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Clinical Article
Nasal Changes With Nasoalveolar Molding in Colombian Patients With Unilateral Cleft Lip
and Palate
Ana María López-Palacio, DDS, Cert Ped Dent1 • Ana María Cerón-Zapata, DDS, Cert Ped Dent2 • David F. Gómez, DDS, Cert Ortho, MS3 •
Ángela P. Dávila-Calle, DDS, Cert Ped Dent4 • María Adelaida Ojalvo-Arias, DDS, Cert Ped Dent5
Abstract: Purpose: Presurgical nasoalveolar molding (PNAM) is controversial in maxillofacial orthopedics. It supposedly improves the nasal esthetics and
function in unilateral cleft lip/palate (UCLP) patients. However, there is no research available in South America to support this claim. The purpose of
this study was to evaluate the efficacy of presurgical nasoalveolar molding therapy on morphological changes of the noses of unilateral cleft lip/palate
patients in a Colombian sample. Methods: Seventeen neonate UCLP patients using PNAM received facial impressions at the beginning of treatment; before
primary rhinocheiloplasty; and before palatoplasty. A submentovertex photograph of each cast was taken and analyzed by digital photogrammetry.
Wilcoxon and Friedman tests were used for within- and between-group comparisons. Results: A statistically significant reduction of cleft nostril width,
without significant changes in noncleft nostril width or total nasal width, was found after PNAM. A significant increase in cleft and noncleft nostril height,
plus a nonsignificant increase in nostril area in both sides and a nonsignificant uprighting of the columella were found. These changes were maintained or
further improved after rhinocheiloplasty. Conclusion: The presurgical nasoalveolar molding technique improved nasal tip projection and alar cartilage
depression and decreased partially columella deviation before rhinocheiloplasty in South American unilateral cleft lip/palate patients. (Pediatr Dent 2012;
34:) Received August 3, 2010 | Last Revision May 25, 2011 | Accepted June 5, 2011
KEYWORDS: UNILATERAL CLEFT LIP AND PALATE, PRESURGICAL NASOALVEOLAR MOLDING, PRIMARY RHINOCHEILOPLASTY, PRESURGICAL CLEFT APPLIANCE
Cleft lip and palate (CLP) is a congenital craniofacial anomaly inclined, and the base is deviated toward the noncleft side
produced by embryological defects during formation of the (Figure 1).5,8 These characteristics have a psychological influence
face. It is considered the most frequent developmental ano- on the patients and their families, generating low self-esteem,
maly of the face.1 The prevalence of cleft lip and palate is 1 in low value of their self-image, and difficulties in their social
500 to 1 in 2,000, depending on the population affected development.9
(1:1,000 in Caucasians, 2.1:1,000 in Japanese, and 0.5:1,000 The nasal cartilages, columella, philtrum, and alveolar seg-
in African Americans). Of these patients, 76% present unilateral ments should be aligned and adequately reconfigured to faci-
clefts and 24% present bilateral clefts.1,2 In Colombia, the prev- litate surgical repair of the cleft area. To obtain this objective,
alence of this anomaly is 1 in 500 to 1 in 1,000, depending Grayson et al. proposed the use of presurgical nasoalveolar
on the geographic zone and the socioeconomic standard of molding (PNAM), an orthopedic device that aligns alveolar
the population.3 ridges intraorally and improves malposition of nasal cartilages
Unilateral cleft lip and palate (UCLP) patients have an es- extraorally. In UCLP patients, PNAM repositions the philtrum
thetic and functional compromise of the middle third of the and columella via nasal extension.5,8,10,11 Several techniques of
face primarily involving nasal structures.4 The UCLP noses are labial adhesion with adhesive tape can be used additionally to
deformed in the 3 planes of space.5,6 This deformity is caused by this procedure to approximate the labial cleft segments, thus
the distortion and displacement of the nasal structures.7 The reducing tension in surrounding tissues and facilitating surgical
alar cartilage on the cleft side is depressed and concave, which intervention. The tape helps to close the defect by diminishing
results in depression and displacement of the nasal tip toward the nasal base width, moving the columella to the midsagittal
the side of the cleft. The columella and the nasal septum are plane, improving the symmetry of both nostrils, and approxi-
mating the labial segments.5,8,12 Presurgical nasoalveolar mold-
ing appliances and labial adhesion with tape decrease the size
of the cleft in order to perform surgery of the nasolabial complex
1 Dr. López-Palacio is an associate professor, Department of Basic Integrated Studies, in coordination with the alveolar deformity.8
College of Dentistry, University of Antioquia; 2Dr. Cerón-Zapata is an associate pro- The use of PNAM and labial tapping in patients with
fessor, Department of Basic Integrated Studies, College of Dentistry, University of Antio- UCLP is a controversial subject in developing countries regard-
quia and Instructor, Graduate Program in Pediatric Dentistry, College of Dentistry, CES ing the therapeutic benefits vs time and costs involved. A
University; 3Dr. Gomez is an assistant professor, Graduate Program in Orthodontics,
College of Dentistry, CES University, and the Department of Basic Integrated Studies,
modified PNAM technique has been used at the Fundación
College of Dentistry, University of Antioquia; 4Drs. Dávila-Calle and 5Ojalvo-Arias are Clínica Noel (FCN), Medellin, Colombia, over the last decade.
