The Cleft Palate–Craniofacial Journal 00(00) pp.

000–000 Month 2015

Ó Copyright 2015 American Cleft Palate–Craniofacial Association

ORIGINAL ARTICLE

Oral Health–Related Quality of Life in Children in Chile Treated for Cleft Lip
and Palate: A Case-Control Approach
Pedro C. Aravena, D.D.S., Ph.D., Tania Gonzalez, D.D.S, Tamara Oyarzún, D.D.S, César Coronado, D.D.S, M.Sc.

?1 Objective: To compare the oral health–related quality of life of patients treated for cleft lip
and/or cleft palate (CL/P) versus unaffected children between 8 and 15 years of age using a
Spanish-language version of the Child Oral Health Impact Profile (COHIP-Sp) administered to a
?2 Chilean population.
Design: A cross-sectional study with a matched case-control design was used.
Methods: Participants were 48 children (mean age 11.3 years) with a history of CL/P from
three cities in Chile and one group of 96 children (mean age 11.2 years) unaffected by CL/P. The
COHIP-Sp was applied to both groups. Quality of life was compared according to the overall
score and the average score of items and domains on the COHIP-Sp scale between the two
groups (Mann-Whitney U test; P , .05).
Results: The COHIP-Sp score was 94.1 6 19.3 in children with CL/P and 97.1 6 15.6 for the
control group (P ¼ .31). A significantly lower score was observed in the group with CL/P in the
domains ‘‘functional well-being’’ (P ¼ .001) and ‘‘school environment’’ (P ¼ .001); the only average
in favor of the quality of life in children with CL/P was in ‘‘self-image’’ (P ¼ .0002).
Conclusion: The oral health–related quality of life of children with a history of CL/P was
similar to that of the control group. Nevertheless, a lower quality of life was observed concerning
items associated with speech and being understood by other people. Further study into the risk
factors associated with surgery and rehabilitative treatment is recommended.

KEY WORDS: child; Chile; cleft lip; cleft palate; oral health; quality of life

Cleft lip and/or cleft palate (CL/P) is one of the most
frequent congenital malformations, with a worldwide
prevalence estimated at 0.8/1000 live births (World Health
Organization, Human Genetics Programme, 2002), and
there is a significant variation in global incidence,
depending on geography, gender, race, and ethnic group,
among others (Rozendaal et al., 2012). South America has
one of the highest frequencies in the world: in Bolivia, it is
2.5 per 1000 live births and in Argentina, 1.5 per 1000 live
births (Nazer et al., 2010). Colombia and Brazil have
reported a prevalence of 1 per 1000 live births (Hurtado et
al., 2008; Raposo-do-Amaral et al., 2011). In Chile, the
reported frequency is 1.8 per 1000 live births, with 452 new
cases reported annually (Chilean Ministry of Health
[MINSAL], 2009); however, local reports in the Los Rı́os
Dr. Aravena is Professor, Institute of Anatomy, Histology and
Pathology, Faculty of Medicine, Universidad Austral de Chile,
Valdivia, Chile. Ms. González and Ms. Oyarzún are Dentists, location.
Mr. Coronado is Professor, Department of Morphofunction, Faculty
of Medicine, Universidad Diego Portales, Santiago, Chile.
Financial support: This study had private financial support from the
researchers and the School of Dentistry, Universidad Austral de Chile.
Submitted March 2015; Revised May 2015; Accepted May 2015.
Address correspondence to: Dr. Pedro C. Aravena, School of
Dentistry, Universidad Austral de Chile, 1640 Rudloff Street,
Valdivia, Chile. E-mail paravena@uach.cl.
DOI: 10.1597/15-095
Region in the south of Chile show this prevalence increasing
to 2.03 per 1000 live births (Rosa, 2010).
The treatment of patients with CL/P seeks to achieve
normal growth and development of the face, complete
closure of the cleft, comprehensible speech, normal hearing,
a good esthetic result, and consequently correct socializa-
tion (Eberlinc and Koželj, 2012). There are, however,
certain sequelae that will influence quality of life, such as
difficulties in eating, speaking, oral hygiene, esthetics,
growth, and other physical problems such as ear infections,
alterations in hearing, and a psychosocial burden (Ward et
al., 2013). Oral health complications are numerous,
including dental agenesis and supernumerary and poorly
positioned teeth (Chapados, 2000), and cause speech
disorders such as hypernasality and facial alterations such
as nose and mouth asymmetry, which also affect the
individual’s self-image, social affiliation, and adaptation
(Broder et al., 1994; Berk et al., 2001). In response to this
situation, the measurement of oral health–related quality of
life has become an important health indicator and reveals
the functional and psychosocial results of oral diseases and
conditions (Cohen, 1997, quoted by Do and Spencer, 2008).
Broder and Wilson-Genderson (2007) adapted and
validated the Child Oral Health Impact Profile (COHIP)
in English to measure quality of life in terms of oral health,
functional well-being, social-emotional well-being, school

