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Comparacion Clinica Pre-Cirugia
Comparacion Clinica Pre-Cirugia
Comparacion Clinica Pre-Cirugia
Original Article
Comparative clinical evaluation of modified and conventional
Grayson’s presurgical nasoalveolar molding technique in infants with
complete unilateral cleft lip and palate
Seema Thakur1, C. Jishad1, Parul Singhal1, Deepak Chauhan1
1
Department of Pediatric and Preventive Dentistry, HP Government Dental College and Hospital, Shimla, Himachal Pradesh, India
ABSTRACT
Background: Presurgical nasoalveolar molding (PNAM) was introduced by Grayson et al., in
1993 to presurgically mold the alveolus, lip, and nose in infants with cleft lip and palate (CLP). The
aim of this comparative clinical trial was to evaluate the efficacy and efficiency of Modified and
Conventional Grayson’s PNAM in patients concerning morphological and anatomical changes in
maxillary alveolus, nasal symmetry, number of visits, and duration of treatment.
Materials and Methods: In this comparative clinical trial study, 16 infants with unilateral complete
CLP were equally divided into two groups: Group I (modified PNAM technique using titanium
molybdenum alloy [TMA] wire nasal stent) and Group II (conventional PNAM technique using
stainless steel wire nasal stent). Patient photographic evaluation of nasal symmetry and maxillary
study model CAD‑CAM analysis, pre‑ and post‑operatively in both groups, were compared using a
Received: 27-Dec-2019 paired t‑test between the groups using the Chi‑square test with P < 0.05 as statistically significant.
Revised: 14-May-2020
Accepted: 20-Sep-2020 Results: In both groups, on evaluating nasal measurements, statistically significant (P < 0.05) decrease
Published: 18-Aug-2021 in nasal width and increase in columella deviation angle, a decrease of nostril length, and an increase
of columella length in Group I were observed. On maxillary study model evaluation, a statistically
Address for correspondence:
Dr. Seema Thakur,
significant (P < 0.05) decrease in width of the alveolar cleft was noticed in both groups and lateral
Room No. 302, Department deviation of the incisal point in Group I and width of the palatal cleft in Group II was noticed.
of Pediatric and Preventive Conclusion: This study showed a morphological improvement in nasal symmetry and maxillary
Dentistry, HP Government alveolar morphology in complete unilateral CLP patients, treated with both Modified and
Dental College and Hospital,
Shimla, Himachal Pradesh,
Conventional PNAM techniques, with the Modified PNAM technique being more efficient for
India. treatment duration and the number of adjustments as there are less number of visits.
E‑mail: cima2009@hotmail.
com Key Words: Cleft lip, cleft palate, nasal, titanium molybdenum alloy, unilateral
Exclusion criteria
1. All the clefts of lip, alveolus, and palate excluding
complete UCLP
2. Clefts associated with other craniofacial anomalies
or syndromes
3. Patients with respiratory difficulty and upper
respiratory tract infection
4. Patients who suffered from any life‑threatening
a
disorder.
b
Methodology
After making an intraoral maxillary impression
with heavy‑bodied silicon impression
material (Affinis, Coltene, Altstatten, Switzerland),
a maxillary intraoral plate was made of self‑cure
acrylic resin (DPI‑RR, Mumbai, Maharashtra,
India). A retentive button was fabricated and
positioned at an angle of 40°–45° down from the
c d horizontal to achieve proper activation and to
Figure 1: Photographs of a patient treated in Group I: (a) prevent unseating of the appliance from the palate.
Preoperative standard basilar view photograph, (b) postoperative The labial flange of the intraoral plate holds a
standard basilar view photograph, (c) preoperative maxillary wire with a loop for adjustments and at its end,
study model photograph, (d) postoperative maxillary study a nasal stent was wrapped with self‑cure acrylic.
model photograph. In the Modified Grayson’s PNAM technique,
the nasal stent was made of 0.032” TMA wire,
whereas in the Conventional Grayson’s technique,
the PNAM appliance holds a nasal stent made of
0.036” stainless steel wire. After the initial lip
taping for the approximation of the lip segments,
the appliance was then secured extraorally to
the cheeks and bilaterally by surgical tapes that
had elastic bands at one end. Modifications of
the appliance were done until the pressure of the
a b nasal extension made the cleft nasal cartilage
appear rounded and symmetrical as the noncleft
side. In the Modified Grayson’s PNAM technique,
the patient was recalled every 15–20 days, in
comparison to 7–10 days in the Conventional
Grayson’s PNAM technique.
