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Case Report

A Novel Method of Obtaining Impression from

Three‑dimensionally Printed Skull and Incorporating Medical
Grade Silicone Elastomer in Fabricating Silicone Palatal
Feeding Obturators for Cleft Lip and Palate Cases
Nafij Bin Jamayet1, Ahmed Mushfiqur Rahman1, Md Minhaz Ul Islam Nizami1, Wael Ahmed Bayomy Mohamed2, Mohammad Khursheed Alam3
1
Maxillofacial Prosthetics, Prosthodontic Unit, 2Paediatric Unit, School of Dental Sciences, Universiti Sains Malaysia, Kota Bharu, Kelantan, Malaysia,
3
Department of Orthodontic, College of Dentistry, Aljouf University, Sakaka, Saudi Arabia

Abstract
This report aims to depict a novel method in impression taking and feeding obturator fabrication for cleft lip and palate patients, utilizing
three‑dimensionally printed base of the skull from presurgical computerized tomography scan data. This technique uses soft and biocompatible
medical grade room temperature vulcanizing silicone elastomer as the material of choice for fabrication procedure and reviews a representative
patient case of a 10‑month‑old female child with bilateral cleft lip and palate deformity. Before final insertion, a strap was attached to the obturator
as a safety precaution in case of accidental swallowing. The use of this unique technique satisfies all benefits of conventional feeding obturator
with the added benefits of reducing most of its discomfort and difficulties of direct impression taking from the infant and fabricating process.

Keywords: Three‑dimensional printing, cleft lip and palate, computed tomography–scan, feeding obturator, silicone

Introduction Case Report

Feeding obturator or nasoalveolar molding (NAM) is a
prosthetic aid that is designed to obturate the cleft and
restore the separation between the oral and nasal cavities.
NAM facilitates in feeding, reduces nasal regurgitation,
helps in the development of the jaws, and aids in speech,
eliminating few of the many unfortunate difficulties
of neonates and infants born with cleft lip and palate
deformity.[1]
However, a major concern with NAM is obtaining a good
preliminary impression that leads to ill‑fitting of the finished
prosthesis. Furthermore, reluctance of infants wearing the
obturator due to discomfort of the material and design of
the prosthesis still remains.[2,3] In an attempt to improve the
fitting and reduce the discomfort level of the prostheses, a
novel and a completely alternative approach has been taken
in this case to fabricate a feeding palatal obturator for a
10‑month‑old child using the currently available silicone
elastomer.
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DOI:
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The patient was a 10‑month‑old female child brought by her
parents with a chief complaint of feeding difficulties and other
complications associated with congenital bilateral cleft lip
and palate deformity [Figure 1a and b]. Intraoral examination
showed missing primitive primary palate.
Procedure
• At first, a three‑dimensional (3D) model of base of the
skull of the patient was printed from her computerized
tomography (CT) scan data [Figure 2a]. The patient
was scanned using the Siemens Somatom Definition
AS+ 128‑slice (Siemens, Erlangen, Germany) at the
Address for correspondence: Dr. Nafij Bin Jamayet,
School of Dental Sciences, Health Campus, Universiti Sains Malaysia,
Kubang Kerian, Kota Bharu 16150, Kelantan, Malaysia.
E‑mail: dr.nafij@gmail.com
This is an open access article distributed under the terms of the Creative Commons
Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows others to remix, tweak,
and build upon the work non‑commercially, as long as the author is credited and the
new creations are licensed under the identical terms.
For reprints contact: reprints@medknow.com
How to cite this article: Jamayet NB, Rahman AM, Nizami MI,
Mohamed WA, Alam MK. A novel method of obtaining impression from
three-dimensionally printed skull and incorporating medical grade silicone
elastomer in fabricating silicone palatal feeding obturators for cleft lip and
palate cases. J Int Oral Health 2018;10:40-3.