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 0 Cleft Palate–Craniofacial Journal, March 2016, Vol. 53 No. 2
environment, and self-image in children 8 to 15 years old,
recruiting participants with various oral health conditions
such as craniofacial, orthodontic, and general pediatric
dental anomalies. This scale presented a high internal
consistency and an excellent test-retest reliability, contrib-
uting a valuable instrument for the assessment of the oral
health–related quality of life in children with CL/P (Broder
et al., 2014).
The use of the COHIP in children with CL/P could show
the impact of this condition and sequelae after treatment
such as esthetic and speech problems, nervousness when
speaking in public or at school (Chetpakdeechit et al., 2009)
or obvious self-image problems (Berk et al., 2001);
therefore, the use of the COHIP at the local level could
reveal similar and relevant issues to ascertain the oral health
of this population.
In light of the bibliographic references presented, we
propose the following hypothesis: children between 8 and
15 with a history of surgically treated CL/P exhibit an oral
health–related quality of life similar to children unaffected
by this condition in a Chilean population.
The aim of this study was to determine oral health–
related quality of life by means of an adapted Spanish-
language version of the COHIP in children and adolescents
between 8 and 15 years old treated surgically for non-
syndromic CL/P and to compare it with children and
adolescents unaffected by CL/P in a Chilean population.
METHODS
Design and Patients
A cross-sectional study with a matched case-control
design was conducted and approved for the Ethical and
Research Committee of the Regional of Health Depart-
ment of Chile (Register No. 152/2014). Forty-eight
children and adolescents with a history of CL/P
participated (average age 11.3 6 2.3 years; 62.5% male)
and were treated surgically in primary care hospitals in
Chile: Hospital Base in Valdivia, San Borja Arriarán
Hospital in Santiago, and the Assistance Network for
Children With Cleft Lip/Palate in Puerto Montt City. In
addition, there was a control group of 96 children and
adolescents unaffected by CL/P (average age 11.2 6 2.3
years; 46.8% male) from public schools in Valdivia,
Chile. For matching the two study groups, a number of
children were selected at a 2:1 ratio between unaffected
children and those with a history of CL/P and of similar
?3 age, gender, and the same DMFT index (Lucas et al.,
2000), as this index was statistically similar between the
two groups (CL/P group DMFT index ¼ 2.2 6 2.8;
control group DMFT index ¼ 2.7 6 2.6; P . .05).
The group of children with a history of CL/P was
selected by convenience sampling. Those children
between 8 and 15 years of age were included who could
read and write in Spanish, who agreed voluntarily to
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participate through a written informed consent, and
whose parents signed an informed consent. Children or
adolescents who presented a disabling medical condi-
tion, syndromic CL/P, or mental disorders were
excluded. The children in the control group were
selected by means of simple random sampling from five
public schools in Valdivia.
Regarding the external validity of our results, the
sample size was based on the incidence rate of children
with CL/P in Chile calculated on the basis of a power of
80%, 95% confidence level according to the overall
population of Valdivia consistent with its overall birth
rate and rate of live births with CL/P in Chile ¼ 1.8/1000
(MINSAL, 2009). This calculation detected a difference
of 13.3 points on the overall COHIP score between
children with CL/P and the control group (Broder and
Wilson-Genderson, 2007; Ward et al., 2013) and
matching with double the number of subjects in the
control group (Argimon and Jiménez, 2004). This
calculation provided a minimum number of 31 subjects
between 8 and 15 years (EPIDAT 3.0, Statistical
Analysis Software)
Adaptation and Validity of the COHIP to Spanish
The first stage was to adapt the COHIP to Spanish.
This instrument is composed of five domains (well-being
in oral health, functional well-being, social-emotional
well-being, school environment, and self-image), with a
total of 34 items. Each item is valued on a 5-item Likert-
type scale ranging from 0 to 4 (4 ¼ never, 3 ¼ almost
never, 2 ¼ sometimes, 1 ¼ fairly often, and 0 ¼ always),
with the exception of the domain ‘‘self-image,’’ which
presents a score assigned with an ordinal and increasing
number (Broder, 2007). The questions with no response
are scored as zero. The total score of the scale varies
between 0 and 136, where a higher score corresponds to
a better oral health–related quality of life (Broder and
Wilson-Genderson, 2007).
In its adaptation, the COHIP was translated from
English to Spanish simultaneously by two investigators
(T.G. and T.O.), who then agreed with a third English-
speaking investigator on a definitive version called
COHIP-Sp. This was taken to a qualitative review
process in terms of face and construct validity by five
experts in the treatment of children with CL/P and a
focus group with 15 children from 8 to 15 years old from
a public school in Valdivia. In this analysis, question 22
was modified to use the word withdrawn instead of
insecure. The rough draft of the scale was applied on
two occasions, 2 weeks apart, to a pilot group of 30
randomly selected children 8 to 15 years of age from a
public school in Valdivia. The total score obtained in
both applications was analyzed by means of the
intraclass correlation coefficient R. This test had a high
test-retest reliability (intraclass correlation coefficient
Page 2
 Aravena et al., QUALITY OF LIFE IN CHILEAN CHILDREN WITH CLEFT LIP/PALATE 0