in private practice, all in Medellín, Colombia, South America. The soft tissue response to this type of therapy, however, has
Correspond with Dr. López-Palacio at anamarialopez@une.net.co not been evaluated systematically.
National Institutes of Health. The linear, angular, and Table 2. LANDMARKS AND LINEAR, ANGULAR, AND AREA MEASUREMENTS USED IN
area measurements were evaluated on the cleft side THIS STUDY*
and compared to the noncleft side. The measurements Landmarks
obtained with this methodology permitted the eval-
Pronasal (prn) Most protruded point of the nose
uation of the tissue response after each stage of the
Subnasal (sn) Midpoint formed where the lower
therapy of PNAM and after primary lip surgery border of the nasal septum and the
(Table 2). surface of the upper lip meet
A pilot study to calibrate intra- and interexaminer Subnasal’ (sn’) Columella base toward the inner
side of the nostril
error was conducted. The results showed that the intra- Subalare (sbal) Labial insertion of the alar base
examiner error was 0.39 mm maximum for the linear Alar curvature (ac) Facial insertion of the alar base
measurements, 1.12 mm 2 for the area measurements, Columella’ (c) Most superior point on the colu-
and 1.41º for the angular measurements. For the inter- mella crest
examiner error, the results were 0.34 mm for the linear Linear measurements
measurements, 1.15 mm 2 for the area measurements, 1. Width of the nasal Width between the facial insertion
and 3.31º for the angular measurements. base (Ac-Ac) points of the alar base
Statistical analysis. The Shapiro-Wilk test was 2. Height of the nostril Distance between c’ passing through
(HN)(C-NC) the subalar-subnasal’ plane
used for all variables to establish sample distribution.
3. Width of the nostril Distance between subnasal’ and
Test results showed that the sample did not fall into a (WN)(C-NC) subalar points.
normal distribution; therefore, nonparametric statistical
Angular measurements
tests were used. The Friedman test was used to compare
the differences among the T1, T2, and T3 medians, 4. Inclination of the Angular measurement between
columella (Cl) pronasal-subnasal plane and
and the Wilcoxon test were used to test for differences subalare-subalare plane.
between T1-T2, T1-T3, and T2-T3. The level of sta- Area measurement
tistical significance was .05. For the variables in which
5. Area of the nostril Area covering the open space inside
both nostrils were studied, the value corresponding to (AN) (C-NC) the nostril; in the cleft side, it refers
the difference between the cleft nostril vs the noncleft to the area existing over a plane
was used. To determine the percentage of improve- between the subalare and the inter-
section of the vestibule line, with
ment due to the use of PNAM combined with growth the center of the maxillary alveolar
from the overall nasal results (PNAM + surgery + process in the lateral view
growth), a ratio between PNAM + growth : overall re-
sult was obtained for all variables studied. *After Farkas et al., 1992; Farkas et al., 1993.
