International Journal of Pediatric Otorhinolaryngology 101 (2017) 47e50

Contents lists available at ScienceDirect

International Journal of Pediatric Otorhinolaryngology

journal homepage: http://www.ijporlonline.com/

Treatment and post-treatment effects of functional therapy on the

sagittal pharyngeal dimensions in Class II subjects
Chiara Pavoni a, *, Elisabetta Cretella Lombardo a, Lorenzo Franchi b, c, Roberta Lione a,
Paola Cozza a, d
a
Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Italy
b
Department of Surgery and Translational Medicine, University of Florence, Florence, Italy
c
Thomas M. Graber Visiting Scholar, Department of Orthodontics and Pediatric Dentistry, School of Dentistry, The University of Michigan, Ann Arbor, MI,
USA
d
Department of Orthodontics, University Zoja e K€eshillit t€
e Mir€
e, Tirane, Albania

a r t i c l e i n f o a b s t r a c t

Article history: Objective: To evaluate the craniofacial changes induced by functional appliances with special regard to
Received 9 June 2017 the oro and nasopharyngeal sagittal airway dimensions in subjects with dentoskeletal Class II maloc-
Received in revised form clusions when compared with an untreated Class II control group immediately after therapy and at long-
22 July 2017
term observation.
Accepted 23 July 2017
Methods: A group of 40 patients (21 females and 19 males) with Class II malocclusion treated consec-
Available online 24 July 2017
utively either with a Bionator or an Activator followed by fixed appliances was compared with a matched
control group of 31 subjects (16 females and 15 males) with untreated Class II malocclusion. The treated
Keywords:
Sagittal pharyngeal dimensions
sample was evaluated at T1, start of treatment (mean age: 9.9 ± 1.4 years); T2, end of functional treat-
Functional therapy ment and prior to fixed appliances (mean age: 11.9 ± 1.3 years); and T3, long-term observation at the end
Class II malocclusion of growth (mean age: 18.2 ± 2.1 years). Statistical comparisons were performed with independent
sample t tests at T1 (baseline characteristics) and for the T1
T2, T2-T3, and T1-T3 changes.
Results: During active treatment the treated group showed a significant increment in lower airway
dimension (PNS-AD1), as well as a significant improvement in the upper airway dimension (PNS-AD2). A
significant decrease in the upper adenoid size (AD2-H) was also found. In the longterm evaluation, a
significant increase in both lower and upper airway thickness (PNS-AD1; PNS-AD2) and a significant
decrease in the upper adenoid thickness were still present in the treated group.
Conclusion: The treatment with functional appliances produced significant favorable changes during
active treatment in the oro- and nasopharyngeal sagittal airway dimensions in dentoskeletal Class II
subjects when compared with untreated controls, and these changes were stable in the long-term.
© 2017 Elsevier B.V. All rights reserved.

1. Introduction structures at varying degrees [2].

The anatomy and function of nasopharyngeal airway is directly
associated with craniofacial development [1]. Because of the close
relationship between the pharynx and the dentofacial structures a
mutual interaction is expected to occur between the pharyngeal
structures and the dentofacial pattern, and therefore validates or-
thodontic interest [2]. Several authors [3e6] have been demon-
strated that there are statistically significant relationships between
the pharyngeal structures and both dentofacial and craniofacial
* Corresponding author. Department of Clinical Sciences and Translational
Medicine, University of Rome Tor Vergata, Viale Oxford 81, 00133 Rome, Italy.
E-mail address: dott.chiarapavoni@gmail.com (C. Pavoni).
Various studies have reported that the abnormal position and
atypical growth pattern of dental and craniofacial structures can
influence pharyngeal dimensions [1]. Similarly, mouth breathing
due to adenoid hypertrophy is frequently associated with retrusion
of the mandible relative to the cranial base, increased mandibular
and palatine inclinations, vertical growth pattern, increased lower
facial height, decreased posterior facial height, and narrow palate [7].
The use of lateral cephalograms appears adequate for the
investigation of sagittal changes in the pharyngeal dimensions
[8e11]. Reproducibility of airway dimensions on lateral cephalo-
grams was found to be accurate [12].
Recently, Jena et al. showed that the anterior displacement of
the mandible by the functional appliances influences the position

