Clinical/Case Report

The Cleft Palate-Craniofacial Journal

1-10
OrthoAligner “NAM”: A Case Series ª 2019, American Cleft Palate-
Craniofacial Association

of Presurgical Infant Orthopedics (PSIO) Article reuse guidelines:

sagepub.com/journals-permissions
DOI: 10.1177/1055665619889807
Using Clear Aligners journals.sagepub.com/home/cpc

Puneet Batra, BDS, MDS1, Bruno Frazāo Gribel, DDS, MSc2,

B. A. Abhinav, BDS1, Anika Arora, BDS, MDS1,
and Sreevatsan Raghavan, BDS, MDS1

Abstract
Presurgical infant orthopedics (PSIO) is done to reduce the size of the cleft defect along with improving the arch alignment and
nasolabial aesthetics in patients with cleft lip and palate, leading to an improvement of nasolabial aesthetics allowing for a tidier
and more aesthetic reparative procedure and postsurgical scar. Since the 2000s, clear aligners have slowly and steadily treaded
their way as an acceptable orthodontic modality, with their usage and acceptability increasing considerably over the past decade.
Thus, from the knowledge gathered in its 10 years working with 3-dimensional (3-D) diagnosis, treatment planning, and 3-D
Printing services, Compass 3D (Belo Horizonte, Brazil) developed the OrthoAligner NAM system. This case series highlights one
of the world’s first documented cases of PSIO treated with a series of clear aligners.