Assessment of the study models and facial
photographs
c d
Photographic analysis
At resting posture, the infant’s head was tilted
Figure 2: Photographs of a patient treated in Group II: (a)
Preoperative standard basilar view photograph, (b) postoperative back to bring the alar domes to a level below the
standard basilar view photograph, (c) preoperative maxillary eyebrows but above the canthi for taking a series of
study model photograph, (d) postoperative maxillary study standard basilar view photographs in 1:1 ratio using
model photograph. a digital camera (Lumix DMC‑FS4, Panasonic,
Kadoma, Japan). Indirect anthropometric unilateral
3. Infants who have not undergone any surgery in the measurements (nostril width, columella deviation)
cleft region and bilateral measurements (columella length,
4. Infants without any presurgical intervention. nostril length, and nostril axis inclination) were
Table 2: Maxillary study model landmarks and measurements (adapted from Isogawa et al.)
Serial number Abbreviation Definition
Landmarks
1 I The crossing point of alveolar ridge and the line from incisive papilla to frenulum
2 T (r) The maxillary tuberosity on the right side
3 T (l) The maxillary tuberosity on the left side
Measurements
1 WA Width of the alveolar cleft
2 WP Width of the palatal cleft
3 RD The length between I and T (r)
4 LD The length between I and T (l)
5 ID The length between T (r) and T (l)
6 LDI Lateral deviation of the incisal point
The lateral deviation of the incisal point (LDI) = | RD2−LD2 |/2 ID. LDI: Lateral deviation of the incisal point
Table 3: Nasal measurements (unilateral) and quantity of asymmetry (linear difference of each bilateral
measurement between cleft and noncleft sides) pre‑ and post‑operatively using the Modified and Conventional
Grayson’s presurgical nasoalveolar molding techniques using paired t‑test
Variables Group I (Modified Grayson’s PNAM) (n=8) Group II (Conventional Grayson’s PNAM) (n=8)
Preoperatively Postoperatively P Outcomes Percentage Preoperatively Postoperatively P Outcomes Percentage
increase/ increase/
decrease decrease
Nasal
measurements
(unilateral)
Nasal width 225.956±35.66 170.827±23.50 0.001* Decreased −24.3 172.955±38.55 142.549±43.71 0.014* Decreased −17.5
(pixels)
CD angle (°) 55.780±5.94 64.853±7.35 0.014* Increased 16.2 47.462±11.11 60.919±5.06 0.019* Increased 28.3
Nasal
asymmetry
(Bilateral)
CL (pixels) −27.808±9.73 −18.411±5.11 0.034* Increased 33.7 −18.097±4.66 −16.201±4.97 0.476 Increased 10.4
NL (pixels) 62.516±20.15 33.084±9.34 0.003* Decreased −47.0 44.530±18.73 24.713±9.30 0.034* Decreased −44.5
NAI (°) −36.883±6.82 −35.047±9.70 0.668 Increased 4.9 −29.202±12.65 −28.282±15.46 0.905 Increased 3.1
Values are expressed as mean±SD, where SD: standard deviation. A decrease in percentage was indicated by a negative sign. *P<0.05 significant using paired
t‑test. PNAM: Presurgical nasoalveolar molding; SD: Standard deviation; CD: Columella deviation; NAI: Nostril axis inclination; NL: Nostril length; CL: Columella
length
PNAM therapy in both groups will be described. The differences pre‑ and post‑operatively in each group as
methodology involved was fruitful in determining the well as between the groups as follows.
Dental Research Journal / 2021 5
Thakur, et al.: Molding smiles into perfection
Table 4: Maxillary study model measurements pre‑ and post‑operatively using the Modified and Conventional
Grayson’s presurgical nasoalveolar molding techniques using paired t‑test
Variables Group I (Modified Grayson’s PNAM) (n=8) Group II (Conventional Grayson’s PNAM) (n=8)
Preoperatively Postoperatively P Outcomes Percentage Preoperatively Postoperatively P Outcomes Percentage
increase/ increase/
decrease decrease
WA (mm) 12.357±2.35 4.193±1.67 0.000* Decreased −66.0 11.226±3.82 4.636±3.65 0.003* Decreased −58.7
WP (mm) 14.600±2.16 13.563±2.22 0.246 Decreased −7.1 13.755±1.94 11.255±2.22 0.031* Decreased −18.1
Lateral 6.352±3.18 2.989±2.07 0.018* Decreased −52.9 4.844±2.53 3.375±1.80 0.205 Decreased −30.3
deviation of
the incisal
point (mm)
Values are expressed as mean±SD. A decrease in percentage was indicated by a negative sign. *P<0.05 significant using paired t‑test. WA: Width of the alveolar
cleft; WP: Width of the palatal cleft; SD: Standard deviation; PNAM: Presurgical nasoalveolar molding
Table 6: The percentage increase/decrease of the maxillary study model measurements in Group I and Group II
Variables Group I (n=8) Group II (n=8) P
WA (%) −66.00 −58.70 0.77
WP (%) −7.10 −18.10 0.52
Lateral deviation of the incisal point (%) −52.90 −30.30 0.374
Values are expressed as percentages. A decrease in percentage is indicated by a negative sign. *P<0.05 significant using Chi‑square test. WA: Width of the
alveolar cleft; WP: Width of the palatal cleft
Table 7: Comparison of efficiency between Group I technique as compared to the Conventional PNAM
and Group II technique, making it a more user‑friendly technique.