http://dx.doi.org/10.1016/j.ijporl.2017.07.032
0165-5876/© 2017 Elsevier B.V. All rights reserved.
48 C. Pavoni et al. / International Journal of Pediatric Otorhinolaryngology 101 (2017) 47e50
of hyoid bone and, consequently, the position of the tongue and
thus improves the morphology of the upper airways [12].
Several studies [1,13] have been conducted to evaluate the effects
of different mandibular advancement devices on mandibular growth
and the changes occurring in pharyngeal dimensions of growing
skeletal Class II patients, but no study has evaluated the long-term
effects achieved by these functional appliances on airway dimensions.
The aim of the present study, therefore, was to evaluate the
craniofacial changes induced by functional appliances with special
regard to the oro- and naso-pharyngeal sagittal airway dimensions
in subjects with dentoskeletal Class II malocclusions when
compared with an untreated Class II control group immediately
after therapy and at a long-term observation.
2. Materials and methods
The cephalometric records of 40 patients (21 females and 19
males) with Class II division 1 malocclusion (overjet greater than
5 mm, full Class II or end-to-end molar relationships, ANB angle
greater than 4 , improvement in facial profile when the lower jaw
was postured in a forward position) treated consecutively either
with the Bionator (21 subjects) or Activator (19 subjects) were
reviewed. The subjects were collected from an orthodontic practice
(Bionator) and from the records of patients treated in the Depart-
ment of Orthodontics of the University of XXXXXXXXX (Activator).
The study project was approved by the Ethical Committee at the
University of XXXXXX, and informed consent was obtained from
the subjects' parents.
The nonextraction treatment protocols consisted either of a
Bionator constructed without coverage of the lower incisors or of an
acrylic monobloc attached to the upper arch by Adams clasps and
with capping of the upper and lower incisors. Treatment with
functional appliances finished with the achievement of Class I molar
relationship and was followed by fixed appliance therapy in the
permanent dentition. To be included in the study, the patients had to
present with lateral cephalograms available at three time periods:
T1, at the start of treatment; T2, at the end of FJO; and T3, at long-
term observation after completion of growth, including the phase
with fixed appliances. The T3 observations were collected and
analyzed regardless of the treatment outcomes in terms of correc-
tion of Class II malocclusion in the individual patients. This approach
assisted in further reducing potential selection bias of the study.
Thirty-one subjects (16 females, 15 males) with untreated Class
II division 1 malocclusion were selected from the American Asso-
ciation of Orthodontists Foundation Craniofacial Growth Legacy
Collection (http://www.aaoflegacycollection.org, BoltoneBrush
Growth Study, Michigan Growth Study, Denver Growth Study,
Oregon Growth Study, and Iowa Growth Study) to comprise the
control group.
Demographic data of the samples are reported in Table 1.
2.1. Cephalometric analysis
All lateral cephalograms of each patient were hand traced at a
single sitting. Cephalograms were traced by one investigator.
Landmark location and the accuracy of the anatomical outlines
Table 1