Table 3. NONPARAMETRIC STATISTICAL ANALYSIS OF NASAL MORPHOLOGY MEASUREMENTS USED IN THE PRESENT STUDY
Measurement Beginning of treatment Before primary Before palatoplasty Friedman Wilcoxon %
rhinocheiloplasty
Median Range Median Range Median Range T1**-T2 T2†-T3 T1-T3 § PNAM +
growth at T3
Width of nose Width of nasal 28, 76 25, 34-34, 70 28, 78 22, 49-33, 86 28, 72 25, 61-32, 89 NS* NS NS NS NS
(mm) base
Nostril width Width of nostril 14, 21 10, 13-18, 64 12, 61 10, 89-15, 28 9, 75 7, 26-11, 95 0.000 0.017 0.000 0.000 35.87
cleft (mm) (cleft)
Nostril width Width of nostril 5, 96 3, 57-8, 15 5, 61 2, 50-7, 39 7, 04 4, 76-8, 53 0.000 NS 0.000 0.000 -32.40
noncleft (mm) (cleft)
Nostril width Width of nostril 8, 89 1, 98-12, 78 7, 62 5, 31-9, 29 2, 81 0, 50-6, 53 0.000 NS 0.000 0.000 20, 88
difference cleft- difference
noncleft (mm)
Nostril height Height of nostril 1, 63 0, 71-2, 83 2, 20 0, 97-4, 13 2, 65 1, 15-4, 61 0.005 0.039 NS 0.003 55, 88
cleft (mm) (cleft)
Nostril height Height of nostril 2, 41 1, 33-3, 28 3, 12 1, 92-4, 22 3, 03 1, 37-5, 39 0.011 0.005 NS 0.028 114.5
noncleft (mm) (noncleft)
Nostril height Height of nostril (-)0, 69 (-)1, 80 - (-)0, (-)0, 69 (-)2, 09-0, 91 (-)0, 54 (-)1, 51-1, 40 NS NS NS NS NS
difference cleft- difference 03
noncleft (mm)
Columella Inclination of 73, 78 62, 67-87, 97 76, 34 64, 74-86, 88 88, 07 73, 26-94, 24 0.005 NS 0.002 0.004 17, 91
inclination columella
(degrees)
Nostril area Area of nostril 35, 7 18, 60-47, 26 34, 81 18, 73-63, 81 29, 59 13, 93-58, 90 NS NS NS NS 14.57
cleft (mm2) (cleft)
Nostril area Area of nostril 22, 19 10, 03-33, 15 22, 34 14, 92-41, 83 31, 28 22, 17-55, 48 0.000 NS 0.013 0.001 1.65
noncleft (mm2) (noncleft)
Nostril area Area of nostril 11, 05 (-)2, 15-26, 76 7, 8 (-)6, 28-28, 79 (-)1, 31 (-)21, 99-25, 38 0, 001 NS 0, 001 0, 007 26, 29
difference cleft- difference
noncleft (mm2)
*NS=nonsignificant. * * T1 = Before PNAM; †T2 = After PNAM; §T3= After primary rhinocheiloplasty.
Results -5.22 mm2; a ~85% decrease), while the noncleft nostril area
The age at the beginning of treatment (median) was 26 days. remained essentially unchanged after PNAM (median: 0.15
The average time of use of the appliance was 3½ months mm2; a ~2% increase) and increased by a median of 8.94 mm2
before the primary rhinocheiloplasty. All data regarding the (a ~98% increase) after primary nasal and lip repair. A statis-
ages when T1, T2, and T3 facial impressions where taken tically significant decrease was found when analyzing the dif-
appears in Table 1. No nasal changes obtained after palato- ferences between cleft and noncleft side’s medians for this
plasty were assessed in the present study. measurement at the 3 time points. Only T2-T3 and T1-T3
The nose’s width median did not show statistically signifi- differences, however, demonstrated a statistically significant
cant differences in the 3 time points of evaluation (Table 3, decrease (~26% decrease after PNAM; ~74% decrease after
Figure 3a). The median values for nostril width on the cleft rhinocheiloplasty; Table 3, Figure 3e).