Variable Group I Group II P
Kecik and Enacar[17] conducted a similar study
Duration of treatment (days) 134±22.1 136±33.8 0.116
assessing the effects of PNAM in 22 unilateral
Number of adjustments 6.50±1.3 14.91±2.3 0.000*
complete CLP patients using scanned facial casts.
*P<0.05 significant using Chi‑square test. Values are expressed as mean±SD.
SD: Standard deviation They concluded a statistically significant decrease of
the cleft width (P < 0.001), increase in the columella
DISCUSSION deviation angle (P < 0.001), and a decrease in the
total alar base width (P < 0.001) on the cleft side.
The objective of the present study was to evaluate the Our results with both the Modified and Conventional
anatomic changes occurring in the unilateral cleft lip PNAM techniques also corroborate these findings.
nose and the maxillary alveolus after the Modified In the present study, similar measurement for
and Conventional Grayson’s PNAM techniques in cleft width was width of the alveolar cleft,
a group of patients with complete UCLP. Digital which decreased statistically significantly in both
analysis of standardized photographs and 3D scanned groups (P = 0.000 in the Modified PNAM and
maxillary study models were undertaken to assess P = 0.003 in the Conventional PNAM), columella
the nasal as well as maxillary alveolar changes, to deviation angle increased statistically significantly in
assess the results attained after the use of two PNAM both groups (P = 0.014 in the Modified PNAM and
techniques, and to curtail the UCLP deformity. P = 0.019 in the Conventional PNAM), and similar
In this study, both the Modified and Conventional measurement for total alar base in the present study
Grayson’s PNAM techniques showed improvement was nasal width, which also decreased statistically
in the nasal symmetry and maxillary alveolar significantly in both groups (P = 0.001 in the Modified
morphology. There was a significant reduction of nasal PNAM and P = 0.014 in the Conventional PNAM).
width and columella deviation angle postoperatively Gomez et al.[15] conducted a study on thirty UCLP
using both the techniques when unilateral nasal patients (19 males and 11 females) who received
measurements were considered. When considering PNAM before lip repair. The nasal asymmetry (linear
nasal asymmetry of bilateral measurements, there difference of each bilateral measurement between
was a significant increase of columella length and cleft and noncleft sides) of bilateral measurement
decrease in nostril length postoperatively using the shows an improvement of columella length by
Modified PNAM technique, whereas there was a 45.02%, nostril axis inclination by 27.69%, and a
significant decrease in nostril length postoperatively nonsignificant increase of nostril length. In the present
using the Conventional PNAM technique. There study, columella length improved significantly in the
was no significant difference between Group I and Modified PNAM group (33.7%) and nonsignificantly
Group II when the percentage increase/decrease in in the Conventional PNAM group (10.4%). Nostril
nasal measurements and symmetry were considered. axis inclination improved nonsignificantly in both
There was a significant reduction in the width of groups (4.9% in the Modified PNAM and 3.1% in
the alveolar cleft in both groups and a significant the Conventional PNAM) and nostril length also
decrease in the lateral deviation of the incisal point improved significantly in both groups (47% in the
in Group I postoperatively when digital maxillary cast Modified PNAM and 44.5% in the Conventional
measurements were considered. However, the number PNAM). While considering the unilateral
of adjustments of the appliance and thereby the measurements, columella deviation improved by
number of visits were lesser in the Modified PNAM 10.43% and nasal width increased by 9.07%. In the
present study, columella deviation also improved acrylic, and prevention of tongue insertion into the
significantly in both groups (16.2% in the Modified cleft, leading to a separation of the cleft margins
PNAM and 28.3% in the Conventional PNAM). All and using adhesive tape traction applied across the
the measurements in our present study show similar cleft lip as proposed by Grayson et al.[10] Isogawa
results with those of Gomez et al. except increasing et al.[16] assessed the effect of the palatal molding plate
nasal width, which is in contradiction to our study, appliance (modified Hotz’s plate and modified PNAM
where the nasal width decreased significantly in both appliance) on the alveolar and palatal forms through
groups (24.3% in the Modified PNAM and 17.5% in a quantitative and 3D evaluation. They reported a
the Conventional PNAM). significant reduction in the width of the alveolar
cleft and lateral deviation of the incisal point using a
Singh et al.[18] compared the efficacy and efficiency
modified PNAM appliance, which was similar to our
of Grayson’s technique with Figueroa’s modified
study, where the reduction in the width of alveolar
presurgical nasoalveolar technique in 22 infants
cleft was 66% in the Modified PNAM technique
with complete UCLP. When they compared nasal
and 58.7% in the Conventional PNAM technique. In
asymmetry, it was found that the nostril height increased
addition, a reduction in the lateral deviation of the
statistically significantly (P < 0.001) and nostril width
incisal point was 52.9% using the Modified PNAM
decreased statistically significantly (P < 0.001) on the
technique and 30.3% in the Conventional PNAM
cleft side postoperatively. The similar measurement
technique.