TABLE 1 Sociodemographic Characteristics and Treatment intraoral exploration mirror without magnification,
History of Patient Group With Cleft Lip and/or Palate in Cities of applying the DMFT index.
Chile
In the group of children with CL/P, independent
Valdivia, Santiago, Puerto Montt, Total, variables related to the sociodemographic data and
n ¼ 29 n ¼ 12 n¼7 N ¼ 48 history of treatment for CL/P were recorded by
Age, average (SD) 11.5 (2.5) 10.5 (2.1) 11.7 (1.7) 11.3 (2.3) interviewing the parents (Table 1): age (in years), gender
Gender (male/female), diagnosis of the cleft according to the
Male, n (%) 19 (65.5) 6 (50.0) 5 (71.4) 30 (62.5) classification of Clinical Guide for Cleft Lip-Palate (cleft
Cleft diagnosis lip, prepalatal cleft, or primary palate cleft; cleft palate
Cleft lip, n (%) 3 (10.3) 2 (16.6) 0 (0.0) 5 (10.4) or cleft hard and/or soft palate; cleft lip-palate;
Cleft palate, MINSAL, 2009), side affected by the cleft (left, right,
n (%) 8 (27.5) 5 (41.6) 0 (0.0) 13 (27.0)
Cleft lip-palate, bilateral, medial cleft palate), use of presurgical
n (%) 18 (62.0) 5 (41.6) 7 (100.0) 30 (62.5) orthopedic apparatus (yes/no), number of surgeries
Cleft side under general anesthesia (No. of surgeries), age at first
Left, n (%) 7 (24.1) 2 (16.6) 6 (85.7) 15 (31.2) surgery (months), and age at last surgery (years). Only
Right, n (%) 7 (24.1) 3 (25.0) 0 (0.0) 10 (20.8) the child’s age (years) and gender (male/female) were
Bilateral, n (%) 7 (24.1) 2 (16.6) 1 (14.2) 10 (20.8)
Median cleft palate, recorded for the control group.
n (%) 8 (27.5) 5 (41.6) 0 (0.0) 13 (27.0) The oral health–related quality of life score from the
Presurgical orthopedics COHIP-Sp was recorded as a dependent variable,
Yes, n (%) 15 (51.7) 9 (75.0) 4 (57.1) 28 (58.3) obtaining the average score of the participants from
Number of surgeries each group by items, domain, and sum of the total
Average no. (SD) 3.2 (2.0) 3.6 (2.9) 4.5 (1.6) 3.5 (2.2) points from the scale.
Age at first surgery
Average months Data Analysis
(SD) 9.5 (10.0) 6.4 (2.1) 5.8 (4.5) 8.2 (8.1)
Age at last surgery The variables were analyzed with descriptive statistics,
Average years (SD) 7.0 (4.5) 6.0 (4.0) 9.1 (3.8) 7.1 (4.3) presenting the results with dispersion measurements and
central tendency (average 6 standard deviation). To
compare the quality of life between the study groups,
[ICC] . .8) for questions 2, 9, 10, 11, 14, 17, 20, 23, 26,
the parametric/nonparametric distribution of the total
28, and 30, and the total ICC of the instrument was .89
average score of the scale in both was analyzed using the
(Norman and Streiner, 2008). Shapiro-Wilk test (P , .05). According to the result, the
scores were compared to total average, average of
Application of the COHIP-Sp domains, and the items on the scale with the corre-
sponding test (t test/Mann-Whitney U test). An index
The second stage was to apply the COHIP-Sp. For for a better quality of life was determined when the
this, participants were contacted by telephone between average of the score from the scale was significantly
August and October 2014. In the group of children with higher between the two groups (P , .05; 95%
CL/P, two investigators (T.G. and T.O.) applied the confidence interval).
COHIP-Sp according to the geographical location and The analyses were done with the statistical R Core
willingness of the family to participate. Sociodemo- Team program (2013).
graphic data and history of treatment for CL/P were
recorded based on an interview with the parents. For the RESULTS
control group, the investigators visited the children and
parents at their schools after coordinating with the Table 1 presents the sociodemographic information,
diagnostic history, and treatment for the group of children
establishment’s administration. In both groups, the
with CL/P.
objective of the scale was explained orally. Once the
The distribution analysis of the averages of the score
children agreed to participate, they were given the scale
showed a nonparametric distribution in the group of
in writing. Each child was left alone in a physical place children with CL/P (P¼ .47) and parametric for the control
free of visual or auditory interference. After adminis- group (P¼.03). The average overall score of the COHIP-Sp
tering the questionnaire, a basic oral examination was was 94.1 6 19.3 for the group of children with CL/P and
performed to match the training groups. For this, each 97.1 6 15.6 for the control group, there being no
child sat in a chair with full neck extension and statistically significant difference (P ¼ .31). However, the
maximum oral opening. An investigator (T.G.) used a analysis of the average score in the domains on the scale
flashlight with a frontal headpiece and a flat No. 5 revealed significantly unfavorable differences for the