Demographics for the treated and control groups.
Age at T1 Age at T2
(ys) (ys)
Mean SD Mean
Treated Group (n ¼ 40, 21f 19 m) 9.9 1.3 11.9
Control Group (n ¼ 31, 16f 15 m) 10.1 1.1 12.0
were verified by a second. Any discrepancies as to landmark
placement were resolved by mutual agreement. A customized
digitization regimen (Viewbox, version 3.0, dHAL Software, Kifissia,
Greece) was created and used for the cephalometric evaluation.
Lateral cephalograms for each patient at T1, T2, and T3 were
digitized, and a custom cephalometric analysis was used. Six linear
variables were generated for each tracing. Lateral cephalograms of
treated and control groups at T1, T2, and T3 were standardized as to
magnification factor (8%).
The cephalometric measurements used were [14,15]:
1. PNS-AD1: lower airway dimension; distance between the PNS
and the nearest adenoid tissue measured through the PNS-Ba
line (AD1).
2. AD1-Ba: lower adenoid size; defined as the soft tissue thickness
at the posterior nasopharynx wall through the PNS-Ba line.
3. PNS-AD2: upper airway dimension; distance between the PNS
and the nearest adenoid tissue measured through a perpen-
dicular line to SeBa from PNS (AD2).
4. AD2-H: upper adenoid size; defined as the soft tissue thickness
at the posterior nasopharynx wall through the PNS-H line (H,
Hormion, point located at the intersection between the
perpendicular line to SeBa from PNS and the cranial base).
5. McNamara's upper pharynx dimension: the minimum distance
between the upper soft palate and the nearest point on the
posterior pharynx wall.
6. McNamara's lower pharynx dimension: the minimum distance
between the point where the posterior tongue contour crosses
the mandible and the nearest point on the posterior pharynx
wall.
3. Statistical analysis
Descriptive statistics were calculated for all the cephalometric
measurements in the two groups at T1, for the T1
T2, T2-T3, and
T1-T3 changes. All data were normally distributed (Shapiro-Wilks’
test). Between-group differences were tested with independent
sample t tests at T1 (baseline characteristics) and for the T1
T2, T2-
T3, and T1-T3 changes. Since no study in the literature investigating
the long-term effects of functional appliances on the airway di-
mensions was available, the power of the study was calculated for
an effect size of 0.8 [16] for the primary outcome variable PNS-AD2,
with an alpha level of 0.05. The power of the study was 0.909.
As for the method error, 10 subjects from the final samples (30
cephalograms) were selected at random. All films were retraced and
digitized a second time after 15 days by the same observer. The
systematic and random errors for the cephalometric variables were
analyzed with the paired t-test and Dahlberg's formula, respectively.
4. Results
No systematic error was detected for any of the variables. The
error for linear measurements ranged from 0.40 mm (McNamara's
lower pharynx dimension) to 0.68 mm (PNS-AD2).
No significant differences between the treated and the control
groups at T1 were found for any airway measurement (Table 2).
Age at T3 T1-T2 T2-T3 interval T1-T3 interval
(ys) interval (ys) (ys) (ys)
SD Mean SD Mean SD Mean SD Mean SD
1.3 18.2 2.1 2.0 0.6 6.2 2.1 8.3 2.1
1.2 17.7 1.7 1.9 0.3 5.7 1.7 7.5 1.7
 C. Pavoni et al. / International Journal of Pediatric Otorhinolaryngology 101 (2017) 47e50 49

