c’) Distance between points c and c’.
3 Middle cleft width MCW (m-m’) Distance between points m and m’.
4 Posterior cleft width PCW (t-t’) Distance between points t and t’.
II. Arch widths
5 Intercanine region width ICW (C-C’) Distance between points C and C’.
6 Middle arch width MAW (Q-Q’) Distance between points Q and Q’.
7 Posterior arch width PAW (T-T’) Distance between points T and T’
III. Anteroposterior measurements
8 Greater segment position GSP (GY) Distance between points G and Y.
9 Greater segment length GSL (G-C-T) Distance between points G and C plus distance between points C and T.
10 Lesser segment position LSP (LN) Distance between points L and N.
11 Lesser segment length LSL (LT’) Distance between points L and C’ plus distance between points C’ and T’.
12 Anterior arch length AAL (IF) Distance between points I and F.
13 Total arch length TAL (IZ) Distance between points I and Z.
14 Greater to lesser segment relation GLR (GX) Distance between points G and X.
IV. Maxillary segments angulations
15 Greater segment displacement GSD (GOT) Angle between points G, O, and T.
16 Lesser segment displacement LSD (LOT) Angle between points L, O, and T.
17 Arch symmetry AS (IOT) Angle between points I, O, and T.
Abd El-Ghafour et al 5

Figure 2. Landmarks (blue)—G: greater segment anterior point, L: lesser segment anterior point, I: incisive point, C/C’: canine points, Q/Q’:
gingival groove points and T/T’: tuberosity points. Constructed points (yellow)—c/c’: canine palatal points, m/m’: middle palatal points, t/t’:
posterior palatal points, Z: point Z, Y: point Y, N: point N, X: point X, E: point E, F: point F and O: point O. Cleft widths’ measurements (A)—1:
anterior, 2: canine, 3: middle, and 4: posterior cleft widths. Arch widths’ measurements (B); 5: intercanine region width, 6: middle arch width, and
7: posterior arch width. Anteroposterior measurements (C)—8: greater segment position, 9: greater segment length, 10: lesser segment
position, 11: lesser segment length, 12: anterior arch length, 13: total arch length, and 14: greater to lesser segment relation. Maxillary segments
angulations (D)—15: greater segment displacement, 16: lesser segment displacement, and 17: arch symmetry.

Outcomes and Estimation for the posterior arch width, greater segment position, lesser
segment position, anterior arch length, and total arch length,
 Intraobserver and interobserver reliability which showed statistically insignificant changes, despite their
clinically significant changes.
Intraobserver and interobserver reliability were assessed
between 2 readings done by the 2 assessors to the different  Control Group
measurements using the ICC. Acceptable intraobserver relia-
bility and agreement between all the readings (ICC values Unlike the taping group, most of the measurements in the
ranging from 0.752 to 0.990) were found except for the greater control group were insignificantly (P > .05) changed between
segment length, which recorded a weak reliability (ICC ¼ the 2 measured time points (Table 2). Significant changes
0.300). occurred only in the canine cleft width, anterior arch length,
For the interobserver reliability, acceptable reliability was and arch symmetry.
observed for most of the measurements (ICC values ranging
from 0.723 to 0.974). Some measurements recorded moderate  Differences between the 2 groups
interobserver reliability: middle cleft width (0.515), posterior
arch width (0.547), greater segment length (0.543), and arch At T2 (difference between T1 and T2), statistically signifi-
symmetry (0.632). cant differences were found between the 2 groups in 7 measure-
ments: anterior, canine and middle cleft widths, in addition to
 The Taping Group intercanine region width, middle arch width, greater to lesser
segments relation, and lesser segment displacement. Although
Most of the models’ measurements in the taping group were the rest of the measurements did not statistically differ, an
changed significantly (P < .05) while comparing the 2 mea- obvious clinical change had occurred in the taping group in
sured time points (Table 2 and Figure 4). This was not the case comparison to the control (Table 2).
6 The Cleft Palate-Craniofacial Journal XX(X)

Figure 3. CONSORT flow diagram of the progress through the phases of the current randomized controlled trial (RCT).

Harms amount of benefit might be much higher than predicted risks.