Keywords
orthodontics, infant orthopedics, dental arch

Introduction
The concept of presurgical infant orthopedics (PSIO) for
patients with cleft lip and palate began to gain popularity in
the 1950s; later validated by the findings of Matsuo (1988)
when he recognized that the newborn cartilage is soft and lacks
elasticity; thus can be easily molded. Matsuo postulated that
high level of estrogen during parturition correlated with
increased levels of hyaluronic acid, inhibiting the linkage of
the intercellular cartilage matrix permitted the molding of the
facial cartilages. The level of estrogen begins to decline within
4 months after birth; therefore, it is advisable to start PSIO
during this early period (birth to 4 months; Matsuo et al.,
1989; Matsuo & Hirose, 1991).
From Hoffman (Millard, 1977) in the 1600s to Brophy
(1927), the concept and application of PSIO in patients with
cleft lip and palate has evolved with time. Serial molding
through plates was originally performed by McNeil (1950) and
was later popularized by Burston (1958). This technique also
underwent a series of modifications, which included active
molding given by the likes of Georgiade and Latham (1975);
however, these active plates and techniques were found to have
a detrimental growth effect on the already compromised
maxilla (Millard, 1980; Hotz et al., 1987). Grayson (1993)
introduced the technique widely used world over today describ-
ing it as presurgical nasolaveolar molding that involved passive
molding simultaneously repositioning the deformed nasal car-
tilages and alveolar processes as well as the lengthening of the
deficient columella. The Grayson technique has also been
extensively modified and reinvented with an aim toward better
outcomes and ease of comfort for the infant patient and their
respective caregivers (Figueroa et al., 1996; Monasterio et al.,
2013; Vinson, 2017). Clear orthodontic appliances were intro-
duced by Kesling (1946), progressively moving misaligned
teeth to improved positions. It wasn’t until 1997 that Align
Technology (Santa Clara, California) introduced the clear
aligner treatment (CAT) as we know it today. Although CAT
1
Department of Orthodontics and Dentofacial Orthopedics, Institute of
Dental Studies and Technologies, Kadrabad, Modinagar, Uttar Pradesh, India
2
Compass 3D: Inteligēncia e Tecnologia para dentistas, Funcionários, Belo
Horizonte, Minas Gerais, Brazil
Corresponding Author:
Sreevatsan Raghavan, Department of Orthodontics and Dentofacial
Orthopedics, Institute of Dental Studies and Technologies, Kadrabad,
Modinagar, Uttar Pradesh 201201, India.
Email: sreevatsanr32@gmail.com
2 The Cleft Palate-Craniofacial Journal XX(X)
treatment acceptability has considerably increased over the
years especially for adult patients (Krieger et al., 2012), it has
still not found its way into more pediatric or infant modes of
dentofacial orthopedics and orthodontics. Given the advent of
technological improvements like intraoral 3-dimensional (3-D)
scanning and a recent successful documentation of the same in
a patient with bilateral cleft (Patel et al., 2019), the prospect of
PSIO using CAT was an interesting option, especially with
regard to comfort and ease of use, as the hazards of impression
taking in cleft babies like respiratory obstruction and cyanosis
is well documented in the literature (Chate, 1995). This case
series discusses treatment of patients using a series of clear
aligner plates for alveolar molding used in conjunction with a
nasal elevator for nasal molding where in all cases 15 aligner
sets were designed using a digital workflow to reduce the cleft
defect prior to lip surgery.
Case 1
A 7-day-old male patient was referred to the department cleft
clinic with a unilateral cleft lip and palate (UCLP) on the left
side. On clinical examination, a cleft gap of 14 mm at lip level
and 12 mm at the alveolar ridge level was observed. The ala
and columella of the nose were collapsed on the left side with a
columellar deviation angle of 30 . A total nostril width of 22
mm and a nostril height of 2 mm were recorded. The nasal
septum was deviated to the noncleft side by 6 mm and the nasal
base width on the cleft side was observed to be 12 mm with the
nasal dome height being 5 mm (Figure 1A).
Case 2
A 1-month-old male was referred to the clinic with a UCLP on
the left side. On clinical examination, a cleft gap of 12 mm at
lip level and 10 mm at the alveolar ridge level was found. The
ala and columella of the nose were collapsed on the left side
with a columellar deviation angle of 38 . The case presented
with a nostril width of 20 mm and a nostril height of 3 mm. The
nasal septum was deviated to the noncleft side, that is, right
side by 5 m. The nasal base width on the cleft side was 12 mm
and the nasal dome height was 5 mm (Figure 1B).
Case 3
A 1-month-old female with a UCLP on the right side was
referred to the clinic. On clinical examination, a cleft gap of
16 mm at lip level and 12 mm at the alveolar ridge level were
found. The ala and columella of the nose were collapsed on the
right side with a columellar deviation angle of 28 . The nostril
width of 25 mm and nostril height of 1 mm were noted. There
was a nasal septal deviation to the noncleft side, that is, the left
side by 7 mm. The nasal base width on the cleft side was 13 mm
and the nasal dome height was 4 mm, respectively (Figure 1C).
Case 4
A 1-month-old female was referred to the clinic with a UCLP
on the left side. On clinical examination, a soft-tissue cleft gap
of 13 mm at lip level and 12 mm at the alveolar ridge cleft were
found. The ala and columella of the nose were collapsed on the
left side with a columellar deviation angle of 20 0. The width of
the nostril was 17 mm and the height of the same was 2 mm.
The nasal septum was deviated to the noncleft side, that is, right
side by 5 mm. The nasal base width on the cleft side was 10 mm
and the nasal dome height was 3 mm (Figure 1D).
Method of Appliance Fabrication
Scanning
Intraoral scanning was done using a Trios 3-Shape scanner
using the “smaller/children” scanning tip (3Shape, Copenha-
gen, Denmark) with the help of a clinical assistant who aided in
the retraction of the lips and cheeks. The scan was performed in
the orthodontic department of a dental college. The infant was
seated in the parent’s lap and stabilized gently with the parent’s
hand on the infant’s head. The overall time taken was on aver-
age 1 minute 30 seconds to 2 minutes. Care should be taken to
gently navigate the scanner in the infant’s mouth so as to not
cause or irritate the delicate soft tissues.
Additionally, while the software is programmed to cap-
ture continuous dental arches, the discontinuous segments
may be interpreted as redundant details and surfaces; hence,
care should be taken while editing the impression before the
final processing. Although this definitely leads to a “play by
ear” situation where another scan attempt might be required,
the clinician using the scanner was quite adept at the scan-
ning and postcapture image processing exercise, and no
scans were repeated.
Virtual Setup
Following the scan, a 3-D model of the maxilla was prepared
for fabrication of the aligner plates (Figure 2A and B) using a
reference point and line grid system that was based on the
anatomic structures (Dürwald & Dannhauer, 2007; Batra
et al., 2015). The same model was imported into MESH labs
software (Institute of Information Science and Technology,
Pisa, Italy) with the intention of superimposing pre- and post-
treatment models.
Using the OrthoAnalyzer software (3Shape) with the vir-
tual base parallel to the occlusal plane and the midsagittal
plane determined according to the child’s extraoral pictures,
a virtual setup was made separating the major and minor
cleft segments and the respective dental grooves on each
cast with the desired ideal arch determined using 3 points
and a ovoid arch shape using the OrthoPlanner software
(3Shape; Figure 2D).
In order to optimize molding of this arch form, in unilat-
eral patients, most often it is required that the dental grooves
(enclosing the tooth buds) be segmented so as to not reduce
Batra et al 3