Table 2
Descriptive statistics and statistical comparisons (independent-samples t tests) of the starting forms (cephalometric values at T1).

Variables Treated Group Control Group Diff. P value 95% CI of the difference

Mean SD Mean SD Lower Upper

PNS-AD1 21.7 5.4 23.2 5.3
1.5 0.226
4.1 1.0

AD1-Ba 23.4 5.8 21.9 5.8 1.5 0.271
1.2 4.3
PNS-AD2 16.2 4.1 17.7 4.4
1.5 0.158
3.5 0.6
AD2-H 15.5 3.6 13.7 4.2 1.8 0.056 0.0 3.6
McNamara Upper Pharinx 10.4 4.5 10.3 5.1 0.1 0.927
2.2 2.4
McNamara Lower Pharinx 11.2 3.0 10.9 3.3 0.3 0.690
1.2 1.8

SD¼ Standard Deviations; Diff. ¼ Differences; CI¼ Confidence interval.

Descriptive statistics and comparisons of the T1-T2, T2-T3, and T1-
T3 changes between treated and untreated control groups are re-
ported in Tables 3e5.
During active treatment (T1-T2; Table 3), the treated group
showed a significant increment in lower airway size (PNS-AD1), as
well as a significant improvement in the upper airway size (PNS-
AD2). A significant decrease in the upper adenoid size (AD2-H) was
also found. No statistically significant differences were observed for
any of the other analyzed variables for upper and lower sagittal
airway dimensions.
No significant differences between the treated and the control
were found for any airway measurement in the T2-T3 interval
(Table 4).
In the long-term evaluation (T1-T3; Table 5), a significant in-
crease in both lower and upper airway size (PNS-AD1; PNS-AD2)
and a significant decrease in the upper adenoid size were still
present in the treated group. No statistically significant differences
were found for any of the other analyzed variables.
5. Discussion
The present study evaluated the treatment and post-treatment
craniofacial changes produced by treatment with functional ap-
pliances of Class II malocclusions with special regard to the sagittal
oropharyngeal and nasopharyngeal airway dimensions. Although
historical control groups may be a limitation [17], historical con-
trols were used in the current study for ethical reasons, as it would
have been impossible to recruit a contemporary control group of
subjects with untreated Class II malocclusion for long-term obser-
vation. A recent investigation [18] showed that historical controls
tend to show smaller treatment effects than concurrent controls. In
other words, historical controls do not seem to amplify treatment
effects with respect to concurrent controls.
The features of the present investigation were represented by:
1. The study evaluated both active and post-treatment outcomes,
with the post-treatment observation approximately 8 years af-
ter the completion of therapy;
2. A group of 31 subjects with untreated Class II malocclusions was
used as a longitudinal control sample for both active treatment
and post-treatment periods. All subjects in both treated and
control groups were at a prepubertal or pubertal stage in skel-
etal development at initial observation and at post-pubertal
stage at the final observation.
The results of the present investigation showed significant
favorable effects of functional therapy during active treatment (T1-
T2) in the oro- and nasopharyngeal sagittal airway dimensions in
subjects with dentoskeletal Class II subjects and these favorable
changes were maintained also in the long-term observation (T2-
T3).
Few studies have analyzed the efficacy of functional appliance
treatment on pharyngeal airway dimensions in growing patients
with a Class II malocclusion and a retrognathic mandible. Ozbek

Table 3
Descriptive statistics and statistical comparisons (independent-samples t tests) of the T1-T2 changes in the Treated Group vs the Control Group.

Variables Treated Group Control Group Diff. P value 95% CI of the difference

Mean SD Mean SD Lower Upper

PNS-AD1 2.6 2.7 0.5 4.2 2.1 0.013 0.5 3.7

AD1-Ba
0.8 9.1
0.5 4.0
0.3 0.857
3.8 3.2
PNS-AD2 2.8 2.7 0.7 2.7 2.1 0.001 0.9 3.5
AD2-H
1.0 2.6 0.3 2.4
1.3 0.037
2.5
0.1
McNamara Upper Pharinx 2.4 2.9 1.7 3.1 0.7 0.323
0.7 2.2
McNamara Lower Pharinx 0.9 3.0 0.3 2.6 0.6 0.398
0.8 1.9

SD¼ Standard Deviations; Diff. ¼ Differences; 25/75 ¼ 25th/75th percentile; CI¼ Confidence interval.

Table 4
Descriptive statistics and statistical comparisons (independent-samples t tests) of the T2-T3 changes in the Treated Group vs the Control Group.

Variables Treated Group Control Group Diff. P value 95% CI of the difference

Mean SD Mean SD Lower Upper

PNS-AD1 2.5 4.1 1.1 2.9 1.4 0.115
0.3 3.1

AD1-Ba
1.0 4.5
0.2 3.1
0.8 0.391
2.7 1.1
PNS-AD2 3.3 3.9 3.2 2.7 0.1 0.904
1.5 1.7
AD2-H
2.5 4.0
1.9 3.1
0.6 0.452
2.4 1.1
McNamara Upper Pharinx 3.2 3.6 2.7 2.9 0.5 0.552
1.1 2.0
McNamara Lower Pharinx 0.9 3.6 0.3 2.2 0.6 0.470
0.9 2.0

SD¼ Standard Deviations; Diff. ¼ Differences; CI¼ Confidence interval.

50 C. Pavoni et al. / International Journal of Pediatric Otorhinolaryngology 101 (2017) 47e50

Table 5
Descriptive statistics and statistical comparisons (independent-samples t tests) of the T1-T3 changes in the Treated Group vs the Control Group.