These benefits stood with the conduction of the current study.
An obvious amount of irritation and inflammation occurred to
By evaluating the other types of PSIOs, taping is considered
most of the infants in the area of tape placement. This some-
as the simplest type. The absence of the need for impression
times developed into an open wound with bleeding (Figure 5).
making and appliance construction allows the early start of the
The irritations were limited to the cheek areas where high
treatment and minimizes the expenses.
forces of traction were applied. No irritation had occurred at
All the previous trials (Pool and Farnworth, 1994; Dawjee
the lip repair area.
et al., 2014) assessing the efficiency of taping were lacking the
prospective design and the control group for comparison. Both
articles (Pool and Farnworth, 1994; Dawjee et al., 2014) were
Discussion case series with mixed unilateral and bilateral cases. Both stud-
A common demand in all medical specialties is simplifying ies reported that taping resulted in positive effects on both the
interventions and decreasing treatment duration. This demand MADs and lip aesthetics.
is much more intense while dealing with a lifelong condition
such as the management of patients with CLP. Taping is con-
sidered as a simple and inexpensive type of PSIO as mentioned
Limitations
by its users (Pool and Farnworth, 1994; Dawjee et al., 2014). Unavoidable limitation in the current study was the inability to
And by assessing its benefit–risk ratio (Leong et al., 2015), the blind both the principal operator and the parents. Intra- and
 Table 2. Mean and SD of the Different Models’ Measurements in the Taping and Control Groups at the 2 Time Points,a Followed by Mean Differences and CIs of the Different Measurements
Between the 2 Groups at T2 (T1-T2).b

Difference between the 2 groups at T2

Taping Control (T1-T2)

T1 T2 T1-T2 T1 T2 T1-T2

Mean Mean Mean

Measurements Mean SD Mean SD difference SD 95% CI P value Mean SD Mean SD difference SD 95% CI P value difference 95% CI P value
c
1 Anterior cleft width (mm) 12.54 2.84 6.29 3.23 6.25 3.16 8.07 to 4.42 <.001 12.94 3.35 12.85 3.16 0.10 1.30 0.81 to 0.62 .781NS 6.15 3.74 to 8.56 <.001c
2 Canine cleft width (mm) 13.79 2.46 8.15 3.15 5.64 2.54 7.09 to 4.17 <.001c 13.00 4.29 11.59 2.97 1.41 2.38 2.73 to 0.09 .038c 4.22 1.56 to 6.88 <.001c
