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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 Region in the south of Chile show this prevalence increasing
frequent congenital malformations, with a worldwide to 2.03 per 1000 live births (Rosa, 2010).
prevalence estimated at 0.8/1000 live births (World Health The treatment of patients with CL/P seeks to achieve
Organization, Human Genetics Programme, 2002), and normal growth and development of the face, complete
there is a significant variation in global incidence, closure of the cleft, comprehensible speech, normal hearing,
depending on geography, gender, race, and ethnic group, a good esthetic result, and consequently correct socializa-
among others (Rozendaal et al., 2012). South America has tion (Eberlinc and Koželj, 2012). There are, however,
one of the highest frequencies in the world: in Bolivia, it is certain sequelae that will influence quality of life, such as
2.5 per 1000 live births and in Argentina, 1.5 per 1000 live difficulties in eating, speaking, oral hygiene, esthetics,
births (Nazer et al., 2010). Colombia and Brazil have growth, and other physical problems such as ear infections,
reported a prevalence of 1 per 1000 live births (Hurtado et alterations in hearing, and a psychosocial burden (Ward et
al., 2008; Raposo-do-Amaral et al., 2011). In Chile, the al., 2013). Oral health complications are numerous,
reported frequency is 1.8 per 1000 live births, with 452 new including dental agenesis and supernumerary and poorly
cases reported annually (Chilean Ministry of Health positioned teeth (Chapados, 2000), and cause speech
[MINSAL], 2009); however, local reports in the Los Rı́os 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
Dr. Aravena is Professor, Institute of Anatomy, Histology and (Broder et al., 1994; Berk et al., 2001). In response to this
Pathology, Faculty of Medicine, Universidad Austral de Chile,
Valdivia, Chile. Ms. González and Ms. Oyarzún are Dentists, location.
situation, the measurement of oral health–related quality of
Mr. Coronado is Professor, Department of Morphofunction, Faculty life has become an important health indicator and reveals
of Medicine, Universidad Diego Portales, Santiago, Chile. the functional and psychosocial results of oral diseases and
Financial support: This study had private financial support from the
researchers and the School of Dentistry, Universidad Austral de Chile.
conditions (Cohen, 1997, quoted by Do and Spencer, 2008).
Submitted March 2015; Revised May 2015; Accepted May 2015. Broder and Wilson-Genderson (2007) adapted and
Address correspondence to: Dr. Pedro C. Aravena, School of validated the Child Oral Health Impact Profile (COHIP)
Dentistry, Universidad Austral de Chile, 1640 Rudloff Street,
Valdivia, Chile. E-mail paravena@uach.cl. in English to measure quality of life in terms of oral health,
DOI: 10.1597/15-095 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, participate through a written informed consent, and
recruiting participants with various oral health conditions whose parents signed an informed consent. Children or
such as craniofacial, orthodontic, and general pediatric adolescents who presented a disabling medical condi-
dental anomalies. This scale presented a high internal tion, syndromic CL/P, or mental disorders were
consistency and an excellent test-retest reliability, contrib- excluded. The children in the control group were
uting a valuable instrument for the assessment of the oral selected by means of simple random sampling from five
health–related quality of life in children with CL/P (Broder public schools in Valdivia.
et al., 2014). Regarding the external validity of our results, the
The use of the COHIP in children with CL/P could show sample size was based on the incidence rate of children
the impact of this condition and sequelae after treatment with CL/P in Chile calculated on the basis of a power of
such as esthetic and speech problems, nervousness when 80%, 95% confidence level according to the overall
speaking in public or at school (Chetpakdeechit et al., 2009) population of Valdivia consistent with its overall birth
or obvious self-image problems (Berk et al., 2001); rate and rate of live births with CL/P in Chile ¼ 1.8/1000
therefore, the use of the COHIP at the local level could (MINSAL, 2009). This calculation detected a difference
reveal similar and relevant issues to ascertain the oral health of 13.3 points on the overall COHIP score between
of this population. children with CL/P and the control group (Broder and
In light of the bibliographic references presented, we Wilson-Genderson, 2007; Ward et al., 2013) and