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 0 Cleft Palate–Craniofacial Journal, March 2016, Vol. 53 No. 2

Table 2 Average Scale Score of the COHIP-Sp and Domains (Score Range 0–4 Points)

Cleft Lip and/or Control Group,

Palate Group, n ¼ 48 n ¼ 96
Average
Child Oral Health Impact Profile Domains and Items (n of Items)† (SD) CI 95% Average (SD) CI 95% P Value‡

Oral health well-being (10) 24.5 (6) (22.7–26.2) 25.1 (5.6) (23.9–26.2) .5490
Functional well-being (6) 16.8 (4.2) (15.5–18.0) 19.2 (4.1) (18.4–20.1) .0013*
Had trouble biting off or chewing foods such as apple, carrot, or firm
meat 2.8 (1.2) (2.5–3.2) 3.1 (1.2) (2.8–3.3) .3393
Had difficulty eating foods you would like to eat because of your teeth,
mouth, or face 3.4 (0.9) (3.1–3.7) 3.3 (0.9) (3.1–3.5) .4399
Had trouble sleeping because of your teeth, mouth, or face 3.3 (1) (3.1–3.6) 3.5 (0.8) (3.3–3.6) .5251
Had difficultly saying certain words because of your teeth, mouth, or face 2.1 (1.2) (1.7–2.4) 3.3 (0.9) (3.1–3.5) .0001*
Had people have difficulty understanding what you were saying because
of your teeth, mouth, or face 2.5 (1.3) (2.1–2.9) 3.1 (1.1) (2.9–3.4) .0033*
Had difficulty keeping your teeth clean because of your teeth, mouth, or
face 2.4 (1.1) (2.1–2.7) 2.7 (0.1) (2.5–3) .1054
Social-emotional well-being (8) 22.5 (7.4) (20.4–24.7) 24.4 (5.6) (23.2–25.5) .0981
School environment (4) 12.9 (2.6) (12.1–13.7) 14.3 (2.2) (13.8–14.7) .0013*
Missed school for any reason because of your teeth, mouth, or face 2.7 (1) (2.4–3) 3.3 (0.9) (3.1–3.4) .0040*
Had difficulty paying attention in school because of your teeth, mouth,
or face 3.1 (1.2) (2.8–3.5) 3.6 (0.6) (3.5–3.7) .0045*
Not wanted to speak/read aloud in class because of your teeth, mouth, or
face 3.3 (1.1) (3–3.6) 3.6 (0.8) (3.5–3.8) .0318*
Not wanted to go to school because of your teeth, mouth, or face 3.6 (0.8) (3.3–3.8) 3.6 (0.7) (3.5–3.8) .6042
Self-image (6) 17.2 (5.3) (15.8–18.8) 13.9 (4.6) (13–14.9) .0002*
Been confident because of your teeth, mouth, or face 2.5 (1.3) (2.1–2.9) 1.9 (1.4) (1.6–2.2) .0152*
Felt that you were attractive (good looking) because of your teeth,
mouth, or face 2 (1.4) (1.6–2.5) 1.1 (1.1) (0.8–1.3) .0001*
I have good teeth 2.3 (1.3) (1.9–2.7) 1.7 (1.3) (1.5–2.1) .0246*
I feel good about myself 3.4 (1.1) (3–3.7) 2.8 (1.3) (2.5–3.1) .0117*
When I am older, I believe (think) that I will have good teeth 3.4 (1) (3.1–3.7) 3.1 (1.1) (2.9–3.3) .1267
When I am older, I believe (think) that I will have good health 3.4 (0.9) (3.1–3.7) 3.2 (1) (3–3.4) .1749