side significantly decreased 4.4 mm. A significant decrease
(median: 1.6 mm; 36% of total change) corresponded to the Discussion
PNAM protocol used, which was followed by an even higher The technique of presurgical nasoalveolar molding is used to
significant decrease after surgery (median: 2.8 mm; 64% of correct nasal deformity, approximate alveolar segments, and im-
total change). The same measurement in the noncleft side dem- prove labial position in patients with UCLP. This procedure
onstrated a decrease after PNAM (median: -0.35 mm; ~32% permits the anatomical correction of the nasoalveolar structures
decrease from total change) that was followed by a recovery and facilitates surgical repair of the lip and the nose with mini-
of normal growth afterward (median: +1.43 mm; ~132% mum tension. At the same time, the use of adhesive tape over
increase to reach total change). This effect of the behavior the lip improves the conditions of healing after primary lip and
of the 2 measurements explains why the difference in the nose repair (rhinocheiloplasty) by limiting the stretching of
width of the nostril (subalar to subnasal) of the cleft vs tissues, further favoring tissue recovery. This, in turn, benefits
the noncleft sides showed a progressive reduction along the the esthetic results after rhinocheiloplasty and prior palato-
evaluation periods, which was only statistically significant plasty.8 PNAM creates a nasal floor by the intraoral acrylic plate,
between T2 and T3 (Table 3, Figure 3b). and the repeated adjustments made in the alveolar and nasal
The median values for nostril height on the cleft side in- portions throughout the time the appliance is used help to
creased 1.02 mm, with a 0.57 mm (~56%) increase corre- obtain the desired nasal and alveolar molding results (Figure 4).
sponding to PNAM treatment. The same median values on In the present study, no significant statistical results were
the noncleft side demonstrated a 0.71 mm (~115%) increase found in the evaluation of the PNAM intervention at the
after PNAM, followed by a slight decrease after rhinochei- width of the nasal base. Farkas et al., compared the changes in
loplasty (-0.09 mm; a ~15% decrease). As the 2 measure- the nasal cavity in children with unilateral and bilateral cleft
ments increased with PNAM, the Friedman test performed to lip and palate and reported a wider nasal base in UCLPs who
assess the nostril height differences between cleft vs non cleft were not operated on13 compared with a normal nasal growth
sides failed to show significant differences (Table 3, Figure 3c). from a previous report from the same group.14 Similar changes
The inclination of the columella had a statistically significant were found by Ezzat et al. in their study, where stability in the
increase when the 3 times were compared, but only the T2-T3 width of the nasal base was evidenced. 15 In our data, the fact
increase was statistically significant (~18% increase after PNAM; that the width of the nose did not change after PNAM and
~82% increase after rhinocheiloplasty; Table 3, Figure 3d). lip-tape adhesion or even after rhinocheiloplasty demonstrated
A slight decrease in the median area values of the cleft that this combined approach served to stabilize this measure-
nostril after PNAM (-0.89 mm2; a ~15% decrease) was followed ment while nasal growth was occurring elsewhere.
by a major decrease after primary lip and nose surgery (median: The changes in the cleft nostril width were significant,
being higher between T2 and T3. This decrease in the mea-
surement indicated that the initially stretched cartilage had a
favorable, but nonsignificant change with the use of PNAM
that was followed by a significant reduction after rhinocheilo- The purpose of the adhesive tape was to approximate the
plasty. These findings were similar to those reported by soft tissues around the cleft. There are no references about the
Grayson et al., Maull et al., Pai et al., and Ezzat et al.5,8,15,16 The precise technique of the use of the tape regarding direction
nonsignificant decrease in nostril width measurement after and amount of force. When using the tape, the indication given
PNAM and lip-tape treatment could be an additional, positive to the parents consisted of applying pressure between the 2
change toward the improved nasal results after surgery. The segments to approximate and close the gap between them. The
difference between the cleft transversal nostril width minus the main effect of this pressure was in sagittal and transversal direc-
non-cleft one showed a reduction among the 3 timeframes of tion. In our study, however, the width of the nasal base re-
the study. This difference, however, was only significantly higher mained unchanged with the use of this approach. Although it
between T2 and T3 (Table 3). Similar effects were found by has been claimed that the use of adhesive tapes applied on the
Pai et al., in 2005, when they compared the affected side with lips could reduce the width of nasal base and help to maintain
the non-affected one and found higher transversal symmetry the plate into proper position,8,15,16 in the present study it was
after the use of PNAM.16 not the purpose of the adhesive tape to reduce this measure-
Regarding nostril height, the increase in the measure- ment or even keep the appliance in place.