40 © 2018 Journal of International Oral Health | Published by Wolters Kluwer - Medknow

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Jamayet, et al.: Obtaining impression from 3D‑printed skull and incorporating medical grade silicone elastomer for feeding obturator

Radiology Department, Hospital Universiti Sains • Before the final insertion of the silicone palatal obturator, a
Malaysia. The CT images were analyzed and processed strap was connected to the prosthesis as a safety precaution
using Mimics Software version 18 (Materialise NV, in case of accidental swallowing [Figure 4c]. This was
Belgium). The 3D model of the base of the skull was only a precaution as the facial growth of the baby may
constructed to mimic the patient’s base of the skull for interfere with fitting in the future. However, the parents
designing the feeding obturator. The cropped virtual 3D reported that the adaptation of the prosthesis seemed very
model was later saved in stereolithography STL format, good not only at the moment but also after 2 weeks and
was sent to a 3D printer (Objet350 Connex, Stratasys, 1 month follow‑up.
USA), and was then printed using transparent rigid Vero
clear material (Stratasys, USA) Discussion
• Wax adaptation was done on the 3D‑printed model using
There have been numerous techniques documented
modeling wax (Tiranti, UK) mimicking the soft tissue in
over time to improve the fabrication process of feeding
the mouth, and the nasal cavity was blocked using putty
obturators. Unfortunately, none have successfully
material to keep the minimum undercut necessary for
addressed the problems of the impression taking procedure.
retention of the silicone palatal obturator [Figure 2a]
Preliminary impression taking becomes extremely
• Impression was then taken with special tray made from
challenging considering the age group of patients along
self‑cure acrylic resin (Fastray, Keystone Industries, NJ,
with the impending risk of aspiration and swallowing of
USA) using light and regular body polyvinyl siloxane
impression material. Clinicians have proposed specially
material (Chromaclone, Ultradent Products, Inc., South
designed impression tray, inverted posture of infants, and
Jordan, Utah, USA) [Figure 2b and c]. The special tray
impression materials having various consistencies to ensure
was constructed from the primary cast made from initial
good detail duplication required for satisfactory fabrication
impression of the 3D‑printed model
of palatal prostheses.[3‑5] Despite all efforts, the agitation
• Working cast was fabricated using type  IV dental
and nervousness of infants still remain a major factor that
stone (Glastone, Dentsply Intl., USA) [Figure 3a]. Wax
no technique has yet subdued.
design was performed on the working cast for the pattern
of the prosthesis [Figure 3b] However, use of CT scan and 3D‑printed models in this
• After the wax design was complete, separating medium current technique is a huge innovation in eliminating the
was applied on the working cast. Boxing wax was then above‑mentioned problem. The presurgical evaluation CT scan
adapted along the periphery of the working cast, and for the corrective surgery has been utilized in this case to print
type IV dental stone was poured in it to fabricate a a 3D model of base of the skull.   The preliminary impression
two‑piece mold [Figure 3c and d] of the defect has been taken from this model after certain wax
• Room temperature vulcanizing silicone A‑2000 adaptation, thus avoiding the direct impression taking of the
(Factor II Inc., Lakeside, AZ, USA) was dispensed uncooperative infants.  This completely alternative impression
according to the manufacturer’s instructions in a mixing taking allows minute details to be reproduced including the
pad without adding any opacifier and pigments valuable undercuts in minimum time so important for retention
• The mixed silicone was then packed into the upper and of the obturator and saves ample time of the clinician and
lower halves of the stone mold [Figure 3d]
• After complete polymerization, the two halves of the mold
were separated and the prosthesis was detached from the
mold
• The excess flash was trimmed and finished according to
try‑in on the working cast. Slight adjustments had to be done
during final insertion of the prosthesis [Figure 4a and b]

a b

c
a b Figure 2: Impression taking (a) modification done on three‑dimensional
Figure 1: Patient profile (a) frontal facial view, (b) intraoral view of the printed model using wax and putty material, (b) impression taking of the
defect defect from three‑dimensional printed model, (c) impression of the defect