COHIP-Sp (34) 94.1 (19.3) (88.5–99.7) 97.1 (15.6) (93.9–100.3) .3190
† Items are shown in detail in those domains with statistically significant differences.
Mann-Whitney U test.
* P , .05.

children with CL/P in the areas of ‘‘functional well-being’’
(P ¼ .0013) and ‘‘school environment’’ (P ¼ .0013), whereas
in the domain ‘‘self-image,’’ the difference was favorable to
the group of children with CL/P (P ¼ .0002). The
comparative analysis of the scores from the domains and
items of the COHIP-Sp between the two groups appears in
Table 2.
DISCUSSION
Oral health–related quality of life based on the COHIP-
Sp in children with history of surgically treated CL/P
showed indices similar to children unaffected in a Chilean
population. Nevertheless, the influence of the condition of
CL/P was observed in relation to a lower quality-of-life
score in some aspects such as functional well-being and
school environment.
The present study found a greater number of male
children with CL/P and the left side more affected with a
diagnosis of cleft lip-palate, with demographic data similar
to that reported in Dutch and Colombian populations
(Lucas et al., 2000; Hurtado et al., 2008). The average of the
oral health–related quality of life in the group of children
with CL/P was lower than the group control by only three
points. This result is consistent with that reported by Broder
and Wilson-Genderson (2007) and Ward et al. (2013) in a
population of American children with CL/P. In terms of
functional well-being, the lower score reported by these
patients occurred in the questions related to speaking in
public and speaking or reading aloud at school (Table 2).
These results are consistent with those described by
Chetpakdeechit et al. (2009) in a Swedish population. This
can be explained because secondary cleft palates are often
associated with speech problems such as hypernasality and
more concretely velar insufficiency (Hudon, 1997, cited by
Chapados, 2000) characterized by hypernasal resonance
and reduced intraoral pressure when pronouncing conso-
nants, which causes the audible nasal sound during speech
(Smith & Guyette, 2004, cited by Sullivan et al., 2011),
directly affecting their social integration and cultural
adaptation in adulthood (Berk et al., 2001). In addition, it
should be pointed out that children miss school, and their
emotional control or social interaction is hindered for
reasons associated with the teeth, mouth, and face
(Chetpakdeechit et al., 2009) or the presence of otitis media
with effusion (Tierney et al., 2015).