for nostril height in our study, i.e., the columella
length, also increased statistically significantly in the The results of this study should be viewed in light of
Modified PNAM group (P = 0.034) and increased its limitations. This study was a preliminary study to
nonsignificantly in the Conventional PNAM evaluate the clinical effectiveness and efficiency of
group (P = 0.476). The similar measurement for PNAM therapy using the Modified and Conventional
nostril width in our study, i.e., the nostril length, also PNAM techniques with the need for a larger sample,
decreased statistically significantly (P = 0.003 in the randomized controlled trial for confirming the
Modified PNAM and P = 0.034 in the Conventional current findings. This study is also limited by the
PNAM) in both groups. photographic analysis of nasal symmetry, which
was a two‑dimensional depiction of a 3D structure.
In our study, patients treated with the Modified Although techniques for 3D direct facial images such
Grayson’s PNAM technique exhibited a as 3D stereophotogrammetry have been proposed
significant improvement in the nasal symmetry to overcome this constraint, their higher cost limits
vertically (columellar length; P < 0.05), routine availability.[20‑23] Finally, though the results of
horizontally (nasal width, nostril length; P < 0.05), the study demonstrate the effectiveness and efficiency
and in angular measurements (nostril axis inclination, of the technique, long‑term follow‑up studies are
columella deviation; P < 0.05). Very few case required to evaluate the prolonged benefits of this
reports have been done in comparing the pre‑ and approach.
posttreatment outcomes on the Modified Grayson’s
PNAM technique using TMA wire as a nasal stent. CONCLUSION
Subramanian et al.[19] reported a case of unilateral
complete CLP treated using Grayson’s PNAM Within the limitations of this study, both the
technique with TMA wire as a nasal stent. They Modified and Conventional PNAM techniques show
concluded that lesser chairside time, easy adjustments, morphological improvement in nasal symmetry and
and a lesser number of recall visits were needed in the maxillary alveolar morphology in the presurgical
Modified PNAM treatment. They also stated that this management of unilateral complete CLP patients.
technique is an effective alternative to a conventional However, the lesser number of adjustments of the
appliance, and it simplifies the appliance modification appliance and thereby the reduced number of visits
process during follow‑up visits. in the Modified PNAM technique, make it a more
The effects on the alveolar cleft were accomplished user‑friendly technique and ultimately reducing the
by the combined effect of redirection of growth of burden of care in UCLP patients.
the alveolar segments through the molding plate, Declaration of patient consent
active molding by selective addition and removal of The authors certify that they have obtained all
appropriate patient consent forms. In the form the 11. Dec W, Shetye PR, Davidson EH, Grayson BH, Brecht LE,
patient(s) has/have given his/her/their consent for his/ Cutting CB, et al. Presurgical nasoalveolar molding and primary
her/their images and other clinical information to be gingivoperiosteoplasty reduce the need for bone grafting in
patients with bilateral clefts. J Craniofac Surg 2013;24:186‑90.
reported in the journal. The patients understand that
12. Murthy PS, Deshmukh S, Bhagyalakshmi A, Srilatha K. Pre
their names and initials will not be published and surgical nasoalveolar molding: Changing paradigms in early cleft
due efforts will be made to conceal their identity, but lip and palate rehabilitation. J Int Oral Health 2013;5:70‑80.
anonymity cannot be guaranteed. 13. Uzel A, Alparslan ZN. Long‑term effects of presurgical infant
Financial support and sponsorship orthopedics in patients with cleft lip and palate: A systematic
review. Cleft Palate Craniofac J 2011;48:587‑95.
Nil.
14. Fuchigami T, Kimura N, Kibe T, Tezuka M, Amir MS, Suga H,
Conflicts of interest et al. Effects of pre‑surgical nasoalveolar moulding on maxillary
The authors of this manuscript declare that they have arch and nasal form in unilateral cleft lip and palate before lip
no conflicts of interest, real or perceived, financial or surgery. Orthod Craniofac Res 2017;20:209‑15.
non-financial, in this article. 15. Gomez DF, Donohue ST, Figueroa AA, Polley JW. Nasal changes
after presurgical nasoalveolar molding (PNAM) in the unilateral
cleft lip nose. Cleft Palate Craniofac J 2012;49:689‑700.
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