Variables Treated Group Control Group Diff. P value 95% CI of the difference

Mean SD Mean SD Lower Upper

PNS-AD1 5.1 3.7 1.5 3.7 3.6 0.000 1.9 5.4

AD1-Ba
1.8 7.6
0.7 4.1
1.1 0.469
4.1 1.9
PNS-AD2 6.1 3.7 3.9 3.1 2.2 0.007 0.6 3.9
AD2-H
3.5 4.1
1.6 3.2
1.9 0.033
3.7
0.2
McNamara Upper Pharinx 5.6 4.0 4.4 3.5 1.2 0.193
0.6 3.0
McNamara Lower Pharinx 1.8 4.0 0.7 2.7 1.1 0.195
0.6 2.8

SD ¼ Standard Deviations; Diff. ¼ Differences; 25/75 ¼ 25th/75th percentile; CI¼ Confidence interval.

et al. [19] compared pharyngeal airway dimensions in 26 Class II
children treated with the Harvold-type activator to 15 controls.
They found that the pharyngeal airway dimensions significantly
increased by functional orthopedic treatment. In agreement with
Ozbek et al. [19], we observed that the upper and lower airway
dimension showed a significant increase (PNS-AD1, þ2.1 mm; PNS-
AD2, þ2.1 mm) and we also found a reduction of upper adenoid size
(AD2-H,
1.3 mm). In a work published in 2011, Restrepo et al. [20]
confirmed that when the measurements before and after treatment
were compared, a statistically significant increase in the airway
dimension was found at the space where the adenoid tissue was
located.
In the appraisal of the lack of significant treatment-induced
airway modifications, the physiological changes in the lymphoid
tissue on the posterior pharyngeal wall should also be considered.
Handelman and Osborne [21] reported that during the pre-school
years, the adenoid area increases more than the bony nasopha-
ryngeal area, resulting in a restriction of airway space. Linder-
Aronson and Leighton [22] analyzed the development of the pos-
terior nasopharyngeal wall between 3 and 16 years and found that
the size of the soft tissue was greater at 5 years; thereafter, a
decrease occurred from 6 to 10 years. In agreement with this
physiological growth pattern of the oronasal lymphoid tissue. The
results of the present study revealed a decrease of the lymphoid
tissue on the posterior pharyngeal wall (AD2-H) in the treated
group during the overall observation period. When considering this
decrease of pharyngeal lymphoid tissue between 9 and 10 years (an
interval in age similar to the one in the present study), therapeutic
intervention with mandibular advancement was able to produce a
significant increase in the airway dimensions.
The increase in the dimensions of the oropharynx found in this
investigation agrees with other studies, which found that treat-
ment with functional appliances leads to significant increase in the
extent of the oropharyngeal space [20,23].
In literature exists a lack of long-term observations of the airway
dimensions after finishing the treatment with functional appli-
ances. This kind of follow-up is necessary to determine the stability
of this type of treatments before, during, and after the growth peak
[20].
In the present study, we evaluated the stability of our results in
the post treatment observation and we observed that the favorable
changes obtained on the oro- and nasopharyngeal sagittal airway
dimensions were maintained in the long-term.
6. Conclusions
The findings of the present study demonstrated the followings:
1. The treatment with functional appliances produced significant
favorable changes during active treatment (T1-T2) in the oro-
and nasopharyngeal sagittal airway dimensions in subjects with
dentoskeletal Class II subjects when compared with untreated
controls.
2. The favorable changes obtained during T1-T2 interval were
maintained in the long-term observation after puberty (T1-T3
interval).
References
[1] B. Ali, A. Shaikh, M. Fida, Effect of Clark's twin-block appliance (CTB) and non-