propose the following hypothesis: children between 8 and matching with double the number of subjects in the
15 with a history of surgically treated CL/P exhibit an oral control group (Argimon and Jiménez, 2004). This
health–related quality of life similar to children unaffected calculation provided a minimum number of 31 subjects
by this condition in a Chilean population. between 8 and 15 years (EPIDAT 3.0, Statistical
The aim of this study was to determine oral health– Analysis Software)
related quality of life by means of an adapted Spanish-
language version of the COHIP in children and adolescents Adaptation and Validity of the COHIP to Spanish
between 8 and 15 years old treated surgically for non-
syndromic CL/P and to compare it with children and The first stage was to adapt the COHIP to Spanish.
adolescents unaffected by CL/P in a Chilean population. This instrument is composed of five domains (well-being
in oral health, functional well-being, social-emotional
METHODS well-being, school environment, and self-image), with a
total of 34 items. Each item is valued on a 5-item Likert-
Design and Patients 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),
A cross-sectional study with a matched case-control with the exception of the domain ‘‘self-image,’’ which
design was conducted and approved for the Ethical and presents a score assigned with an ordinal and increasing
Research Committee of the Regional of Health Depart- number (Broder, 2007). The questions with no response
ment of Chile (Register No. 152/2014). Forty-eight are scored as zero. The total score of the scale varies
children and adolescents with a history of CL/P between 0 and 136, where a higher score corresponds to
participated (average age 11.3 6 2.3 years; 62.5% male) a better oral health–related quality of life (Broder and
and were treated surgically in primary care hospitals in Wilson-Genderson, 2007).
Chile: Hospital Base in Valdivia, San Borja Arriarán In its adaptation, the COHIP was translated from
Hospital in Santiago, and the Assistance Network for English to Spanish simultaneously by two investigators
Children With Cleft Lip/Palate in Puerto Montt City. In (T.G. and T.O.), who then agreed with a third English-
addition, there was a control group of 96 children and speaking investigator on a definitive version called
adolescents unaffected by CL/P (average age 11.2 6 2.3 COHIP-Sp. This was taken to a qualitative review
years; 46.8% male) from public schools in Valdivia, process in terms of face and construct validity by five
Chile. For matching the two study groups, a number of experts in the treatment of children with CL/P and a
children were selected at a 2:1 ratio between unaffected focus group with 15 children from 8 to 15 years old from
children and those with a history of CL/P and of similar a public school in Valdivia. In this analysis, question 22
?3 age, gender, and the same DMFT index (Lucas et al., was modified to use the word withdrawn instead of
2000), as this index was statistically similar between the insecure. The rough draft of the scale was applied on
two groups (CL/P group DMFT index ¼ 2.2 6 2.8; two occasions, 2 weeks apart, to a pilot group of 30
control group DMFT index ¼ 2.7 6 2.6; P . .05). randomly selected children 8 to 15 years of age from a
The group of children with a history of CL/P was public school in Valdivia. The total score obtained in
selected by convenience sampling. Those children both applications was analyzed by means of the
between 8 and 15 years of age were included who could intraclass correlation coefficient R. This test had a high
read and write in Spanish, who agreed voluntarily to test-retest reliability (intraclass correlation coefficient

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

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Aravena et al., QUALITY OF LIFE IN CHILEAN CHILDREN WITH CLEFT LIP/PALATE 0

The only domain that showed a positive statistically Assistance Network for Children with Cleft Lip/Palate in Puerto Montt
significant difference for the group of patients with CL/P and Gantz Fundation of Child Cleft Palate in Santiago). We are grateful
for all parents and children who participated voluntarily in this research.
was ‘‘self-image’’ (P ¼ .0002;Table 2). The literature is not For them, our thanks and respect.
conclusive on this topic. Reports from these patients show
lower self-esteem in the population with a history of CL/P
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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
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