Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT05755464 |
| Other study ID # |
1946 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2018 |
| Est. completion date |
September 20, 2024 |
Study information
| Verified date |
February 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Since subjects with Down Syndrome (DS) have different and variable levels of intellectual
deficit, in approaching the patient with DS and before evaluating the different therapeutic
strategies and carrying out a dental and orthodontic treatment, an initial analysis would be
useful the patient's level of cooperation.
The hypothesis underlying the study is the possibility of predicting the degree of success of
dental and orthodontic treatment in the patient with Down's Syndrome by completing an
evaluation form by the clinician. The general objective of the study is to test the
effectiveness of the module in assessing and quantifying the degree of patient collaboration.
This form is filled in entirely during the first visit and updated in subsequent sessions in
conjunction with the different operational phases.
Based on the score obtained by the patient, the clinician can hypothesize the degree of
cooperation during the operative sessions and compliance with the indications provided.
Therefore, the evaluation of the score obtained will guide the clinician in choosing the type
of therapy that will have the least risk of failure because this will be chosen having
evaluated not only the dental and/or orthodontic therapeutic needs, but also the real ability
of the patient to collaborate.
Description:
In the planning and management of dental and/or orthodontic treatments aimed at people with
intellectual disabilities, the role of the clinician and his ability to empathize with the
patient in order to obtain collaboration in treatment is fundamental. For these reasons it is
necessary that, before planning the therapy, he can carry out a careful and complete
evaluation of the behavioral profile that these subjects manifest.
Given the scarce presence in the literature of studies relating to an a priori evaluation of
patient collaboration, this study aims to propose an objective and reproducible protocol to
evaluate the patient's behavioral typology at the beginning of the treatment relationship, so
as to improve the quality of the diagnosis and subsequent treatment of the patient by
directing the clinician towards the most appropriate and effective treatment.
Down syndrome (DS), which our study deals with, is the result of trisomy of chromosome 21,
and is considered the main genetic cause of mental disability. Trisomy of chromosome 21
affects both physical and cognitive development and results in a characteristic behavioral
phenotype; however, the individuals concerned show a great variability of behavior in
relation to the severity of the specific deficit, and this affects the chances of success of
a dental treatment and, if necessary, the success and stability in the short and long term
long-term orthodontic treatment.
In subjects with Down syndrome orofacial dyskinesia has a high prevalence and consists of a
set of abnormal and involuntary movements of the facial muscles and/or masticatory muscles,
which determine mandibular movements in protrusion and bruxism. Due to the marked orofacial
hypotonia, the subject encounters considerable difficulties in sucking, swallowing, speaking
and chewing from the first years of life. For this reason, an intervention aimed at solving
the problems relating to swallowing, phonation, breathing and chewing is necessary, since
these anomalies can preclude the possibility of a normal integration into the social context
and relationship life by these subjects.
Furthermore, obstructive sleep apnea syndrome (OSAS) is significantly more prevalent among
children with DS than in the general population, and a bidirectional and complex link between
sleep disturbances and pediatric health has been demonstrated: sleep disturbances they have
been associated with the development of obesity and cardiovascular abnormalities, epilepsy,
autism spectrum disorders, attention deficit hyperactivity disorder (ADHD), mood and anxiety
disorders, and a wide range of neurocognitive problems.
At the level of the oral cavity, a greater prevalence of oligodontia has been demonstrated in
subjects with Down syndrome: the teeth that are most frequently missing are the third molars,
followed by the second premolars and the incisors. Some patients may also have deciduous
teeth even in adulthood. Individuals with Down syndrome also have microdontia affecting all
teeth except the upper first molars and lower incisors. A higher prevalence of class III
malocclusion can also be observed in these individuals compared to the general population;
this could be attributed to altered skull-to-bone ratios, reduced size of the dental arches,
and decreased jaw size in patients with Down syndrome. Another interesting fact is that these
subjects show a higher incidence of fractures of the dental elements than the general
population, mainly affecting the upper incisors, due to the greater frequency of severe
maxillary overjet, class II-I division malocclusion, short or incompetent superior and a
greater accident proneness.
At the craniofacial level in the subject with DS the height of the palate is significantly
reduced and the presence of a "torus palatine" can easily be found which gives the palate a
characteristic "W" shape; this is frequently associated with upper airway obstruction. The
presence in such subjects of a high arched palate and the reduction of the nasal septum
contribute to a considerable narrowing of the nasal antrum and therefore limit the
development of the upper airways. Because of this, children with DS are forced to breathe
through their mouths and maintain a low tongue posture and are therefore termed oral
breathers. Therefore, the lack of ventilation of the upper airways does not cause the
flattening action of the floor of the nasal cavities operated by the air flow. In oral
respirator it is also important to evaluate the state of the adenoids, the presence of
hypertrophic tonsils and any allergic diseases (allergic rhinitis, bronchial asthma).
Furthermore, in a study by Oliveira et al. it was observed that at the oral level there was a
direct correlation between the presence of airway infections in the 6 months prior to the
trial and an increased risk of 2.47 of developing posterior crossbite.
Untreated oral respiratory subjects may develop a distinctive facial profile, with long
narrow faces, narrow jaws, a high-arched palate with dental malocclusion, a gingival smile,
and skeletal class III. For these reasons, an early and specific orthodontic treatment is
essential: the expansion of the palate in fact determines an increase in the nasal volume and
in the ability to implement nasal rather than oral breathing.
For these reasons, an adequate medical approach, combined with early dental intervention, can
lead to a reduction in the prevalence of malocclusions in subjects with DS, with a consequent
beneficial effect on the development of these subjects. In order to improve the oral health
of these individuals, defined as "special needs patients", it is essential that the public
health services that deal with oral health introduce intervention methods dedicated to the
prevention and treatment of malocclusions. It is therefore essential to understand the
panorama of the dental needs of people with disabilities in order to ensure treatments that
can help this component of the population overcome difficulties and improve their growth
opportunities and quality of life.
In these subjects it is possible to find deviations from the norm with regard to the size,
shape or position of the maxilla and mandible. The types of malocclusion most commonly found
in these subjects are dental crowding, open bite, mono- or bilateral crossbite and skeletal
class III. Malocclusion in these subjects not only negatively affects functions such as
chewing, language, sucking and swallowing, but also has important consequences on the
psychological profile due to unacceptable dental aesthetics.
The implementation of orthodontic treatments in subjects with DS has the objective of
restoring normal masticatory function and of creating greater resistance to the disease and
an overall improvement of the personal appearance, which contributes positively to the
physical and mental well-being of the subject. In fact, analyzing the picture in relation to
the aesthetic aspect, it can be observed how the presence of bad breath, dental malposition,
trauma, gum bleeding, open mouth posture and excessive salivation can lead to feelings of
compassion or repugnance and discrimination from others individuals, thus accentuating a
tendency to isolate these subjects from the life of society.
The patient with Down syndrome represents an ideal candidate to carry out a study aimed at
evaluating the collaboration in dental and orthodontic treatments, since he presents a series
of peculiar orthodontic anomalies, such as 3rd class malocclusion, open bite, cross bite and
agenesis; it has also been observed that subjects with DS show a very different degree of
collaboration based on the severity of the developmental and behavioral deficits.
Consequently, some of them will show a more positive and favorable attitude towards dental
care, while others will be treatable with more difficulty or treatable exclusively in partial
or total sedation. For these reasons, although the need for orthodontic treatment is often
present, this is not always feasible until all the treatment objectives have been achieved:
in fact, often, due to the poor collaboration of patients with Down syndrome, partial
objectives are established and /or minimally invasive orthodontic means are used with limited
results.