extraction fixed mechano-therapy on the pharyngeal dimensions of growing
children, Dent. Press J. Orthod. 20 (2015) 82e88.
[2] I. Ceylan, H. Oktay, A study on the pharyngeal size in different skeletal pat-
terns, Am. J. Orthod. Dentofac. Orthop. 108 (1995) 69e75.
[3] G.F. Dunn, L.J. Green, J.J. Cunat, Relationships between variation of mandibular
morphology and variation of nasopharyngeal airway size in monozygotic
twins, Angle Orthod. 43 (1973) 129e135.
[4] J.A. McNamara, Influence of respiratory pattern on craniofacial growth, Angle
Orthod. 51 (1981) 269e300.
[5] B. Solow, S. Siersbzek-Nielsen, E. Greve, Airway adequacy, head posture, and
craniofacial morphology, Am. J. Orthod. 86 (1984) 214e223.
[6] W.J.S. Kerr, The nasopharynx, face height, and overbite, Angle Orthod. 55
(1985) 31e36.
[7] M. Baroni, F. Ballanti, L. Franchi, P. Cozza, Craniofacial features of subjects with
adenoid, tonsillar, or adenotonsillar hypertrophy, Prog. Orthod. 12 (2011)
38e44.
[8] S. Hiyama, N. Suda, M. Ishii-Suzuki, S. Tsuiki, M. Ogawa, S. Suzuki, T. Kuroda,
Effects of maxillary protraction on craniofacial structures and upper airway
dimension, Angle Orthod. 72 (2002) 43e47.
[9] K. Sayinsu, F. Isik, T. Arun, Sagittal airway dimension following maxillary
protraction: a pilot study, Eur. J. Orthod. 28 (2006) 184e189.
[10] S. Kilinç, S.G. Arslan, J.D. Kama, T. Ozer, € O. Dari, Effects on the sagittal
pharyngeal dimensions of protraction and rapid palatal expansion in Class III
malocclusion subjects, Eur. J. Orthod. 30 (2008) 61e66.
[11] H. Oktay, E. Ulukaya, Maxillary protraction appliance effect on the size of the
upper airway passage, Angle Orthod. 78 (2008) 209e214.
[12] A.K. Jena, S.P. Singh, A.K. Utreja, Effectiveness of twin-block and Mandibular
Protraction Appliance-IV in the improvement of pharyngeal airway passage
dimensions in Class II malocclusion subjects with a retrognathic mandible,
Angle Orthod. 83 (2013) 728e734.
[13] P. Cozza, A. Polimeni, F. Ballanti, A modified monobloc for the treatment of
obstructive sleep apnoea in paediatric patients, Eur. J. Orthod. 26 (2004)
523e530.
[14] J.A.J.R. McNamara, A method of cephalometric evaluation, Am. J. Orthod. 86
(1984) 449e469.
[15] O. Martin, L. Muelas, M.J. Vinas, Nasopharyngeal cephalometric study of ideal
occlusion, Am. J. Orthod. Dentofac. Orthop. 130 (2006) 436 e1ee9.
[16] J. Cohen, A power primer, Psychol. Bull. 112 (1992) 155e159.
[17] N. Pandis, Use of controls in clinical trials, Am. J. Orthod. Dentofac. Orthop. 141
(2012) 250e251.
[18] S.N. Papageorgiou, V. Koretsi, A. J€ ager, Bias from historical control groups used
in orthodontic research: a meta-epidemiological study, Eur. J. Orthod. 39
(2017) 98e105.
€ gen, A.A. Lowe, E. Baspinar, Oropharyngeal
[19] M.M. Ozbek, T.U. Memikoglu, H. Go
airway dimensions and functional-orthopedic treatment in skeletal Class II
cases, Angle Orthod. 68 (1998) 327e336.
[20] C. Restrepo, A. Santamaría, S. Pela ez, A. Tapias, Oropharyngeal airway di-
mensions after treatment with functional appliances in class II retrognathic
children, J. Oral Rehabil. 38 (2011) 588e594.
[21] C.S. Handelman, G. Osborne, Growth of the nasopharynx and adenoid
development from one to eighteen years, Angle Orthod. 46 (1976) 243e259.
[22] S. Linder-Aronson, B.C. Leighton, A longitudinal study of the development of
the posterior nasopharyngeal wall between 3 and 16 years of age, Eur. J.
Orthod. 5 (1983) 47e58.
[23] S. Yassaei, Z. Bahrololoomi, M. Sorush, Changes of tongue position and
oropharynx following treatment with functional appliance, J. Clin. Pediatr.
Dent. 31 (2007) 287e290.