Figure 1. A-D, Pretreatment extraoral and intraoral pictures of the cases 1 to 4, respectively.

the posterior maxillary width. Additional care should be
taken in patients with bilateral cleft as they often require
greater 3-D control (roll, pitch, and yaw) of the premaxilla
that is usually projected as a result of the upward frenum
tension in that segment.
The alignment and approximation of the alveolar cleft
segments, remodeling of the major segment, passive
reduction of the alveolar gap, correction of the midlines,
and the maintenance of the lateral width of the nasoalveolar
segments were the objectives of this PSIO treatment mod-
ality. The number of stages required to gradually mold the
segments was determined based on the amount of movement
required to accomplish the desired result that did not exceed
1 mm per stage (Figure 2E).
4 The Cleft Palate-Craniofacial Journal XX(X)

Figure 2. A, Three-dimensional (3-D) scan of the maxilla done using Triose 3-Shape scanner. B, Linear variables and angular variables marked on
the 3-D image of the scanned intraoral cleft model. C, MESH labs software superimpostion showing pre (light blue) and post (yellow changes). D,
Schematic representation of the workflow in designing the treatment using CAT software. E, Sample frame by frame demonstration of the virtual
setup.

Appliance Fabrication
Once the number of stages were determined (15 in all 4 cases),
the setup was exported in STL file format to an Eden 500
(Stratasys) 3-D Printer, for manufacturing at an accuracy of
16 mm using the opaque resin MED620 (Stratasys, Rehovot,
Israel). The series of 3-D printed models acted as a mold for the
thermo-formed aligners made from triple-layer, resilient-
plastic material: OrthoAligner Ultimate (Compass 3D, Belo
Horizonte, Brazil) of 0.66 mm thickness.
Treatment Progress
The treatment was carried out over a period of 16 weeks (4
months). The aligner was changed every week to achieve the
goals of alveolar molding as stated above in incremental steps.
The parents were advised to keep the appliance in the mouth
throughout the day and night including feeding and asked to
clean the same twice in a day. The patients were recalled every
5 weeks. The parents were taught the procedure for retentive
taping and were advised to change the tapes every day or
whenever the tapes peeled off. The appliance was retained
naturally in the mouth, and while the parents were prescribed
a polydent denture adhesive, no such retention problems were
encountered with the appliance in all 4 patients.
From sixth week onward or when the size of the cleft was
reduced to 5 mm, the stage of active nasal molding was initi-
ated. This was done according to the principles of Grayson and
Maull (2004), who stated that as the alveolar gap is reduced,
there is an improvement of alignment in the base of the nose
and the adjoining lip segment. This allows the alar rim, which
was previously tense, to show some laxity to allow for the nasal
molding to take place more efficiently.
The progress of treatment of a sample case is highlighted in
Figure 3A and B, respectively. A nasal elevator from the Dyna-
cleft system (Monasterio et al., 2013) was used in increasing
the columella length and nasal molding (Figure 3B).
In addition to cast-based measurement based on the vir-
tual models, extraoral photographs were taken using a
custom-made box with a millimeter scale fitted to prevent
magnification errors. The infant’s head was stabilized using
a head pillow along with the assistant’s hands, which was
maintained for a 1 minute before the photograph was
Batra et al 5