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 Aravena et al., QUALITY OF LIFE IN CHILEAN CHILDREN WITH CLEFT LIP/PALATE
The only domain that showed a positive statistically
significant difference for the group of patients with CL/P
was ‘‘self-image’’ (P ¼ .0002;Table 2). The literature is not
conclusive on this topic. Reports from these patients show
lower self-esteem in the population with a history of CL/P
(Berk et al., 2001). Nevertheless, the studies by Hunt et al.
(2005) and Vinaccia et al. (2008) present conclusions similar
to this study, arguing that the patients’ acceptance of their
CL/P tends to lead to a more favorable self-image.
The limitations of this investigation relate to the
validation of the scale in terms of the reduced number of
participants in the study group and a validity analysis
limited to the test-retest reliability and face validity. In
terms of the selected sample, there may be influence on the
results given the age differences, geographic condition, and
socioeconomic and cultural status of the participants in the
study groups and their comparability. Furthermore, the
small number of participants with CL/P may cause those
items on the scale to show a false statistical association with
low quality-of-life scores observed in the group with CL/P.
With respect to the application of the scale, the results
could be affected by the high number of questions on the
instrument, which could affect the child’s concentration, in
addition the wide age range of the participants (8 to 15
years), which could influence level of reading comprehen-
sion of the questionnaire. Despite these limitations, the use
of the COHIP scale demonstrated good reliability, similar
to the coefficient level previously reported for an American
population (Broder and Wilson-Genderson, 2007). In
addition, to enhance the power of the study and the
external validity of the results, the study groups were
matched by considering double observations in the control
group to increase the statistical power given the reduced
number of subjects with CL/P (Argimon and Jiménez,
2004), and the DMFT index avoided bias in differences in
the quality-of-life results in relation to this variable (Lucas
et al., 2000).
In conclusion, oral health–related quality of life in
children treated for CL/P was similar to the children
unaffected by CL/P, being positive in terms of their self-
image. However, a lower quality of life was observed in
areas such as functional well-being and school environ-
ment. This investigation has been a first step in the research
line of oral health–related quality of life of patients with
cleft lip-palate in the Latin American region. Nevertheless,
it is suggested that studies in this vein should continue, and
researchers should conduct risk factor analyses associated
with the levels of quality of life of children with CL/P
detectable in the surgical or rehabilitative treatment, as well
as analyze the quality of life in children or adult populations
in Hispano-America.
Acknowledgments. The authors thank the surgeons and research team
members at their three study sites: Dr. Fernando Salinas (Hospital Base in
Valdivia), Dr. Roberto Pantoja (San Borja Arriarán Hospital in Santiago),
and Ms. Claudia Aguilera Susuki (School of Speech Therapy and
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0
Assistance Network for Children with Cleft Lip/Palate in Puerto Montt
and Gantz Fundation of Child Cleft Palate in Santiago). We are grateful
for all parents and children who participated voluntarily in this research.
For them, our thanks and respect.
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 Queries for cpcj-53-02-07

1. Author: This article has been lightly edited for grammar, style, and usage. Please compare it with your original
document and make corrections on these pages. Please limit your corrections to substantive changes that affect
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2. Author: For the affiliations of Ms. González and Ms. Oyarzún, please provide the institution or location where they
are employed as dentists. Copy editor
3. Author: In the first paragraph of the Design and Patients section, please define the abbreviation ‘‘DMFT.’’ Copy
editor

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