ment indicated a favorable change in the cleft alar cartilage that It is well known that maxillofacial orthopedics have signifi-
was depressed at the beginning of treatment. These findings cant effects on the arch shape, especially regarding the widen-
were similar to those reported by Grayson et al., Maull et al., ing effect in anterior arch width. After its usage, the maxillary
Pai et al., and Ezzat et al.5,8,15,16 The measurements between T2 arch appears more rounded and with more room for additional
and T3 increased, although at a lesser proportion, showing that alveolar and palatal growth.17,18 Additional to these effects,
the height of the alar cartilage insertion obtained by PNAM PNAM therapy has the benefit of changing nasal cartilage form
remained stable after rhinocheiloplasty. As the cleft nostril before surgery to improve surgical results, as was shown by the
width and height PNAM results could have been affected by present study. The question regarding potential outcome dif-
the healing effect and tension in nasal tissue after rhinocheilo- ferences for intraoral characteristics between the 2 approaches
plasty, it is our recommendation that a postsurgical nasal con- (conventional vs PNAM appliances), however, remains unsolved.
former be used to keep the results obtained with PNAM, as Additional research should be undertaken to solve this issue.
was suggested by Pai et al.16 Also, our sample size limits the results to the specific popula-
The results when assessing the columella inclination indi- tion attending our clinic, and they cannot be used as a rule for
cate a significant increase from T1 to T3 in the measurement of all populations. This study demonstrated results obtained with
this angle in time. A nonsignificant improvement in the colu- the PNAM therapy, an increasingly common procedure.
mella final position before rhinocheiloplasty was observed, In summary, an improvement was found between initial
however, between T1 to T2. This indicates that PNAM ther- and final nasal form at the end of PNAM and surgery. It also
apy could play a role in the straightening of the columella, can be sustained that a percentage of the results is due to
taking the nasal tip to a more vertical position. Additional and PNAM and normal growth changes (56% improvement in
more significant surgical modifications of nasal cartilage form nostril height, 21% increase in columella length, and 18% im-
must be done, however, to totally fulfill this purpose. Addi- provement in columella deviation). The change in form of the
tional testing of the same measurement on a larger sample cleft nasal cartilage with PNAM was identified, but further ana-
would be helpful to answer this question. lysis of the available data is required to support its significance.
Similar results were found by Singh et al., who found that
the columella was placed medially after the use of PNAM, im- Conclusions
proving the projection of the nasal tip. 17 Grayson et al., re- Based on this study’s results, the following conclusions can be
ported that the use of PNAM repositions the columella, taking made:
it from an oblique position to a straighter one and oriented 1. The presurgical nasal alveolar molding technique im-
toward the midline, producing symmetry in the alar cartilage proves the alar cartilage depression, projection of the
and an optimal projection of the nasal tip.8 Ezzat et al., reported nose tip, and partially the columella deviation before
an improvement in the vertical deficiency of the nasal struc- primary lip and nose surgery in unilateral cleft lip/
ture due to tension of the columella in the affected side after palate patients in a South American population.
PNAM.15 Likewise, Pai concluded that, after this therapy, the 2. Future studies should be done next to:
angle of the columella changed, reaching values closer to the a. evaluate the effect of the nasal surgical repair of
ideal 90° and redirecting itself toward the midline.16 unilateral presurgical nasoalveolar molding vs a
When an assessment of the cleft nostril area was per- maxillofacial obturator-treated sample of unilateral
formed, a nonsignificant and gradual decrease from T1 to T3 cleft lip/palate patients; and
was found. On the other hand, the noncleft side demonstrated b. address the long-term effect of presurgical nasal
a significant increase among the endpoints of the study, being alveolar molding in nasal soft tissue esthetics
highly significant between T2 and T3 (Table 4). The same trend in unilateral cleft lip/palate patients from this
was found when an evaluation of the nostril area difference be- population.
tween cleft and noncleft sides among all endpoints was done.
Symmetric nostrils are a composite of nostril area and form. Acknowledgment
As the present study failed to identify differences between the We wish to acknowledge the Fundacion Clinica Noel and its
nostril areas, a subjective evaluation of the form of the affected Interdisciplinary CLP group, which allow us to collect all data
nasal cartilages should be done next to answer this question. used in the present research.