Figure 3. A, Weekly progress of case no. 1 wearing sequential aligners. B, Sixth week: Patient with the nasal elevator and aligner in place
intraorally.

captured. The millimeter scale helped in the calibration of Treatment Results

the image in Adobe Photoshop CS6 (Adobe Inc, San Jose, Total treatment time taken was 16 weeks. There was either
California), where linear and angular measurements were complete or near-complete approximation of the ridges, close
performed for the nostril height and width, columellar to desirable nasal conformity and significant increase in the
deviation angle, and the soft-tissue cleft gap. columella length was observed in all the cases (Figure 4A-D).
6 The Cleft Palate-Craniofacial Journal XX(X)

Figure 4. A-D, Following presurgical infant orthopedics extraoral and intraoral pictures of the cases 1 to 4, respectively.

An intraoral scan was performed after the PSIO procedure using
similar technique and precautions and the maxillary sections
showed considerable improved with respect to reduction in cleft
gap in all the cases. As stated above, a superimposition was
performed using MESH labs software (Institute of Information
Science and Technology)—GOM Inspect. The computed poly-
gon surfaces of the pre- and post-treatment casts are read as
freeform surfaces and standard geometries in this software.
These casts were then superimposed using a 3-D difference
analysis function, which highlighted improvements in the
alveolar ridge when viewed from the occlusal, left, and right
buccal aspect (Figure 2C).
Table 1 highlights the statistically significant improvements
in the cast and photographic parameters after PSIO therapy after
using the paired t test. There was linear, transverse, and sagittal
reduction in the alveolar cleft gap, which was statistically sig-
nificant (P < .05), while maintaining the posterior width of the
maxillary segments, which did not show any statistically signif-
icant change. There was an improvement in the arch form due to
the passive inward and approximating molding vector of the
 Table 1. Pre- and Post-PSIO Comparison of Cast-Based and Photographic Parameters Using Paired t Test.

Pre Post Mean Standard Standard Error 95% Confidence Interval Sigma
Cast Measurements (Mean + SD) (Mean + SD) Difference Deviation of the Mean of the Difference (2-Tailed)
Linear variables (mm) Lower Upper
PL-PS 30.5 + 3.5 31.88 + 2.47 1.358 5.140 1.817 5.656 2.939 .476
BL-BS 33.79 + 1.12 33.41 + 1.44 0.381 0.609 0.215 0.129 0.890 .121
Transverse AL-AS 10.5 + 2.7 3.5 + 1.9 7.000 1.789 0.730 5.123 8.877 .000
Sagittal AL-AS 9.33 + 3.2 3.83 + 3.6 5.500 1.517 0.619 3.908 7.092 .000
AL-AS 10.17 + 2.8 3.17 + 2 7.000 2.098 0.856 4.799 9.201 .000
ML-(PL-PS) 26.67 + 4 23.83 + 4.2 2.833 2.317 0.946 0.402 5.264 .030
MS-(PL-PS) 22.50 + 4.0 18.17 + 2.4 4.333 2.066 0.843 6.501 2.166 .004
Angular variables (o)
(AL-PL)-(PL-PS) 58.77 + 1.48 49.31 + 1.13 9.462 3.986 1.409 6.130 12.794 .000
(AS-PS)-(PL-PS) 63.9 + 1.8 53.44 + 1.8 10.518 7.408 2.619 4.325 16.712 .005
AL-BL-PL 115.03 + 3.7 108.98 + 3.4 6.046 3.606 1.613 10.523 1.568 .020
AS-BS-PS 124.13 + 2.46 114.5 + 1.85 9.629 2.421 0.856 7.605 11.653 .080
(BL-AL)-(BS-AS) 122.69 + 6.3 138.62 + 13.2 15.934 10.929 4.888 29.504 2.364 .031
Pre Post Standard Standard Error 95% Confidence Interval Sigma
o)
Extraoral Photographic (mm and (Mean + SD) (Mean + SD) Deviation of the Mean of the Difference (2-Tailed)
Lower Upper
Columellar deviation angle 39o + 7.8o 76.83o + 16.3o 14.784 6.036 53.348 22.318 .002
Nostril width 18.67 + 3.4 8.50 + 1.7 4.070 1.662 5.895 14.438 .002
Nostril height 1.67 + 0.51 6.5 + 1.2 1.472 0.601 6.378 3.289 .000
Soft-tissue cleft gap 14.83 + 4.6 5.78 + 0.74 4.793 1.957 4.020 14.080 .006