3 Middle cleft width (mm) 16.29 2.74 12.43 3.46 3.86 3.42 5.83 to 1.88 <.001c 15.21 2.38 14.42 2.31 0.79 2.43 2.13 to 0.54 .255NS 3.06 0.45 to 5.67 <.015c
4 Posterior cleft width (mm) 16.78 3.06 13.54 3.50 3.24 4.02 5.56 to 0.92 .010c 15.12 3.27 14.42 2.67 0.70 2.68 2.18 to 0.78 .330NS 2.54 0.92 to 6.01 .222NS
5 Intercanine region width (mm) 31.19 3.17 26.09 3.07 5.10 3.63 7.20 to 3.00 <.001c 31.40 2.64 31.52 2.90 0.12 3.08 1.58 to 1.83 .878NS 5.22 2.04 to 8.40 <.001c
6 Middle arch width (mm) 25.58 2.42 20.67 2.92 4.91 2.80 6.52 to 3.29 <.001c 26.10 2.39 25.40 2.29 0.70 2.48 2.07 to 0.67 .292NS 4.20 1.86 to 6.54 <.001c
7 Posterior arch width (mm) 33.57 2.50 33.50 3.47 0.07 2.51 1.52 to 1.38 .919NS 36.51 2.36 37.80 2.36 1.28 2.68 0.20 to 2.76 .085NS 1.35 1.25 to 3.96 .521NS
8 Greater segment position (mm) 25.08 4.12 24.92 2.67 0.16 4.34 2.66 to 2.33 .889NS 23.72 3.56 25.36 2.05 1.64 3.43 0.25 to 3.54 .084NS 1.8 1.6 to 5.22 .502NS
9 Greater segment length (mm) 33.05 4.66 36.31 3.96 3.27 4.18 0.85 to 5.67 .012c 33.76 4.63 35.74 4.00 1.98 4.59 0.56 to 4.51 .117NS 1.28 5.43 to 2.85 .842NS
10 Lesser segment position (mm) 18.32 2.05 20.26 3.15 1.94 3.80 0.25 to 4.13 .079NS 17.30 3.01 17.67 2.87 0.38 3.68 1.66 to 2.41 .698NS 1.56 4.71 to 1.59 .560NS
11 Lesser segment length (mm) 22.48 2.48 25.98 3.48 3.50 4.17 1.09 to 5.90 .008c 22.00 4.11 23.44 3.67 1.44 3.50 0.49 to 3.37 .134NS 2.05 6.04 to 1.92 .523NS
12 Anterior arch length (mm) 8.32 2.27 8.35 2.29 0.02 2.05 1.15 to 1.20 .965NS 7.89 1.99 9.02 1.90 1.13 1.08 0.53 to 1.73 .001c 1.1 0.79 to 3.01 .418NS
13 Total arch length (mm) 21.79 3.31 22.84 2.87 1.05 4.16 1.35 to 3.44 .363NS 21.35 3.17 22.78 2.50 1.44 3.56 0.53 to 3.40 .140NS 0.39 3.05 to 3.84 .990NS
14 Greater to lesser segment relation (mm) 6.67 2.21 4.01 3.16 2.10 3.02 3.64 to 0.21 .016c 7.01 3.03 7.75 2.76 0.74 2.31 0.54 to 2.01 .238NS 2.66 0.19 to 5.13 .029c
15 Greater segment displacement ( ) 87.47 8.21 96.32 6.26 8.85 6.73 4.96 to 12.73 <.001c 86.87 8.77 89.14 9.09 2.27 5.92 1.01 to 5.54 .161NS 6.58 13.5 to 0.41 .072NS
16 Lesser segment displacement ( ) 117.06 5.93 107.41 7.03 9.64 8.83 14.74 to 4.54 <.001c 118.63 9.55 117.29 8.20 1.34 5.87 4.58 to 1.90 .391NS 8.30 1.01 to 15.58 .020c
17 Arch symmetry ( ) 71.86 7.45 78.82 6.18 6.96 6.29 3.32 to 10.59 <.001c 72.44 9.41 76.39 7.95 3.95 6.63 0.27 to 7.61 .037c 3.01 9.73 to 3.71 .637NS