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Jamayet, et al.: Obtaining impression from 3D‑printed skull and incorporating medical grade silicone elastomer for feeding obturator
a b
c d
Figure 3: Wax design for prosthesis and Silicone loading (a) working
cast, (b) wax design on working cast for prosthesis, (c) lower half of
two‑part mold, (d) silicone loading on upper half
parents compared to conventional and slightly modified
impression techniques.[6‑8]
Another vital difference in this fabricating technique is the
use of silicone materials. Conventionally, acrylic has been
the material of choice in spite of its chance of irritating
the oral mucosal or gingival tissue. The molding plate
of the obturator needs to be relieved in all areas that exerts
excessive pressure.[4,6,8] All such risks can be avoided with
the use of silicone with its soft consistency and excellent
biocompatibility . Moreover, all modifications needed to be
done on the prosthesis can be performed in the laboratory and
tried in the printed model, thus sparing  the repeated visits to
the clinic. After all adjustments, the patient is called in for the
final insertion of the finished palatal obturator.
The unique impression technique used in this case is not
only accurate in producing minute details of the defect
that is highly difficult from direct impression in infants but
also less risky and time‑consuming considering the fact of
aspiration of impression materials, for which additional safety
team and oxygen support are needed.[9] The use of medical
grade silicone for actual fabrication of obturator makes
the prosthesis even more effective as it overcomes the oral
mucosal irritation and excessive pressure of conventionally
used materials.[4,6,8]
This technique would be more rapid if 3D printer could have
been used for printing of the prosthesis as well. Unfortunately,
this is not possible yet as the current materials available for 3D
printing are not as biocompatible and soft as silicone materials.
Even if such materials were available that would have required
specialist in craniofacial morphology and software engineering
to design and formulate the impression tray, mold, or the
prosthesis itself.[9,10] However, this method does not need such
technical support. Only CT scan data are required to print the
3D base of the skull from a 3D printer either present in the
same hospital or any nearby institution.
42 Journal of International Oral Health  ¦  Volume 10  ¦  Issue 1  ¦  January‑February 2018
a b
c
Figure 4: Final insertion (a) insertion of prosthesis, (b) final prosthesis
in place, (c) incorporation of strap for safety precaution
Despite these techniques’ many advantages, it poses one
difficulty. The 3D model printed from the CT scan data
represents only hard tissues. However, the prosthesis will be
inserted on soft tissues overlying hard tissues in the mouth.
In effort to overcome this problem, threshold level of CT scan
data saved in digital imaging and communication in medicine
file format was enhanced which gave a minimum image of
the soft tissue, and wax adaptation was done on 3D‑printed
base of the skull to simulate soft tissues adding an extra step
in the fabricating process.
Despite the aforementioned modifications performed
on this case to mimic the surrounding soft tissues of the
mouth, it was not possible to achieve an exact simulation
of the soft tissues. Therefore, there could have been issues
regarding inadequate retention and disproportionate pressure
on the fitting surface. However, accurate wax adaptation
minimized the effect and a satisfactory retentive palatal
feeding obturator was achieved. Even though a satisfactory
palatal feeding obturator was fabricated, researches should
be done to eliminate this soft tissue problem. The feeding
obturator would be much more accurate and beneficial if
the soft tissue information can be incorporated during the
analysis and processing of the CT images in the Mimics
software. The integration of the soft tissue thickness with
the hard tissue information of the CT image   would mean
a 3D‑printed model with a combined thickness of soft and
hard tissue of the mouth, thus leading to the elimination of
the wax adaptation stage and fabrication of an accurate  and
most retentive feeding obturator in the future.
Conclusion
This article describes an entirely novel and alternative
method for impression taking and fabrication of feeding
obturators for cleft lip and palate patients. The use of this
unique technique satisfies all the benefits of a conventional
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Jamayet, et al.: Obtaining impression from 3D‑printed skull and incorporating medical grade silicone elastomer for feeding obturator

feeding obturator with the added benefits of reducing most References

of its usage discomfort and difficulties of impression and
fabricating process.
Acknowledgment
This case study has been supported by Universiti Sains
Malaysia (USM) short‑term grant no: 304/PPSG/61313144.
Declaration of patient consent
The authors certify that they have obtained all appropriate
patient consent forms. In the form, the patient’s parents
have given their consent for her images and other clinical
information to be reported in the journal. The patient’s parents
understand that name and initials will not be published and
due efforts will be made to conceal identity, but anonymity
cannot be guaranteed.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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