Vertical (mm), Major Segment Minor Segment

Posttreatment Description (Median) (Median) Sigma

Horizontal Superimposition performed 0 1 .635

reference line to check for any
vertical discrepancy

Abbreviations: PSIO, presurgical infant orthopedics; SD, standard deviation.

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

Figure 5. A-E, Postsurgical picture of cases 1 to 4, respectively (A-D); (E) postsurgical worm’s eye view of case 1.

appliance. After the completion of our molding, the patient was
referred for lip surgery, where due to the successful completion
of PSIO, a good surgical result was obtained (Figure 5A-E). As
secondary alveolar bone graft is performed at this center during
the mixed dentition stage, no gingivoperioplasty was performed
during the lip repair procedure.
Discussion
Presurgical infant orthopedics creates the foundation upon
which excellent results of primary lip and nasal surgery are
dependent on which this case demonstrates as well. This case
series highlights, in our humble opinion, one of the world’s first
documented PSIO cases treated with CAT based on the search
Batra et al
on PubMed and Medline. The use of an intraoral scanner for
recording details in patients with cleft lip and palate has been
on the rise and it has been shown to be less hazardous, more
comfortable, and more accurate when compared to intraoral
impressions in patients with cleft (Chalmers et al., 2016; Patel
et al., 2019). The scanning speed of up to 3000 images per
second nearly nullifies the influence of any movement between
the scanning tip and the surrounding oral structures. This
allows for a proper recording of the tissues to be obtained
without the chance of symmetry error, a fact which was
recently highlighted (Patel et al., 2019).
The use of clear aligners also simplify the molding process
as the lab procedures (addition of soft liner, selective trimming)
involved in the Grayson technique are eliminated; this makes
the overall process more convenient for the patient and the
caregiver as multiple visits for lab adjustments are eliminated.
In this study, the patients only had to visit thrice to the center,
which is a considerable reduction. Additionally, the compli-
cations of an acrylic plate–like pressure ulcers, laceration, and
so on are also eliminated; thereby making the process more
comfortable for patients. No such adverse events or compli-
cations were reported with any of the patients during the
course of therapy.
It is noteworthy to mention that Matsuo (1989) immediately
began with the nasal molding process, using a stent in the form
of a pair of silicone tube. He did so without alveolar molding,
leading to some limitations. These included the need for an
intact nasal floor and the inability to direct the force because
the stent that was used expanded circumferentially, causing the
nasal molding to happen as well as planned.
This case series shows potentially a small step toward an
exciting future of PSIO using CAT. Since several aligner com-
panies now 3-D print their aligners, it is also interesting to see if
any bioreactive materials can be printed as aligner tray to
invoke a better biological response (Batra, 2018). Further-
more, the option of directly printing a nasal elevator into the
tray would also simplify the overall treatment program.
Lastly to conclude, a comparative study should be under-
taken to compare the PSIO using CAT with other accepted
methods like the Grayson’s technique, Dynacleft system, and
so on. This logical marriage of technology and treatment
could yield very promising results along with increasing the
comfort and convenience of the patients. While the addi-
tional cost of burden is to be considered as CAT is not as
economical as other PSIO procedures, in this case no such
extra burden was encountered as the treatment was funded by
a charity organization.
Acknowledgment
The authors would like to thank Smile Train for facilitating and coor-
dinating the interactions and knowledge sharing between the authors
at the early stages of execution of this subject matter.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to
the research, authorship, and/or publication of this article.
9
Funding
The author(s) received no financial support for the research, author-
ship, and/or publication of this article.
ORCID iD
Sreevatsan Raghavan, BDS, MDS https://orcid.org/0000-0003-
3031-8469
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