Abbreviations: NS, nonsignificant (P > .05); SD, standard deviation.

a
Paired sample t test was used to compare between the 2 time points in each group.
b
Compared using the independent sample t test.
c
Significant (P < .05).

7
8 The Cleft Palate-Craniofacial Journal XX(X)

Figure 4. Progress occurred in the maxillary arches of 4 infants included in the taping group.

interoperator variability in tape placement and the different soft irritation on the tape placement area added the burden on both
tissue distortion degree between the different patients may be the infants and their parents. Once the aerobic batch of tape was
considered as other limitations. The occurrence of skin used as a protection, all the irritation subsided.
Abd El-Ghafour et al 9

Funding
The author(s) received no financial support for the research, author-
ship, and/or publication of this article.

ORCID iD
Mohamed Abd El-Ghafour, BDS, MSc, PhD, M Orth RCSEd
https://orcid.org/0000-0002-0870-1472
Amr Ragab El-Beialy, BDS, MSc, PhD, M Orth RCSEd https://
orcid.org/0000-0003-1303-3920

Supplemental Material
Supplemental material for this article is available online.
Figure 5. Skin irritation occurred in the area of tape placement.

References
Generalizability
Abbott MM, Meara JG. Nasoalveolar molding in cleft care: is it effi-
The selection of a high-quality study design following the cacious? Plast Recon Surg. 2012;130(3):659-666.
CONSORT guidelines and calculation of the sample size Brophy TW. Bone surgery essential in the treatment of complete cleft
needed were steps to increase the precision and minimize the palate. J Ame Dent Assoc. 1923;10(1):3-18.
amount of bias. Accordingly, this would increase the closeness Dawjee SM, Julyan JC, Krynauw JC. Lip tape therapy in patients with
of the selected sample to the population, which is needed to a cleft lip—a report on eight cases. SADJ. 2014;69(62):64-68,70.
increase the level of generalizability. de Ladeira PRS, Alonso N. Protocols in cleft lip and palate treatment:
systematic review. Plast Surg Int. 2012;2012:562892.
Interpretation of the Results Friede H, Lilja J. Dentofacial morphology in adolescent or early adult
patients with cleft lip and palate after a treatment regiment that
Taping alone was successful in changing the MADs clinically included Vomer flap surgery and pushback palatal repair. Scand J
and/or statistically. Despite of the matched measurements Plast Reconstr Surg Hand Surg. 1994;28(2):113-121.
between the taping and control groups at T1 before starting the Grayson B, Cutting C, Wood R. Preoperative columella lengthening in
treatment, a significant change was detected at T2 in the taping bilateral cleft lip and palate. Plast Reconstr Surg. 1993;92(4):
group only. These results match those reported by the case 1422-1423.
series. The results of the current study might help in improving Hoffmann J., De Labios leporinos, Hasenscharte V. Bergmann, Hei-
the outcome of the surgical lip repair. Postsurgical evaluation delberg; 1686.
may be needed in future studies to guarantee the effectiveness Hosseini HR, Kaklamanos EG, Athanasiou AE. Treatment outcomes
of taping alone. of pre-surgical infant orthopedics in patients with non-syndromic
Taping might be considered as an efficient, easy, simple, cleft lip and/or palate: a systematic review and meta-analysis of
and inexpensive type of PSIO. It might help families with randomized controlled trials. PloS One. 2017;12(1):e0181768.
transportation or economic problems in improving the condi- Hotz MM, Gnoinski WM, Nussbaumer H, Kistler E. Early maxillary
tion of their child with the least efforts. orthopedics in CLP cases: guidelines for surgery. Cleft Palate J.
1978;15(4):405-411.
Latham R, Kusy R, Georgiade N. An extraorally activated expansion
Conclusions appliance for cleft palate infants. Cleft Palate J. 1976;13:253-261.
Leong J, Salek S, Walker S. Benefit-Risk Assessment of Medicines.
Within the limitations of the current RCT, the following can be Springer; 2015.
concluded: Lisson J, Schilke R, Tränkmann J. Transverse changes after surgical
closure of complete cleft lip, alveolus and palate. Clin Oral Inves-
1. Taping alone is a successful type of PSIO. It was effi-
tig. 1999;3(1):18-24.
cient in changing the MADs in infants with UCLP
McNeil C. Congenital oral deformities. Br Dent J. 1956;101(2):
before surgical lip repair.
191-198.
2. Taping is considered as a simple and inexpensive type
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Dever-
of PSIO that can be used by families with transportation
eaux PJ, Altman DG. CONSORT 2010 explanation and elabora-
or economic problems.
tion: updated guidelines for reporting parallel group randomised
trials. BMJ (Clinical Research Ed.) 2010;23:340-c869.
Mossey P, Modell B. Epidemiology of oral clefts 2012: an interna-
Declaration of Conflicting Interests tional perspective. Front Oral Biol. 2012;16:1-18.
The author(s) declared no potential conflicts of interest with respect to Papadopoulos MA, Koumpridou EN, Vakalis ML, Papageorgiou SN.
the research, authorship, and/or publication of this article. Effectiveness of pre-surgical infant orthopedic treatment for cleft
10 The Cleft Palate-Craniofacial Journal XX(X)

lip and palate patients: a systematic review and meta-analysis. van der Heijden P, Dijkstra PU, Stellingsma C, van der Laan BF,
Orthod Craniofac Res. 2012;15(4):207-236. Korsten-Meijer AGW, Goorhuis-Brouwer SM. Limited evidence
Pool R, Farnworth TK. Preoperative lip taping in the cleft lip. Ann for the effect of presurgical nasoalveolar molding in unilateral cleft
Plast Surg. 1994;32(3):243-249. on nasal symmetry. Plas Recon Surg. 2013;131(1):62e-71e.
Uzel A, Alparslan ZN. Long-term effects of presurgical infant ortho- Yu Q, Gong X, Shen G. CAD presurgical nasoalveolar molding effects
pedics in patients with cleft lip and palate: a systematic review. on the maxillary morphology in infants with UCLP. Oral Surg
Cleft Palate-Craniofacial J. 2011;48(5):587-595. Oral Med Oral Pathol Oral Radiol. 2013;116(4):418-426.